Trial Outcomes & Findings for Efficacy and Safety of Pembrolizumab Plus Investigational Agents in Combination With Chemotherapy as First-Line Treatment in Extensive-Stage Small Cell Lung Cancer (ES-SCLC) (MK-3475-B99/ KEYNOTE-B99) (NCT NCT04924101)
NCT ID: NCT04924101
Last Updated: 2026-08-13
Results Overview
ORR is defined as the percentage of participants with Complete Response (CR: disappearance of all target lesions) or Partial Response (PR: at least a 30% decrease in the sum of diameters of target lesions) per RECIST 1.1. The percentage of participants who experience CR or PR as assessed by BICR is presented.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
122 participants
Primary outcome timeframe
Up to approximately 43 months
Results posted on
2026-08-13
Participant Flow
Participant milestones
| Measure |
Pembrolizumab + MK-4830 + Chemotherapy
Participants receive pembrolizumab 200 mg intravenous (IV) infusion on Day 1 of each cycle (cycle length = 3 weeks) every 3 weeks (Q3W) up to 35 administrations (up to approximately 2 years) or until progressive disease (PD) or discontinuation, MK-4830 800 mg IV infusion on Day 1 of each cycle Q3W, up to 35 administrations (up to approximately 2 years) or until PD or discontinuation; etoposide 100 mg/m\^2 IV infusion on Days 1, 2, 3 of each cycle for up to 4 cycles (up to approximately 12 weeks) and cisplatin 75 mg/m\^2 IV infusion or carboplatin AUC 5 mg/ml/min IV infusion (AUC = area under the curve) on Day 1 of each cycle Q3W up to 4 cycles (up to approximately 12 weeks) or until PD or discontinuation.
|
Pembrolizumab + Boserolimab + Chemotherapy
Participants receive pembrolizumab 200 mg IV infusion on Day 1 of each cycle Q3W up to 35 administrations (up to approximately 2 years) or until PD or discontinuation, boserolimab 30 mg IV infusion on Day 1 of each cycle (cycle length = 6 weeks) every 6 weeks (Q6W), up to 18 administrations (up to approximately 2 years) or until PD or discontinuation; etoposide 100 mg/m\^2 IV infusion on Days 1, 2, 3 of each cycle for up to 4 cycles (up to approximately 12 weeks) and cisplatin 75 mg/m\^2 IV infusion or carboplatin AUC 5 mg/ml/min IV infusion, Day 1 of each cycle Q3W up to 4 cycles (up to approximately 12 weeks) or until PD or discontinuation.
|
Pembrolizumab + Lenvatinib + Chemotherapy
Participants receive pembrolizumab 200 mg IV infusion on Day 1 of each 3 week cycle (Q3W) up to 35 administrations (up to approximately 2 years) or until PD or discontinuation, lenvatinib 8 mg once daily (QD) orally for Cycles 1-4 and up to 20 mg QD orally for Cycles 5-35 or until PD or discontinuation; etoposide 100 mg/m\^2 IV infusion on Days 1, 2, 3 of each cycle for up to 4 cycles (up to approximately 12 weeks) and cisplatin 75 mg/m\^2 IV infusion or carboplatin AUC 5 mg/ml/min IV infusion, Day 1 of each cycle Q3W up to 4 cycles (up to approximately 12 weeks) or until PD or discontinuation.
|
|---|---|---|---|
|
Overall Study
STARTED
|
43
|
41
|
38
|
|
Overall Study
COMPLETED
|
0
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
43
|
41
|
38
|
Reasons for withdrawal
| Measure |
Pembrolizumab + MK-4830 + Chemotherapy
Participants receive pembrolizumab 200 mg intravenous (IV) infusion on Day 1 of each cycle (cycle length = 3 weeks) every 3 weeks (Q3W) up to 35 administrations (up to approximately 2 years) or until progressive disease (PD) or discontinuation, MK-4830 800 mg IV infusion on Day 1 of each cycle Q3W, up to 35 administrations (up to approximately 2 years) or until PD or discontinuation; etoposide 100 mg/m\^2 IV infusion on Days 1, 2, 3 of each cycle for up to 4 cycles (up to approximately 12 weeks) and cisplatin 75 mg/m\^2 IV infusion or carboplatin AUC 5 mg/ml/min IV infusion (AUC = area under the curve) on Day 1 of each cycle Q3W up to 4 cycles (up to approximately 12 weeks) or until PD or discontinuation.
|
Pembrolizumab + Boserolimab + Chemotherapy
Participants receive pembrolizumab 200 mg IV infusion on Day 1 of each cycle Q3W up to 35 administrations (up to approximately 2 years) or until PD or discontinuation, boserolimab 30 mg IV infusion on Day 1 of each cycle (cycle length = 6 weeks) every 6 weeks (Q6W), up to 18 administrations (up to approximately 2 years) or until PD or discontinuation; etoposide 100 mg/m\^2 IV infusion on Days 1, 2, 3 of each cycle for up to 4 cycles (up to approximately 12 weeks) and cisplatin 75 mg/m\^2 IV infusion or carboplatin AUC 5 mg/ml/min IV infusion, Day 1 of each cycle Q3W up to 4 cycles (up to approximately 12 weeks) or until PD or discontinuation.
|
Pembrolizumab + Lenvatinib + Chemotherapy
Participants receive pembrolizumab 200 mg IV infusion on Day 1 of each 3 week cycle (Q3W) up to 35 administrations (up to approximately 2 years) or until PD or discontinuation, lenvatinib 8 mg once daily (QD) orally for Cycles 1-4 and up to 20 mg QD orally for Cycles 5-35 or until PD or discontinuation; etoposide 100 mg/m\^2 IV infusion on Days 1, 2, 3 of each cycle for up to 4 cycles (up to approximately 12 weeks) and cisplatin 75 mg/m\^2 IV infusion or carboplatin AUC 5 mg/ml/min IV infusion, Day 1 of each cycle Q3W up to 4 cycles (up to approximately 12 weeks) or until PD or discontinuation.
|
|---|---|---|---|
|
Overall Study
(sponsor decision)
|
13
|
10
|
9
|
|
Overall Study
Withdrawal by Subject
|
3
|
0
|
1
|
|
Overall Study
Death
|
27
|
31
|
28
|
Baseline Characteristics
Efficacy and Safety of Pembrolizumab Plus Investigational Agents in Combination With Chemotherapy as First-Line Treatment in Extensive-Stage Small Cell Lung Cancer (ES-SCLC) (MK-3475-B99/ KEYNOTE-B99)
Baseline characteristics by cohort
| Measure |
Pembrolizumab + MK-4830 + Chemotherapy
n=43 Participants
Participants receive pembrolizumab 200 mg intravenous (IV) infusion on Day 1 of each cycle (cycle length = 3 weeks) every 3 weeks (Q3W) up to 35 administrations (up to approximately 2 years) or until progressive disease (PD) or discontinuation, MK-4830 800 mg IV infusion on Day 1 of each cycle Q3W, up to 35 administrations (up to approximately 2 years) or until PD or discontinuation; etoposide 100 mg/m\^2 IV infusion on Days 1, 2, 3 of each cycle for up to 4 cycles (up to approximately 12 weeks) and cisplatin 75 mg/m\^2 IV infusion or carboplatin AUC 5 mg/ml/min IV infusion (AUC = area under the curve) on Day 1 of each cycle Q3W up to 4 cycles (up to approximately 12 weeks) or until PD or discontinuation.
|
Pembrolizumab + Boserolimab + Chemotherapy
n=41 Participants
Participants receive pembrolizumab 200 mg IV infusion on Day 1 of each cycle Q3W up to 35 administrations (up to approximately 2 years) or until PD or discontinuation, boserolimab 30 mg IV infusion on Day 1 of each cycle (cycle length = 6 weeks) every 6 weeks (Q6W), up to 18 administrations (up to approximately 2 years) or until PD or discontinuation; etoposide 100 mg/m\^2 IV infusion on Days 1, 2, 3 of each cycle for up to 4 cycles (up to approximately 12 weeks) and cisplatin 75 mg/m\^2 IV infusion or carboplatin AUC 5 mg/ml/min IV infusion, Day 1 of each cycle Q3W up to 4 cycles (up to approximately 12 weeks) or until PD or discontinuation.
|
Pembrolizumab + Lenvatinib + Chemotherapy
n=38 Participants
Participants receive pembrolizumab 200 mg IV infusion on Day 1 of each 3 week cycle (Q3W) up to 35 administrations (up to approximately 2 years) or until PD or discontinuation, lenvatinib 8 mg once daily (QD) orally for Cycles 1-4 and up to 20 mg QD orally for Cycles 5-35 or until PD or discontinuation; etoposide 100 mg/m\^2 IV infusion on Days 1, 2, 3 of each cycle for up to 4 cycles (up to approximately 12 weeks) and cisplatin 75 mg/m\^2 IV infusion or carboplatin AUC 5 mg/ml/min IV infusion, Day 1 of each cycle Q3W up to 4 cycles (up to approximately 12 weeks) or until PD or discontinuation.
|
Total
n=122 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
64.0 Years
STANDARD_DEVIATION 8.8 • n=1 Participants
|
62.0 Years
STANDARD_DEVIATION 9.9 • n=1 Participants
|
65.9 Years
STANDARD_DEVIATION 10.2 • n=1 Participants
|
63.9 Years
STANDARD_DEVIATION 9.7 • n=2 Participants
|
|
Sex: Female, Male
Female
|
9 Participants
n=1 Participants
|
13 Participants
n=1 Participants
|
9 Participants
n=1 Participants
|
31 Participants
n=2 Participants
|
|
Sex: Female, Male
Male
|
34 Participants
n=1 Participants
|
28 Participants
n=1 Participants
|
29 Participants
n=1 Participants
|
91 Participants
n=2 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=1 Participants
|
0 Participants
n=1 Participants
|
0 Participants
n=1 Participants
|
1 Participants
n=2 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
41 Participants
n=1 Participants
|
40 Participants
n=1 Participants
|
38 Participants
n=1 Participants
|
119 Participants
n=2 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=1 Participants
|
1 Participants
n=1 Participants
|
0 Participants
n=1 Participants
|
2 Participants
n=2 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=1 Participants
|
0 Participants
n=1 Participants
|
0 Participants
n=1 Participants
|
0 Participants
n=2 Participants
|
|
Race (NIH/OMB)
Asian
|
10 Participants
n=1 Participants
|
6 Participants
n=1 Participants
|
20 Participants
n=1 Participants
|
36 Participants
n=2 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=1 Participants
|
0 Participants
n=1 Participants
|
0 Participants
n=1 Participants
|
0 Participants
n=2 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=1 Participants
|
0 Participants
n=1 Participants
|
0 Participants
n=1 Participants
|
0 Participants
n=2 Participants
|
|
Race (NIH/OMB)
White
|
32 Participants
n=1 Participants
|
35 Participants
n=1 Participants
|
18 Participants
n=1 Participants
|
85 Participants
n=2 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=1 Participants
|
0 Participants
n=1 Participants
|
0 Participants
n=1 Participants
|
0 Participants
n=2 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=1 Participants
|
0 Participants
n=1 Participants
|
0 Participants
n=1 Participants
|
1 Participants
n=2 Participants
|
PRIMARY outcome
Timeframe: Up to approximately 43 monthsPopulation: The analysis population included all participants who received at least one dose of study intervention.
ORR is defined as the percentage of participants with Complete Response (CR: disappearance of all target lesions) or Partial Response (PR: at least a 30% decrease in the sum of diameters of target lesions) per RECIST 1.1. The percentage of participants who experience CR or PR as assessed by BICR is presented.
Outcome measures
| Measure |
Pembrolizumab + MK-4830 + Chemotherapy
n=43 Participants
Participants receive pembrolizumab 200 mg intravenous (IV) infusion on Day 1 of each cycle (cycle length = 3 weeks) every 3 weeks (Q3W) up to 35 administrations (up to approximately 2 years) or until progressive disease (PD) or discontinuation, MK-4830 800 mg IV infusion on Day 1 of each cycle Q3W, up to 35 administrations (up to approximately 2 years) or until PD or discontinuation; etoposide 100 mg/m\^2 IV infusion on Days 1, 2, 3 of each cycle for up to 4 cycles (up to approximately 12 weeks) and cisplatin 75 mg/m\^2 IV infusion or carboplatin AUC 5 mg/ml/min IV infusion (AUC = area under the curve) on Day 1 of each cycle Q3W up to 4 cycles (up to approximately 12 weeks) or until PD or discontinuation.
|
Pembrolizumab + Boserolimab + Chemotherapy
n=41 Participants
Participants receive pembrolizumab 200 mg IV infusion on Day 1 of each cycle Q3W up to 35 administrations (up to approximately 2 years) or until PD or discontinuation, boserolimab 30 mg IV infusion on Day 1 of each cycle (cycle length = 6 weeks) every 6 weeks (Q6W), up to 18 administrations (up to approximately 2 years) or until PD or discontinuation; etoposide 100 mg/m\^2 IV infusion on Days 1, 2, 3 of each cycle for up to 4 cycles (up to approximately 12 weeks) and cisplatin 75 mg/m\^2 IV infusion or carboplatin AUC 5 mg/ml/min IV infusion, Day 1 of each cycle Q3W up to 4 cycles (up to approximately 12 weeks) or until PD or discontinuation.
|
Pembrolizumab + Lenvatinib + Chemotherapy
n=38 Participants
Participants receive pembrolizumab 200 mg IV infusion on Day 1 of each 3 week cycle (Q3W) up to 35 administrations (up to approximately 2 years) or until PD or discontinuation, lenvatinib 8 mg once daily (QD) orally for Cycles 1-4 and up to 20 mg QD orally for Cycles 5-35 or until PD or discontinuation; etoposide 100 mg/m\^2 IV infusion on Days 1, 2, 3 of each cycle for up to 4 cycles (up to approximately 12 weeks) and cisplatin 75 mg/m\^2 IV infusion or carboplatin AUC 5 mg/ml/min IV infusion, Day 1 of each cycle Q3W up to 4 cycles (up to approximately 12 weeks) or until PD or discontinuation.
|
|---|---|---|---|
|
Objective Response Rate (ORR) as Assessed by Blinded Independent Central Review (BICR) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1)
|
65.1 Percentage of participants
Interval 49.1 to 79.0
|
73.2 Percentage of participants
Interval 57.1 to 85.8
|
73.7 Percentage of participants
Interval 56.9 to 86.6
|
PRIMARY outcome
Timeframe: At 6 monthsPopulation: The analysis population included all participants who received at least one dose of study intervention.
Six-month PFS rate is defined as the percentage of participants who have survival without documented progressive disease (PD) per RECIST 1.1 by BICR or death due to any cause, whichever occurs first at 6 months after randomization. PD is defined as ≥20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of ≥5 mm. The appearance of one or more new lesions is also considered PD. PFS rate at 6 months as assessed by BICR is presented.
Outcome measures
| Measure |
Pembrolizumab + MK-4830 + Chemotherapy
n=43 Participants
Participants receive pembrolizumab 200 mg intravenous (IV) infusion on Day 1 of each cycle (cycle length = 3 weeks) every 3 weeks (Q3W) up to 35 administrations (up to approximately 2 years) or until progressive disease (PD) or discontinuation, MK-4830 800 mg IV infusion on Day 1 of each cycle Q3W, up to 35 administrations (up to approximately 2 years) or until PD or discontinuation; etoposide 100 mg/m\^2 IV infusion on Days 1, 2, 3 of each cycle for up to 4 cycles (up to approximately 12 weeks) and cisplatin 75 mg/m\^2 IV infusion or carboplatin AUC 5 mg/ml/min IV infusion (AUC = area under the curve) on Day 1 of each cycle Q3W up to 4 cycles (up to approximately 12 weeks) or until PD or discontinuation.
|
Pembrolizumab + Boserolimab + Chemotherapy
n=41 Participants
Participants receive pembrolizumab 200 mg IV infusion on Day 1 of each cycle Q3W up to 35 administrations (up to approximately 2 years) or until PD or discontinuation, boserolimab 30 mg IV infusion on Day 1 of each cycle (cycle length = 6 weeks) every 6 weeks (Q6W), up to 18 administrations (up to approximately 2 years) or until PD or discontinuation; etoposide 100 mg/m\^2 IV infusion on Days 1, 2, 3 of each cycle for up to 4 cycles (up to approximately 12 weeks) and cisplatin 75 mg/m\^2 IV infusion or carboplatin AUC 5 mg/ml/min IV infusion, Day 1 of each cycle Q3W up to 4 cycles (up to approximately 12 weeks) or until PD or discontinuation.
|
Pembrolizumab + Lenvatinib + Chemotherapy
n=38 Participants
Participants receive pembrolizumab 200 mg IV infusion on Day 1 of each 3 week cycle (Q3W) up to 35 administrations (up to approximately 2 years) or until PD or discontinuation, lenvatinib 8 mg once daily (QD) orally for Cycles 1-4 and up to 20 mg QD orally for Cycles 5-35 or until PD or discontinuation; etoposide 100 mg/m\^2 IV infusion on Days 1, 2, 3 of each cycle for up to 4 cycles (up to approximately 12 weeks) and cisplatin 75 mg/m\^2 IV infusion or carboplatin AUC 5 mg/ml/min IV infusion, Day 1 of each cycle Q3W up to 4 cycles (up to approximately 12 weeks) or until PD or discontinuation.
|
|---|---|---|---|
|
Six-Month Progression-Free Survival (PFS) Rate as Assessed by BICR Per RECIST 1.1
|
45.2 Percentage of Participants
Interval 29.9 to 59.4
|
40.4 Percentage of Participants
Interval 24.9 to 55.3
|
55.9 Percentage of Participants
Interval 37.8 to 70.6
|
SECONDARY outcome
Timeframe: Up to approximately 43 monthsPopulation: The analysis population included all participants who received at least one dose of study intervention and who achieved CR or PR.
For participants who demonstrated a confirmed Complete Response (CR: disappearance of all target lesions) or Partial Response (PR: At least a 30% decrease in the sum of diameters of target lesions) per RECIST 1.1, DOR was defined as the time from first documented evidence of a CR or PR until progressive disease (PD) or death. DOR for participants who had not progressed or died at the time of analysis was to be censored at the date of their last tumor assessment. Per RECIST 1.1, PD was defined as at least a 20% increase in the sum of diameters of target lesions as well as an absolute increase of at least a 5 mm in the sum of diameters. The appearance of one or more new lesions was also considered PD. DOR assessments were based on blinded central imaging review with confirmation. The DOR as assessed using RECIST 1.1 for all participants who experienced a confirmed CR or PR is presented.
Outcome measures
| Measure |
Pembrolizumab + MK-4830 + Chemotherapy
n=28 Participants
Participants receive pembrolizumab 200 mg intravenous (IV) infusion on Day 1 of each cycle (cycle length = 3 weeks) every 3 weeks (Q3W) up to 35 administrations (up to approximately 2 years) or until progressive disease (PD) or discontinuation, MK-4830 800 mg IV infusion on Day 1 of each cycle Q3W, up to 35 administrations (up to approximately 2 years) or until PD or discontinuation; etoposide 100 mg/m\^2 IV infusion on Days 1, 2, 3 of each cycle for up to 4 cycles (up to approximately 12 weeks) and cisplatin 75 mg/m\^2 IV infusion or carboplatin AUC 5 mg/ml/min IV infusion (AUC = area under the curve) on Day 1 of each cycle Q3W up to 4 cycles (up to approximately 12 weeks) or until PD or discontinuation.
|
Pembrolizumab + Boserolimab + Chemotherapy
n=30 Participants
Participants receive pembrolizumab 200 mg IV infusion on Day 1 of each cycle Q3W up to 35 administrations (up to approximately 2 years) or until PD or discontinuation, boserolimab 30 mg IV infusion on Day 1 of each cycle (cycle length = 6 weeks) every 6 weeks (Q6W), up to 18 administrations (up to approximately 2 years) or until PD or discontinuation; etoposide 100 mg/m\^2 IV infusion on Days 1, 2, 3 of each cycle for up to 4 cycles (up to approximately 12 weeks) and cisplatin 75 mg/m\^2 IV infusion or carboplatin AUC 5 mg/ml/min IV infusion, Day 1 of each cycle Q3W up to 4 cycles (up to approximately 12 weeks) or until PD or discontinuation.
|
Pembrolizumab + Lenvatinib + Chemotherapy
n=28 Participants
Participants receive pembrolizumab 200 mg IV infusion on Day 1 of each 3 week cycle (Q3W) up to 35 administrations (up to approximately 2 years) or until PD or discontinuation, lenvatinib 8 mg once daily (QD) orally for Cycles 1-4 and up to 20 mg QD orally for Cycles 5-35 or until PD or discontinuation; etoposide 100 mg/m\^2 IV infusion on Days 1, 2, 3 of each cycle for up to 4 cycles (up to approximately 12 weeks) and cisplatin 75 mg/m\^2 IV infusion or carboplatin AUC 5 mg/ml/min IV infusion, Day 1 of each cycle Q3W up to 4 cycles (up to approximately 12 weeks) or until PD or discontinuation.
|
|---|---|---|---|
|
Duration of Response (DOR) as Assessed by BICR Per RECIST 1.1
|
6.1 Months
Interval 3.9 to 13.9
|
4.7 Months
Interval 4.2 to 7.1
|
7.0 Months
Interval 4.4 to 15.7
|
SECONDARY outcome
Timeframe: Up to approximately 43 monthsPopulation: The analysis population included all participants who received at least one dose of study intervention.
PFS is defined as the time from randomization to the first documented PD per RECIST 1.1 by BICR or death due to any cause, whichever occurs first. PD is defined as ≥20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of ≥5 mm. The appearance of one or more new lesions is also considered PD. PFS as assessed by BICR is presented.
Outcome measures
| Measure |
Pembrolizumab + MK-4830 + Chemotherapy
n=43 Participants
Participants receive pembrolizumab 200 mg intravenous (IV) infusion on Day 1 of each cycle (cycle length = 3 weeks) every 3 weeks (Q3W) up to 35 administrations (up to approximately 2 years) or until progressive disease (PD) or discontinuation, MK-4830 800 mg IV infusion on Day 1 of each cycle Q3W, up to 35 administrations (up to approximately 2 years) or until PD or discontinuation; etoposide 100 mg/m\^2 IV infusion on Days 1, 2, 3 of each cycle for up to 4 cycles (up to approximately 12 weeks) and cisplatin 75 mg/m\^2 IV infusion or carboplatin AUC 5 mg/ml/min IV infusion (AUC = area under the curve) on Day 1 of each cycle Q3W up to 4 cycles (up to approximately 12 weeks) or until PD or discontinuation.
|
Pembrolizumab + Boserolimab + Chemotherapy
n=41 Participants
Participants receive pembrolizumab 200 mg IV infusion on Day 1 of each cycle Q3W up to 35 administrations (up to approximately 2 years) or until PD or discontinuation, boserolimab 30 mg IV infusion on Day 1 of each cycle (cycle length = 6 weeks) every 6 weeks (Q6W), up to 18 administrations (up to approximately 2 years) or until PD or discontinuation; etoposide 100 mg/m\^2 IV infusion on Days 1, 2, 3 of each cycle for up to 4 cycles (up to approximately 12 weeks) and cisplatin 75 mg/m\^2 IV infusion or carboplatin AUC 5 mg/ml/min IV infusion, Day 1 of each cycle Q3W up to 4 cycles (up to approximately 12 weeks) or until PD or discontinuation.
|
Pembrolizumab + Lenvatinib + Chemotherapy
n=38 Participants
Participants receive pembrolizumab 200 mg IV infusion on Day 1 of each 3 week cycle (Q3W) up to 35 administrations (up to approximately 2 years) or until PD or discontinuation, lenvatinib 8 mg once daily (QD) orally for Cycles 1-4 and up to 20 mg QD orally for Cycles 5-35 or until PD or discontinuation; etoposide 100 mg/m\^2 IV infusion on Days 1, 2, 3 of each cycle for up to 4 cycles (up to approximately 12 weeks) and cisplatin 75 mg/m\^2 IV infusion or carboplatin AUC 5 mg/ml/min IV infusion, Day 1 of each cycle Q3W up to 4 cycles (up to approximately 12 weeks) or until PD or discontinuation.
|
|---|---|---|---|
|
Progression-Free Survival (PFS) as Assessed by BICR Per RECIST 1.1
|
5.5 Months
Interval 4.2 to 8.3
|
5.6 Months
Interval 4.2 to 6.7
|
7.5 Months
Interval 5.5 to 12.7
|
SECONDARY outcome
Timeframe: Up to approximately 43 monthsPopulation: The analysis population included all participants who received at least one dose of study intervention.
OS was defined as the time from randomization to death due to any cause. Participants without documented death at the time of the final analysis were to be censored at the date of the last follow-up. The OS for all participants is presented.
Outcome measures
| Measure |
Pembrolizumab + MK-4830 + Chemotherapy
n=43 Participants
Participants receive pembrolizumab 200 mg intravenous (IV) infusion on Day 1 of each cycle (cycle length = 3 weeks) every 3 weeks (Q3W) up to 35 administrations (up to approximately 2 years) or until progressive disease (PD) or discontinuation, MK-4830 800 mg IV infusion on Day 1 of each cycle Q3W, up to 35 administrations (up to approximately 2 years) or until PD or discontinuation; etoposide 100 mg/m\^2 IV infusion on Days 1, 2, 3 of each cycle for up to 4 cycles (up to approximately 12 weeks) and cisplatin 75 mg/m\^2 IV infusion or carboplatin AUC 5 mg/ml/min IV infusion (AUC = area under the curve) on Day 1 of each cycle Q3W up to 4 cycles (up to approximately 12 weeks) or until PD or discontinuation.
|
Pembrolizumab + Boserolimab + Chemotherapy
n=41 Participants
Participants receive pembrolizumab 200 mg IV infusion on Day 1 of each cycle Q3W up to 35 administrations (up to approximately 2 years) or until PD or discontinuation, boserolimab 30 mg IV infusion on Day 1 of each cycle (cycle length = 6 weeks) every 6 weeks (Q6W), up to 18 administrations (up to approximately 2 years) or until PD or discontinuation; etoposide 100 mg/m\^2 IV infusion on Days 1, 2, 3 of each cycle for up to 4 cycles (up to approximately 12 weeks) and cisplatin 75 mg/m\^2 IV infusion or carboplatin AUC 5 mg/ml/min IV infusion, Day 1 of each cycle Q3W up to 4 cycles (up to approximately 12 weeks) or until PD or discontinuation.
|
Pembrolizumab + Lenvatinib + Chemotherapy
n=38 Participants
Participants receive pembrolizumab 200 mg IV infusion on Day 1 of each 3 week cycle (Q3W) up to 35 administrations (up to approximately 2 years) or until PD or discontinuation, lenvatinib 8 mg once daily (QD) orally for Cycles 1-4 and up to 20 mg QD orally for Cycles 5-35 or until PD or discontinuation; etoposide 100 mg/m\^2 IV infusion on Days 1, 2, 3 of each cycle for up to 4 cycles (up to approximately 12 weeks) and cisplatin 75 mg/m\^2 IV infusion or carboplatin AUC 5 mg/ml/min IV infusion, Day 1 of each cycle Q3W up to 4 cycles (up to approximately 12 weeks) or until PD or discontinuation.
|
|---|---|---|---|
|
Overall Survival (OS)
|
18.8 Months
Interval 8.3 to 39.3
|
16.1 Months
Interval 13.3 to 25.4
|
15.9 Months
Interval 7.2 to 24.4
|
SECONDARY outcome
Timeframe: Baseline and up to 43 monthsPopulation: The analysis population included all participants who received at least one dose of study intervention with at least one post-baseline target lesion.
Tumor size change is defined as the best percent change from baseline in the sum of the diameters of the target lesions as assessed by BICR per RECIST 1.1. The mean best percent change from baseline in tumor size as assessed by BICR per RECIST 1.1 is presented.
Outcome measures
| Measure |
Pembrolizumab + MK-4830 + Chemotherapy
n=40 Participants
Participants receive pembrolizumab 200 mg intravenous (IV) infusion on Day 1 of each cycle (cycle length = 3 weeks) every 3 weeks (Q3W) up to 35 administrations (up to approximately 2 years) or until progressive disease (PD) or discontinuation, MK-4830 800 mg IV infusion on Day 1 of each cycle Q3W, up to 35 administrations (up to approximately 2 years) or until PD or discontinuation; etoposide 100 mg/m\^2 IV infusion on Days 1, 2, 3 of each cycle for up to 4 cycles (up to approximately 12 weeks) and cisplatin 75 mg/m\^2 IV infusion or carboplatin AUC 5 mg/ml/min IV infusion (AUC = area under the curve) on Day 1 of each cycle Q3W up to 4 cycles (up to approximately 12 weeks) or until PD or discontinuation.
|
Pembrolizumab + Boserolimab + Chemotherapy
n=39 Participants
Participants receive pembrolizumab 200 mg IV infusion on Day 1 of each cycle Q3W up to 35 administrations (up to approximately 2 years) or until PD or discontinuation, boserolimab 30 mg IV infusion on Day 1 of each cycle (cycle length = 6 weeks) every 6 weeks (Q6W), up to 18 administrations (up to approximately 2 years) or until PD or discontinuation; etoposide 100 mg/m\^2 IV infusion on Days 1, 2, 3 of each cycle for up to 4 cycles (up to approximately 12 weeks) and cisplatin 75 mg/m\^2 IV infusion or carboplatin AUC 5 mg/ml/min IV infusion, Day 1 of each cycle Q3W up to 4 cycles (up to approximately 12 weeks) or until PD or discontinuation.
|
Pembrolizumab + Lenvatinib + Chemotherapy
n=33 Participants
Participants receive pembrolizumab 200 mg IV infusion on Day 1 of each 3 week cycle (Q3W) up to 35 administrations (up to approximately 2 years) or until PD or discontinuation, lenvatinib 8 mg once daily (QD) orally for Cycles 1-4 and up to 20 mg QD orally for Cycles 5-35 or until PD or discontinuation; etoposide 100 mg/m\^2 IV infusion on Days 1, 2, 3 of each cycle for up to 4 cycles (up to approximately 12 weeks) and cisplatin 75 mg/m\^2 IV infusion or carboplatin AUC 5 mg/ml/min IV infusion, Day 1 of each cycle Q3W up to 4 cycles (up to approximately 12 weeks) or until PD or discontinuation.
|
|---|---|---|---|
|
Mean Percent Change From Baseline in Tumor Size as Assessed by BICR Per RECIST 1.1
|
-57.9 Percent change
Standard Deviation 24.9
|
-54.9 Percent change
Standard Deviation 25.1
|
-61.6 Percent change
Standard Deviation 19.2
|
SECONDARY outcome
Timeframe: Up to approximately 43 monthsPopulation: The analysis population included all participants who received at least one dose of study intervention.
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention. The number of participants who experience an AE is presented.
Outcome measures
| Measure |
Pembrolizumab + MK-4830 + Chemotherapy
n=43 Participants
Participants receive pembrolizumab 200 mg intravenous (IV) infusion on Day 1 of each cycle (cycle length = 3 weeks) every 3 weeks (Q3W) up to 35 administrations (up to approximately 2 years) or until progressive disease (PD) or discontinuation, MK-4830 800 mg IV infusion on Day 1 of each cycle Q3W, up to 35 administrations (up to approximately 2 years) or until PD or discontinuation; etoposide 100 mg/m\^2 IV infusion on Days 1, 2, 3 of each cycle for up to 4 cycles (up to approximately 12 weeks) and cisplatin 75 mg/m\^2 IV infusion or carboplatin AUC 5 mg/ml/min IV infusion (AUC = area under the curve) on Day 1 of each cycle Q3W up to 4 cycles (up to approximately 12 weeks) or until PD or discontinuation.
|
Pembrolizumab + Boserolimab + Chemotherapy
n=41 Participants
Participants receive pembrolizumab 200 mg IV infusion on Day 1 of each cycle Q3W up to 35 administrations (up to approximately 2 years) or until PD or discontinuation, boserolimab 30 mg IV infusion on Day 1 of each cycle (cycle length = 6 weeks) every 6 weeks (Q6W), up to 18 administrations (up to approximately 2 years) or until PD or discontinuation; etoposide 100 mg/m\^2 IV infusion on Days 1, 2, 3 of each cycle for up to 4 cycles (up to approximately 12 weeks) and cisplatin 75 mg/m\^2 IV infusion or carboplatin AUC 5 mg/ml/min IV infusion, Day 1 of each cycle Q3W up to 4 cycles (up to approximately 12 weeks) or until PD or discontinuation.
|
Pembrolizumab + Lenvatinib + Chemotherapy
n=38 Participants
Participants receive pembrolizumab 200 mg IV infusion on Day 1 of each 3 week cycle (Q3W) up to 35 administrations (up to approximately 2 years) or until PD or discontinuation, lenvatinib 8 mg once daily (QD) orally for Cycles 1-4 and up to 20 mg QD orally for Cycles 5-35 or until PD or discontinuation; etoposide 100 mg/m\^2 IV infusion on Days 1, 2, 3 of each cycle for up to 4 cycles (up to approximately 12 weeks) and cisplatin 75 mg/m\^2 IV infusion or carboplatin AUC 5 mg/ml/min IV infusion, Day 1 of each cycle Q3W up to 4 cycles (up to approximately 12 weeks) or until PD or discontinuation.
|
|---|---|---|---|
|
Number of Participants Who Experienced an Adverse Event (AE)
|
42 Participants
|
41 Participants
|
38 Participants
|
SECONDARY outcome
Timeframe: Up to approximately 22 monthsPopulation: The analysis population included all participants who received at least one dose of study intervention.
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention. The number of participants who discontinue study treatment due to an AE is presented.
Outcome measures
| Measure |
Pembrolizumab + MK-4830 + Chemotherapy
n=43 Participants
Participants receive pembrolizumab 200 mg intravenous (IV) infusion on Day 1 of each cycle (cycle length = 3 weeks) every 3 weeks (Q3W) up to 35 administrations (up to approximately 2 years) or until progressive disease (PD) or discontinuation, MK-4830 800 mg IV infusion on Day 1 of each cycle Q3W, up to 35 administrations (up to approximately 2 years) or until PD or discontinuation; etoposide 100 mg/m\^2 IV infusion on Days 1, 2, 3 of each cycle for up to 4 cycles (up to approximately 12 weeks) and cisplatin 75 mg/m\^2 IV infusion or carboplatin AUC 5 mg/ml/min IV infusion (AUC = area under the curve) on Day 1 of each cycle Q3W up to 4 cycles (up to approximately 12 weeks) or until PD or discontinuation.
|
Pembrolizumab + Boserolimab + Chemotherapy
n=41 Participants
Participants receive pembrolizumab 200 mg IV infusion on Day 1 of each cycle Q3W up to 35 administrations (up to approximately 2 years) or until PD or discontinuation, boserolimab 30 mg IV infusion on Day 1 of each cycle (cycle length = 6 weeks) every 6 weeks (Q6W), up to 18 administrations (up to approximately 2 years) or until PD or discontinuation; etoposide 100 mg/m\^2 IV infusion on Days 1, 2, 3 of each cycle for up to 4 cycles (up to approximately 12 weeks) and cisplatin 75 mg/m\^2 IV infusion or carboplatin AUC 5 mg/ml/min IV infusion, Day 1 of each cycle Q3W up to 4 cycles (up to approximately 12 weeks) or until PD or discontinuation.
|
Pembrolizumab + Lenvatinib + Chemotherapy
n=38 Participants
Participants receive pembrolizumab 200 mg IV infusion on Day 1 of each 3 week cycle (Q3W) up to 35 administrations (up to approximately 2 years) or until PD or discontinuation, lenvatinib 8 mg once daily (QD) orally for Cycles 1-4 and up to 20 mg QD orally for Cycles 5-35 or until PD or discontinuation; etoposide 100 mg/m\^2 IV infusion on Days 1, 2, 3 of each cycle for up to 4 cycles (up to approximately 12 weeks) and cisplatin 75 mg/m\^2 IV infusion or carboplatin AUC 5 mg/ml/min IV infusion, Day 1 of each cycle Q3W up to 4 cycles (up to approximately 12 weeks) or until PD or discontinuation.
|
|---|---|---|---|
|
Number of Participants Who Discontinued Study Treatment Due to an AE
|
5 Participants
|
9 Participants
|
21 Participants
|
SECONDARY outcome
Timeframe: Baseline, Week 19Population: The analysis population included all randomized participants who received at least one dose of study intervention and who had patient reported outcome (PRO) assessments available at both baseline and the specified post baseline for the specific endpoint.
The EORTC QLQ-C30 is a questionnaire to assess the overall quality of life of cancer patients. Participant responses to the questions "How would you rate your overall health during the past week?" and "How would you rate your overall quality of life during the past week?" are scored on a 7-point scale (1= Very poor to 7=Excellent). Using linear transformation, raw scores are standardized so that the total score ranges from 0 to 100 for the combined scores. A higher score indicates a better overall health status. The change from baseline in EORTC QLQ-C30 Items 29 and 30 combined score is presented.
Outcome measures
| Measure |
Pembrolizumab + MK-4830 + Chemotherapy
n=43 Participants
Participants receive pembrolizumab 200 mg intravenous (IV) infusion on Day 1 of each cycle (cycle length = 3 weeks) every 3 weeks (Q3W) up to 35 administrations (up to approximately 2 years) or until progressive disease (PD) or discontinuation, MK-4830 800 mg IV infusion on Day 1 of each cycle Q3W, up to 35 administrations (up to approximately 2 years) or until PD or discontinuation; etoposide 100 mg/m\^2 IV infusion on Days 1, 2, 3 of each cycle for up to 4 cycles (up to approximately 12 weeks) and cisplatin 75 mg/m\^2 IV infusion or carboplatin AUC 5 mg/ml/min IV infusion (AUC = area under the curve) on Day 1 of each cycle Q3W up to 4 cycles (up to approximately 12 weeks) or until PD or discontinuation.
|
Pembrolizumab + Boserolimab + Chemotherapy
n=41 Participants
Participants receive pembrolizumab 200 mg IV infusion on Day 1 of each cycle Q3W up to 35 administrations (up to approximately 2 years) or until PD or discontinuation, boserolimab 30 mg IV infusion on Day 1 of each cycle (cycle length = 6 weeks) every 6 weeks (Q6W), up to 18 administrations (up to approximately 2 years) or until PD or discontinuation; etoposide 100 mg/m\^2 IV infusion on Days 1, 2, 3 of each cycle for up to 4 cycles (up to approximately 12 weeks) and cisplatin 75 mg/m\^2 IV infusion or carboplatin AUC 5 mg/ml/min IV infusion, Day 1 of each cycle Q3W up to 4 cycles (up to approximately 12 weeks) or until PD or discontinuation.
|
Pembrolizumab + Lenvatinib + Chemotherapy
n=38 Participants
Participants receive pembrolizumab 200 mg IV infusion on Day 1 of each 3 week cycle (Q3W) up to 35 administrations (up to approximately 2 years) or until PD or discontinuation, lenvatinib 8 mg once daily (QD) orally for Cycles 1-4 and up to 20 mg QD orally for Cycles 5-35 or until PD or discontinuation; etoposide 100 mg/m\^2 IV infusion on Days 1, 2, 3 of each cycle for up to 4 cycles (up to approximately 12 weeks) and cisplatin 75 mg/m\^2 IV infusion or carboplatin AUC 5 mg/ml/min IV infusion, Day 1 of each cycle Q3W up to 4 cycles (up to approximately 12 weeks) or until PD or discontinuation.
|
|---|---|---|---|
|
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) Global Health Status (Item 29) and Quality of Life (Item 30) Combined Score
|
4.85 Scores on a scale
Interval -2.62 to 12.32
|
1.73 Scores on a scale
Interval -5.73 to 9.19
|
-0.09 Scores on a scale
Interval -7.86 to 7.69
|
Adverse Events
MK-4830 + Pembrolizumab + Etoposide/Platinum
Serious events: 13 serious events
Other events: 41 other events
Deaths: 28 deaths
MK-5890 + Pembrolizumab +Etoposide/Platinum
Serious events: 16 serious events
Other events: 41 other events
Deaths: 31 deaths
Lenvatinib +Pembrolizumab + Etoposide/Platinum
Serious events: 25 serious events
Other events: 38 other events
Deaths: 28 deaths
Serious adverse events
| Measure |
MK-4830 + Pembrolizumab + Etoposide/Platinum
n=43 participants at risk
Participants receive pembrolizumab 200 mg IV infusion on Day 1 of each cycle (cycle length = 3 weeks) every 3 weeks (Q3W) up to 35 administrations (up to approximately 2 years) or until disease progression (PD) or discontinuation, MK-4830 800 mg IV infusion on Day 1 of each cycle Q3W, up to 35 administrations (up to approximately 2 years) or until PD or discontinuation; etoposide 100 mg/m\^2 on Days 1, 2, 3 of each cycle for up to 4 cycles (up to approximately 12 weeks) and cisplatin 75 mg/m\^2 or carboplatin AUC 5 mg/ml/min IV, Day 1 of each cycle Q3W up to 4 cycles (up to approximately 12 weeks) or until PD or discontinuation.
|
MK-5890 + Pembrolizumab +Etoposide/Platinum
n=41 participants at risk
Participants receive pembrolizumab 200 mg IV infusion on Day 1 of each cycle Q3W up to 35 administrations (up to approximately 2 years) or until PD or discontinuation, boserolimab 30 mg IV infusion on Day 1 of each cycle (cycle length = 6 weeks) every 6 weeks (Q6W), up to 18 administrations (up to approximately 2 years) or until PD or discontinuation; etoposide 100 mg/m\^2 on Days 1, 2, 3 of each cycle for up to 4 cycles (up to approximately 12 weeks) and cisplatin 75 mg/m\^2 or carboplatin AUC 5 mg/ml/min IV, Day 1 of each cycle Q3W up to 4 cycles (up to approximately 12 weeks) or until PD or discontinuation.
|
Lenvatinib +Pembrolizumab + Etoposide/Platinum
n=38 participants at risk
Participants receive pembrolizumab 200 mg IV infusion on Day 1 of each 3 week cycle (Q3W) up to 35 administrations (up to approximately 2 years) or until PD or discontinuation, lenvatinib 8 mg once daily (QD) orally up to Cycles 1-4 cycles and up to 20 mg QD orally for Cycles 5-31 or until PD or discontinuation; etoposide 100 mg/m\^2 on Days 1, 2, 3 of each cycle for up to 4 cycles (up to approximately 12 weeks) and cisplatin 75 mg/m\^2 or carboplatin AUC 5 mg/ml/min IV, Day 1 of each cycle Q3W up to 4 cycles (up to approximately 12 weeks) or until PD or discontinuation.
|
|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
2.3%
1/43 • Number of events 1 • Up to approximately 43 months
Serious and Other adverse events (AEs) included all participants who received ≥1 dose of study drug. All-Cause Mortality included all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment were excluded as AEs. Data are reported by treatment received.
|
0.00%
0/41 • Up to approximately 43 months
Serious and Other adverse events (AEs) included all participants who received ≥1 dose of study drug. All-Cause Mortality included all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment were excluded as AEs. Data are reported by treatment received.
|
0.00%
0/38 • Up to approximately 43 months
Serious and Other adverse events (AEs) included all participants who received ≥1 dose of study drug. All-Cause Mortality included all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment were excluded as AEs. Data are reported by treatment received.
|
|
Blood and lymphatic system disorders
Aplastic anaemia
|
0.00%
0/43 • Up to approximately 43 months
Serious and Other adverse events (AEs) included all participants who received ≥1 dose of study drug. All-Cause Mortality included all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment were excluded as AEs. Data are reported by treatment received.
|
0.00%
0/41 • Up to approximately 43 months
Serious and Other adverse events (AEs) included all participants who received ≥1 dose of study drug. All-Cause Mortality included all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment were excluded as AEs. Data are reported by treatment received.
|
2.6%
1/38 • Number of events 1 • Up to approximately 43 months
Serious and Other adverse events (AEs) included all participants who received ≥1 dose of study drug. All-Cause Mortality included all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment were excluded as AEs. Data are reported by treatment received.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
2.3%
1/43 • Number of events 1 • Up to approximately 43 months
Serious and Other adverse events (AEs) included all participants who received ≥1 dose of study drug. All-Cause Mortality included all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment were excluded as AEs. Data are reported by treatment received.
|
2.4%
1/41 • Number of events 1 • Up to approximately 43 months
Serious and Other adverse events (AEs) included all participants who received ≥1 dose of study drug. All-Cause Mortality included all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment were excluded as AEs. Data are reported by treatment received.
|
7.9%
3/38 • Number of events 3 • Up to approximately 43 months
Serious and Other adverse events (AEs) included all participants who received ≥1 dose of study drug. All-Cause Mortality included all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment were excluded as AEs. Data are reported by treatment received.
|
|
Blood and lymphatic system disorders
Leukopenia
|
2.3%
1/43 • Number of events 1 • Up to approximately 43 months
Serious and Other adverse events (AEs) included all participants who received ≥1 dose of study drug. All-Cause Mortality included all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment were excluded as AEs. Data are reported by treatment received.
|
0.00%
0/41 • Up to approximately 43 months
Serious and Other adverse events (AEs) included all participants who received ≥1 dose of study drug. All-Cause Mortality included all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment were excluded as AEs. Data are reported by treatment received.
|
0.00%
0/38 • Up to approximately 43 months
Serious and Other adverse events (AEs) included all participants who received ≥1 dose of study drug. All-Cause Mortality included all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment were excluded as AEs. Data are reported by treatment received.
|
|
Blood and lymphatic system disorders
Neutropenia
|
2.3%
1/43 • Number of events 1 • Up to approximately 43 months
Serious and Other adverse events (AEs) included all participants who received ≥1 dose of study drug. All-Cause Mortality included all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment were excluded as AEs. Data are reported by treatment received.
|
4.9%
2/41 • Number of events 2 • Up to approximately 43 months
Serious and Other adverse events (AEs) included all participants who received ≥1 dose of study drug. All-Cause Mortality included all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment were excluded as AEs. Data are reported by treatment received.
|
5.3%
2/38 • Number of events 2 • Up to approximately 43 months
Serious and Other adverse events (AEs) included all participants who received ≥1 dose of study drug. All-Cause Mortality included all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment were excluded as AEs. Data are reported by treatment received.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
2.3%
1/43 • Number of events 1 • Up to approximately 43 months
Serious and Other adverse events (AEs) included all participants who received ≥1 dose of study drug. All-Cause Mortality included all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment were excluded as AEs. Data are reported by treatment received.
|
0.00%
0/41 • Up to approximately 43 months
Serious and Other adverse events (AEs) included all participants who received ≥1 dose of study drug. All-Cause Mortality included all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment were excluded as AEs. Data are reported by treatment received.
|
0.00%
0/38 • Up to approximately 43 months
Serious and Other adverse events (AEs) included all participants who received ≥1 dose of study drug. All-Cause Mortality included all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment were excluded as AEs. Data are reported by treatment received.
|
|
Cardiac disorders
Acute myocardial infarction
|
2.3%
1/43 • Number of events 1 • Up to approximately 43 months
Serious and Other adverse events (AEs) included all participants who received ≥1 dose of study drug. All-Cause Mortality included all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment were excluded as AEs. Data are reported by treatment received.
|
0.00%
0/41 • Up to approximately 43 months
Serious and Other adverse events (AEs) included all participants who received ≥1 dose of study drug. All-Cause Mortality included all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment were excluded as AEs. Data are reported by treatment received.
|
0.00%
0/38 • Up to approximately 43 months
Serious and Other adverse events (AEs) included all participants who received ≥1 dose of study drug. All-Cause Mortality included all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment were excluded as AEs. Data are reported by treatment received.
|
|
Cardiac disorders
Atrial flutter
|
0.00%
0/43 • Up to approximately 43 months
Serious and Other adverse events (AEs) included all participants who received ≥1 dose of study drug. All-Cause Mortality included all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment were excluded as AEs. Data are reported by treatment received.
|
0.00%
0/41 • Up to approximately 43 months
Serious and Other adverse events (AEs) included all participants who received ≥1 dose of study drug. All-Cause Mortality included all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment were excluded as AEs. Data are reported by treatment received.
|
2.6%
1/38 • Number of events 1 • Up to approximately 43 months
Serious and Other adverse events (AEs) included all participants who received ≥1 dose of study drug. All-Cause Mortality included all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment were excluded as AEs. Data are reported by treatment received.
|
|
Cardiac disorders
Cardiac arrest
|
0.00%
0/43 • Up to approximately 43 months
Serious and Other adverse events (AEs) included all participants who received ≥1 dose of study drug. All-Cause Mortality included all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment were excluded as AEs. Data are reported by treatment received.
|
0.00%
0/41 • Up to approximately 43 months
Serious and Other adverse events (AEs) included all participants who received ≥1 dose of study drug. All-Cause Mortality included all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment were excluded as AEs. Data are reported by treatment received.
|
2.6%
1/38 • Number of events 1 • Up to approximately 43 months
Serious and Other adverse events (AEs) included all participants who received ≥1 dose of study drug. All-Cause Mortality included all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment were excluded as AEs. Data are reported by treatment received.
|
|
Cardiac disorders
Ventricular tachycardia
|
2.3%
1/43 • Number of events 1 • Up to approximately 43 months
Serious and Other adverse events (AEs) included all participants who received ≥1 dose of study drug. All-Cause Mortality included all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment were excluded as AEs. Data are reported by treatment received.
|
0.00%
0/41 • Up to approximately 43 months
Serious and Other adverse events (AEs) included all participants who received ≥1 dose of study drug. All-Cause Mortality included all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment were excluded as AEs. Data are reported by treatment received.
|
0.00%
0/38 • Up to approximately 43 months
Serious and Other adverse events (AEs) included all participants who received ≥1 dose of study drug. All-Cause Mortality included all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment were excluded as AEs. Data are reported by treatment received.
|
|
Endocrine disorders
Adrenal insufficiency
|
0.00%
0/43 • Up to approximately 43 months
Serious and Other adverse events (AEs) included all participants who received ≥1 dose of study drug. All-Cause Mortality included all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment were excluded as AEs. Data are reported by treatment received.
|
0.00%
0/41 • Up to approximately 43 months
Serious and Other adverse events (AEs) included all participants who received ≥1 dose of study drug. All-Cause Mortality included all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment were excluded as AEs. Data are reported by treatment received.
|
2.6%
1/38 • Number of events 1 • Up to approximately 43 months
Serious and Other adverse events (AEs) included all participants who received ≥1 dose of study drug. All-Cause Mortality included all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment were excluded as AEs. Data are reported by treatment received.
|
|
Endocrine disorders
Inappropriate antidiuretic hormone secretion
|
2.3%
1/43 • Number of events 1 • Up to approximately 43 months
Serious and Other adverse events (AEs) included all participants who received ≥1 dose of study drug. All-Cause Mortality included all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment were excluded as AEs. Data are reported by treatment received.
|
2.4%
1/41 • Number of events 2 • Up to approximately 43 months
Serious and Other adverse events (AEs) included all participants who received ≥1 dose of study drug. All-Cause Mortality included all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment were excluded as AEs. Data are reported by treatment received.
|
0.00%
0/38 • Up to approximately 43 months
Serious and Other adverse events (AEs) included all participants who received ≥1 dose of study drug. All-Cause Mortality included all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment were excluded as AEs. Data are reported by treatment received.
|
|
Gastrointestinal disorders
Colitis
|
0.00%
0/43 • Up to approximately 43 months
Serious and Other adverse events (AEs) included all participants who received ≥1 dose of study drug. All-Cause Mortality included all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment were excluded as AEs. Data are reported by treatment received.
|
0.00%
0/41 • Up to approximately 43 months
Serious and Other adverse events (AEs) included all participants who received ≥1 dose of study drug. All-Cause Mortality included all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment were excluded as AEs. Data are reported by treatment received.
|
2.6%
1/38 • Number of events 1 • Up to approximately 43 months
Serious and Other adverse events (AEs) included all participants who received ≥1 dose of study drug. All-Cause Mortality included all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment were excluded as AEs. Data are reported by treatment received.
|
|
Gastrointestinal disorders
Immune-mediated pancreatitis
|
0.00%
0/43 • Up to approximately 43 months
Serious and Other adverse events (AEs) included all participants who received ≥1 dose of study drug. All-Cause Mortality included all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment were excluded as AEs. Data are reported by treatment received.
|
2.4%
1/41 • Number of events 1 • Up to approximately 43 months
Serious and Other adverse events (AEs) included all participants who received ≥1 dose of study drug. All-Cause Mortality included all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment were excluded as AEs. Data are reported by treatment received.
|
0.00%
0/38 • Up to approximately 43 months
Serious and Other adverse events (AEs) included all participants who received ≥1 dose of study drug. All-Cause Mortality included all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment were excluded as AEs. Data are reported by treatment received.
|
|
Gastrointestinal disorders
Intestinal ischaemia
|
0.00%
0/43 • Up to approximately 43 months
Serious and Other adverse events (AEs) included all participants who received ≥1 dose of study drug. All-Cause Mortality included all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment were excluded as AEs. Data are reported by treatment received.
|
0.00%
0/41 • Up to approximately 43 months
Serious and Other adverse events (AEs) included all participants who received ≥1 dose of study drug. All-Cause Mortality included all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment were excluded as AEs. Data are reported by treatment received.
|
2.6%
1/38 • Number of events 1 • Up to approximately 43 months
Serious and Other adverse events (AEs) included all participants who received ≥1 dose of study drug. All-Cause Mortality included all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment were excluded as AEs. Data are reported by treatment received.
|
|
Gastrointestinal disorders
Intestinal obstruction
|
2.3%
1/43 • Number of events 1 • Up to approximately 43 months
Serious and Other adverse events (AEs) included all participants who received ≥1 dose of study drug. All-Cause Mortality included all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment were excluded as AEs. Data are reported by treatment received.
|
0.00%
0/41 • Up to approximately 43 months
Serious and Other adverse events (AEs) included all participants who received ≥1 dose of study drug. All-Cause Mortality included all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment were excluded as AEs. Data are reported by treatment received.
|
0.00%
0/38 • Up to approximately 43 months
Serious and Other adverse events (AEs) included all participants who received ≥1 dose of study drug. All-Cause Mortality included all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment were excluded as AEs. Data are reported by treatment received.
|
|
Gastrointestinal disorders
Lower gastrointestinal haemorrhage
|
0.00%
0/43 • Up to approximately 43 months
Serious and Other adverse events (AEs) included all participants who received ≥1 dose of study drug. All-Cause Mortality included all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment were excluded as AEs. Data are reported by treatment received.
|
0.00%
0/41 • Up to approximately 43 months
Serious and Other adverse events (AEs) included all participants who received ≥1 dose of study drug. All-Cause Mortality included all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment were excluded as AEs. Data are reported by treatment received.
|
2.6%
1/38 • Number of events 1 • Up to approximately 43 months
Serious and Other adverse events (AEs) included all participants who received ≥1 dose of study drug. All-Cause Mortality included all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment were excluded as AEs. Data are reported by treatment received.
|
|
General disorders
Death
|
0.00%
0/43 • Up to approximately 43 months
Serious and Other adverse events (AEs) included all participants who received ≥1 dose of study drug. All-Cause Mortality included all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment were excluded as AEs. Data are reported by treatment received.
|
0.00%
0/41 • Up to approximately 43 months
Serious and Other adverse events (AEs) included all participants who received ≥1 dose of study drug. All-Cause Mortality included all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment were excluded as AEs. Data are reported by treatment received.
|
5.3%
2/38 • Number of events 2 • Up to approximately 43 months
Serious and Other adverse events (AEs) included all participants who received ≥1 dose of study drug. All-Cause Mortality included all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment were excluded as AEs. Data are reported by treatment received.
|
|
General disorders
Fatigue
|
0.00%
0/43 • Up to approximately 43 months
Serious and Other adverse events (AEs) included all participants who received ≥1 dose of study drug. All-Cause Mortality included all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment were excluded as AEs. Data are reported by treatment received.
|
2.4%
1/41 • Number of events 1 • Up to approximately 43 months
Serious and Other adverse events (AEs) included all participants who received ≥1 dose of study drug. All-Cause Mortality included all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment were excluded as AEs. Data are reported by treatment received.
|
5.3%
2/38 • Number of events 2 • Up to approximately 43 months
Serious and Other adverse events (AEs) included all participants who received ≥1 dose of study drug. All-Cause Mortality included all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment were excluded as AEs. Data are reported by treatment received.
|
|
General disorders
Impaired healing
|
2.3%
1/43 • Number of events 1 • Up to approximately 43 months
Serious and Other adverse events (AEs) included all participants who received ≥1 dose of study drug. All-Cause Mortality included all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment were excluded as AEs. Data are reported by treatment received.
|
0.00%
0/41 • Up to approximately 43 months
Serious and Other adverse events (AEs) included all participants who received ≥1 dose of study drug. All-Cause Mortality included all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment were excluded as AEs. Data are reported by treatment received.
|
0.00%
0/38 • Up to approximately 43 months
Serious and Other adverse events (AEs) included all participants who received ≥1 dose of study drug. All-Cause Mortality included all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment were excluded as AEs. Data are reported by treatment received.
|
|
General disorders
Pain
|
2.3%
1/43 • Number of events 1 • Up to approximately 43 months
Serious and Other adverse events (AEs) included all participants who received ≥1 dose of study drug. All-Cause Mortality included all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment were excluded as AEs. Data are reported by treatment received.
|
0.00%
0/41 • Up to approximately 43 months
Serious and Other adverse events (AEs) included all participants who received ≥1 dose of study drug. All-Cause Mortality included all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment were excluded as AEs. Data are reported by treatment received.
|
0.00%
0/38 • Up to approximately 43 months
Serious and Other adverse events (AEs) included all participants who received ≥1 dose of study drug. All-Cause Mortality included all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment were excluded as AEs. Data are reported by treatment received.
|
|
General disorders
Pyrexia
|
0.00%
0/43 • Up to approximately 43 months
Serious and Other adverse events (AEs) included all participants who received ≥1 dose of study drug. All-Cause Mortality included all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment were excluded as AEs. Data are reported by treatment received.
|
2.4%
1/41 • Number of events 1 • Up to approximately 43 months
Serious and Other adverse events (AEs) included all participants who received ≥1 dose of study drug. All-Cause Mortality included all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment were excluded as AEs. Data are reported by treatment received.
|
0.00%
0/38 • Up to approximately 43 months
Serious and Other adverse events (AEs) included all participants who received ≥1 dose of study drug. All-Cause Mortality included all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment were excluded as AEs. Data are reported by treatment received.
|
|
Hepatobiliary disorders
Cholangitis
|
0.00%
0/43 • Up to approximately 43 months
Serious and Other adverse events (AEs) included all participants who received ≥1 dose of study drug. All-Cause Mortality included all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment were excluded as AEs. Data are reported by treatment received.
|
0.00%
0/41 • Up to approximately 43 months
Serious and Other adverse events (AEs) included all participants who received ≥1 dose of study drug. All-Cause Mortality included all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment were excluded as AEs. Data are reported by treatment received.
|
2.6%
1/38 • Number of events 2 • Up to approximately 43 months
Serious and Other adverse events (AEs) included all participants who received ≥1 dose of study drug. All-Cause Mortality included all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment were excluded as AEs. Data are reported by treatment received.
|
|
Hepatobiliary disorders
Immune-mediated cholangitis
|
0.00%
0/43 • Up to approximately 43 months
Serious and Other adverse events (AEs) included all participants who received ≥1 dose of study drug. All-Cause Mortality included all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment were excluded as AEs. Data are reported by treatment received.
|
0.00%
0/41 • Up to approximately 43 months
Serious and Other adverse events (AEs) included all participants who received ≥1 dose of study drug. All-Cause Mortality included all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment were excluded as AEs. Data are reported by treatment received.
|
2.6%
1/38 • Number of events 1 • Up to approximately 43 months
Serious and Other adverse events (AEs) included all participants who received ≥1 dose of study drug. All-Cause Mortality included all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment were excluded as AEs. Data are reported by treatment received.
|
|
Infections and infestations
Anorectal infection
|
0.00%
0/43 • Up to approximately 43 months
Serious and Other adverse events (AEs) included all participants who received ≥1 dose of study drug. All-Cause Mortality included all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment were excluded as AEs. Data are reported by treatment received.
|
0.00%
0/41 • Up to approximately 43 months
Serious and Other adverse events (AEs) included all participants who received ≥1 dose of study drug. All-Cause Mortality included all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment were excluded as AEs. Data are reported by treatment received.
|
2.6%
1/38 • Number of events 1 • Up to approximately 43 months
Serious and Other adverse events (AEs) included all participants who received ≥1 dose of study drug. All-Cause Mortality included all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment were excluded as AEs. Data are reported by treatment received.
|
|
Infections and infestations
COVID-19
|
0.00%
0/43 • Up to approximately 43 months
Serious and Other adverse events (AEs) included all participants who received ≥1 dose of study drug. All-Cause Mortality included all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment were excluded as AEs. Data are reported by treatment received.
|
2.4%
1/41 • Number of events 1 • Up to approximately 43 months
Serious and Other adverse events (AEs) included all participants who received ≥1 dose of study drug. All-Cause Mortality included all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment were excluded as AEs. Data are reported by treatment received.
|
5.3%
2/38 • Number of events 2 • Up to approximately 43 months
Serious and Other adverse events (AEs) included all participants who received ≥1 dose of study drug. All-Cause Mortality included all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment were excluded as AEs. Data are reported by treatment received.
|
|
Infections and infestations
COVID-19 pneumonia
|
0.00%
0/43 • Up to approximately 43 months
Serious and Other adverse events (AEs) included all participants who received ≥1 dose of study drug. All-Cause Mortality included all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment were excluded as AEs. Data are reported by treatment received.
|
2.4%
1/41 • Number of events 1 • Up to approximately 43 months
Serious and Other adverse events (AEs) included all participants who received ≥1 dose of study drug. All-Cause Mortality included all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment were excluded as AEs. Data are reported by treatment received.
|
0.00%
0/38 • Up to approximately 43 months
Serious and Other adverse events (AEs) included all participants who received ≥1 dose of study drug. All-Cause Mortality included all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment were excluded as AEs. Data are reported by treatment received.
|
|
Infections and infestations
Candida infection
|
0.00%
0/43 • Up to approximately 43 months
Serious and Other adverse events (AEs) included all participants who received ≥1 dose of study drug. All-Cause Mortality included all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment were excluded as AEs. Data are reported by treatment received.
|
0.00%
0/41 • Up to approximately 43 months
Serious and Other adverse events (AEs) included all participants who received ≥1 dose of study drug. All-Cause Mortality included all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment were excluded as AEs. Data are reported by treatment received.
|
2.6%
1/38 • Number of events 1 • Up to approximately 43 months
Serious and Other adverse events (AEs) included all participants who received ≥1 dose of study drug. All-Cause Mortality included all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment were excluded as AEs. Data are reported by treatment received.
|
|
Infections and infestations
Device related infection
|
0.00%
0/43 • Up to approximately 43 months
Serious and Other adverse events (AEs) included all participants who received ≥1 dose of study drug. All-Cause Mortality included all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment were excluded as AEs. Data are reported by treatment received.
|
0.00%
0/41 • Up to approximately 43 months
Serious and Other adverse events (AEs) included all participants who received ≥1 dose of study drug. All-Cause Mortality included all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment were excluded as AEs. Data are reported by treatment received.
|
2.6%
1/38 • Number of events 1 • Up to approximately 43 months
Serious and Other adverse events (AEs) included all participants who received ≥1 dose of study drug. All-Cause Mortality included all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment were excluded as AEs. Data are reported by treatment received.
|
|
Infections and infestations
Oral herpes
|
2.3%
1/43 • Number of events 1 • Up to approximately 43 months
Serious and Other adverse events (AEs) included all participants who received ≥1 dose of study drug. All-Cause Mortality included all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment were excluded as AEs. Data are reported by treatment received.
|
0.00%
0/41 • Up to approximately 43 months
Serious and Other adverse events (AEs) included all participants who received ≥1 dose of study drug. All-Cause Mortality included all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment were excluded as AEs. Data are reported by treatment received.
|
0.00%
0/38 • Up to approximately 43 months
Serious and Other adverse events (AEs) included all participants who received ≥1 dose of study drug. All-Cause Mortality included all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment were excluded as AEs. Data are reported by treatment received.
|
|
Infections and infestations
Periorbital cellulitis
|
2.3%
1/43 • Number of events 1 • Up to approximately 43 months
Serious and Other adverse events (AEs) included all participants who received ≥1 dose of study drug. All-Cause Mortality included all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment were excluded as AEs. Data are reported by treatment received.
|
0.00%
0/41 • Up to approximately 43 months
Serious and Other adverse events (AEs) included all participants who received ≥1 dose of study drug. All-Cause Mortality included all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment were excluded as AEs. Data are reported by treatment received.
|
0.00%
0/38 • Up to approximately 43 months
Serious and Other adverse events (AEs) included all participants who received ≥1 dose of study drug. All-Cause Mortality included all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment were excluded as AEs. Data are reported by treatment received.
|
|
Infections and infestations
Pneumonia
|
7.0%
3/43 • Number of events 3 • Up to approximately 43 months
Serious and Other adverse events (AEs) included all participants who received ≥1 dose of study drug. All-Cause Mortality included all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment were excluded as AEs. Data are reported by treatment received.
|
7.3%
3/41 • Number of events 3 • Up to approximately 43 months
Serious and Other adverse events (AEs) included all participants who received ≥1 dose of study drug. All-Cause Mortality included all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment were excluded as AEs. Data are reported by treatment received.
|
13.2%
5/38 • Number of events 5 • Up to approximately 43 months
Serious and Other adverse events (AEs) included all participants who received ≥1 dose of study drug. All-Cause Mortality included all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment were excluded as AEs. Data are reported by treatment received.
|
|
Infections and infestations
Pneumonia aspiration
|
0.00%
0/43 • Up to approximately 43 months
Serious and Other adverse events (AEs) included all participants who received ≥1 dose of study drug. All-Cause Mortality included all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment were excluded as AEs. Data are reported by treatment received.
|
2.4%
1/41 • Number of events 1 • Up to approximately 43 months
Serious and Other adverse events (AEs) included all participants who received ≥1 dose of study drug. All-Cause Mortality included all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment were excluded as AEs. Data are reported by treatment received.
|
0.00%
0/38 • Up to approximately 43 months
Serious and Other adverse events (AEs) included all participants who received ≥1 dose of study drug. All-Cause Mortality included all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment were excluded as AEs. Data are reported by treatment received.
|
|
Infections and infestations
Sepsis
|
4.7%
2/43 • Number of events 2 • Up to approximately 43 months
Serious and Other adverse events (AEs) included all participants who received ≥1 dose of study drug. All-Cause Mortality included all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment were excluded as AEs. Data are reported by treatment received.
|
2.4%
1/41 • Number of events 1 • Up to approximately 43 months
Serious and Other adverse events (AEs) included all participants who received ≥1 dose of study drug. All-Cause Mortality included all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment were excluded as AEs. Data are reported by treatment received.
|
7.9%
3/38 • Number of events 3 • Up to approximately 43 months
Serious and Other adverse events (AEs) included all participants who received ≥1 dose of study drug. All-Cause Mortality included all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment were excluded as AEs. Data are reported by treatment received.
|
|
Infections and infestations
Septic shock
|
2.3%
1/43 • Number of events 1 • Up to approximately 43 months
Serious and Other adverse events (AEs) included all participants who received ≥1 dose of study drug. All-Cause Mortality included all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment were excluded as AEs. Data are reported by treatment received.
|
0.00%
0/41 • Up to approximately 43 months
Serious and Other adverse events (AEs) included all participants who received ≥1 dose of study drug. All-Cause Mortality included all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment were excluded as AEs. Data are reported by treatment received.
|
2.6%
1/38 • Number of events 1 • Up to approximately 43 months
Serious and Other adverse events (AEs) included all participants who received ≥1 dose of study drug. All-Cause Mortality included all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment were excluded as AEs. Data are reported by treatment received.
|
|
Infections and infestations
Wound infection
|
0.00%
0/43 • Up to approximately 43 months
Serious and Other adverse events (AEs) included all participants who received ≥1 dose of study drug. All-Cause Mortality included all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment were excluded as AEs. Data are reported by treatment received.
|
0.00%
0/41 • Up to approximately 43 months
Serious and Other adverse events (AEs) included all participants who received ≥1 dose of study drug. All-Cause Mortality included all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment were excluded as AEs. Data are reported by treatment received.
|
2.6%
1/38 • Number of events 1 • Up to approximately 43 months
Serious and Other adverse events (AEs) included all participants who received ≥1 dose of study drug. All-Cause Mortality included all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment were excluded as AEs. Data are reported by treatment received.
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/43 • Up to approximately 43 months
Serious and Other adverse events (AEs) included all participants who received ≥1 dose of study drug. All-Cause Mortality included all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment were excluded as AEs. Data are reported by treatment received.
|
0.00%
0/41 • Up to approximately 43 months
Serious and Other adverse events (AEs) included all participants who received ≥1 dose of study drug. All-Cause Mortality included all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment were excluded as AEs. Data are reported by treatment received.
|
2.6%
1/38 • Number of events 1 • Up to approximately 43 months
Serious and Other adverse events (AEs) included all participants who received ≥1 dose of study drug. All-Cause Mortality included all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment were excluded as AEs. Data are reported by treatment received.
|
|
Injury, poisoning and procedural complications
Traumatic intracranial haemorrhage
|
0.00%
0/43 • Up to approximately 43 months
Serious and Other adverse events (AEs) included all participants who received ≥1 dose of study drug. All-Cause Mortality included all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment were excluded as AEs. Data are reported by treatment received.
|
0.00%
0/41 • Up to approximately 43 months
Serious and Other adverse events (AEs) included all participants who received ≥1 dose of study drug. All-Cause Mortality included all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment were excluded as AEs. Data are reported by treatment received.
|
2.6%
1/38 • Number of events 1 • Up to approximately 43 months
Serious and Other adverse events (AEs) included all participants who received ≥1 dose of study drug. All-Cause Mortality included all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment were excluded as AEs. Data are reported by treatment received.
|
|
Injury, poisoning and procedural complications
Vascular pseudoaneurysm
|
2.3%
1/43 • Number of events 1 • Up to approximately 43 months
Serious and Other adverse events (AEs) included all participants who received ≥1 dose of study drug. All-Cause Mortality included all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment were excluded as AEs. Data are reported by treatment received.
|
0.00%
0/41 • Up to approximately 43 months
Serious and Other adverse events (AEs) included all participants who received ≥1 dose of study drug. All-Cause Mortality included all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment were excluded as AEs. Data are reported by treatment received.
|
0.00%
0/38 • Up to approximately 43 months
Serious and Other adverse events (AEs) included all participants who received ≥1 dose of study drug. All-Cause Mortality included all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment were excluded as AEs. Data are reported by treatment received.
|
|
Investigations
Blood creatinine increased
|
0.00%
0/43 • Up to approximately 43 months
Serious and Other adverse events (AEs) included all participants who received ≥1 dose of study drug. All-Cause Mortality included all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment were excluded as AEs. Data are reported by treatment received.
|
2.4%
1/41 • Number of events 1 • Up to approximately 43 months
Serious and Other adverse events (AEs) included all participants who received ≥1 dose of study drug. All-Cause Mortality included all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment were excluded as AEs. Data are reported by treatment received.
|
0.00%
0/38 • Up to approximately 43 months
Serious and Other adverse events (AEs) included all participants who received ≥1 dose of study drug. All-Cause Mortality included all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment were excluded as AEs. Data are reported by treatment received.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/43 • Up to approximately 43 months
Serious and Other adverse events (AEs) included all participants who received ≥1 dose of study drug. All-Cause Mortality included all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment were excluded as AEs. Data are reported by treatment received.
|
0.00%
0/41 • Up to approximately 43 months
Serious and Other adverse events (AEs) included all participants who received ≥1 dose of study drug. All-Cause Mortality included all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment were excluded as AEs. Data are reported by treatment received.
|
2.6%
1/38 • Number of events 1 • Up to approximately 43 months
Serious and Other adverse events (AEs) included all participants who received ≥1 dose of study drug. All-Cause Mortality included all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment were excluded as AEs. Data are reported by treatment received.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/43 • Up to approximately 43 months
Serious and Other adverse events (AEs) included all participants who received ≥1 dose of study drug. All-Cause Mortality included all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment were excluded as AEs. Data are reported by treatment received.
|
2.4%
1/41 • Number of events 1 • Up to approximately 43 months
Serious and Other adverse events (AEs) included all participants who received ≥1 dose of study drug. All-Cause Mortality included all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment were excluded as AEs. Data are reported by treatment received.
|
2.6%
1/38 • Number of events 1 • Up to approximately 43 months
Serious and Other adverse events (AEs) included all participants who received ≥1 dose of study drug. All-Cause Mortality included all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment were excluded as AEs. Data are reported by treatment received.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/43 • Up to approximately 43 months
Serious and Other adverse events (AEs) included all participants who received ≥1 dose of study drug. All-Cause Mortality included all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment were excluded as AEs. Data are reported by treatment received.
|
0.00%
0/41 • Up to approximately 43 months
Serious and Other adverse events (AEs) included all participants who received ≥1 dose of study drug. All-Cause Mortality included all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment were excluded as AEs. Data are reported by treatment received.
|
2.6%
1/38 • Number of events 1 • Up to approximately 43 months
Serious and Other adverse events (AEs) included all participants who received ≥1 dose of study drug. All-Cause Mortality included all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment were excluded as AEs. Data are reported by treatment received.
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
2.3%
1/43 • Number of events 1 • Up to approximately 43 months
Serious and Other adverse events (AEs) included all participants who received ≥1 dose of study drug. All-Cause Mortality included all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment were excluded as AEs. Data are reported by treatment received.
|
0.00%
0/41 • Up to approximately 43 months
Serious and Other adverse events (AEs) included all participants who received ≥1 dose of study drug. All-Cause Mortality included all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment were excluded as AEs. Data are reported by treatment received.
|
0.00%
0/38 • Up to approximately 43 months
Serious and Other adverse events (AEs) included all participants who received ≥1 dose of study drug. All-Cause Mortality included all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment were excluded as AEs. Data are reported by treatment received.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adenocarcinoma
|
2.3%
1/43 • Number of events 1 • Up to approximately 43 months
Serious and Other adverse events (AEs) included all participants who received ≥1 dose of study drug. All-Cause Mortality included all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment were excluded as AEs. Data are reported by treatment received.
|
0.00%
0/41 • Up to approximately 43 months
Serious and Other adverse events (AEs) included all participants who received ≥1 dose of study drug. All-Cause Mortality included all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment were excluded as AEs. Data are reported by treatment received.
|
0.00%
0/38 • Up to approximately 43 months
Serious and Other adverse events (AEs) included all participants who received ≥1 dose of study drug. All-Cause Mortality included all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment were excluded as AEs. Data are reported by treatment received.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour associated fever
|
2.3%
1/43 • Number of events 1 • Up to approximately 43 months
Serious and Other adverse events (AEs) included all participants who received ≥1 dose of study drug. All-Cause Mortality included all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment were excluded as AEs. Data are reported by treatment received.
|
0.00%
0/41 • Up to approximately 43 months
Serious and Other adverse events (AEs) included all participants who received ≥1 dose of study drug. All-Cause Mortality included all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment were excluded as AEs. Data are reported by treatment received.
|
0.00%
0/38 • Up to approximately 43 months
Serious and Other adverse events (AEs) included all participants who received ≥1 dose of study drug. All-Cause Mortality included all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment were excluded as AEs. Data are reported by treatment received.
|
|
Nervous system disorders
Cerebral haematoma
|
0.00%
0/43 • Up to approximately 43 months
Serious and Other adverse events (AEs) included all participants who received ≥1 dose of study drug. All-Cause Mortality included all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment were excluded as AEs. Data are reported by treatment received.
|
0.00%
0/41 • Up to approximately 43 months
Serious and Other adverse events (AEs) included all participants who received ≥1 dose of study drug. All-Cause Mortality included all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment were excluded as AEs. Data are reported by treatment received.
|
2.6%
1/38 • Number of events 1 • Up to approximately 43 months
Serious and Other adverse events (AEs) included all participants who received ≥1 dose of study drug. All-Cause Mortality included all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment were excluded as AEs. Data are reported by treatment received.
|
|
Nervous system disorders
Cerebrovascular accident
|
0.00%
0/43 • Up to approximately 43 months
Serious and Other adverse events (AEs) included all participants who received ≥1 dose of study drug. All-Cause Mortality included all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment were excluded as AEs. Data are reported by treatment received.
|
0.00%
0/41 • Up to approximately 43 months
Serious and Other adverse events (AEs) included all participants who received ≥1 dose of study drug. All-Cause Mortality included all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment were excluded as AEs. Data are reported by treatment received.
|
2.6%
1/38 • Number of events 1 • Up to approximately 43 months
Serious and Other adverse events (AEs) included all participants who received ≥1 dose of study drug. All-Cause Mortality included all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment were excluded as AEs. Data are reported by treatment received.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/43 • Up to approximately 43 months
Serious and Other adverse events (AEs) included all participants who received ≥1 dose of study drug. All-Cause Mortality included all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment were excluded as AEs. Data are reported by treatment received.
|
2.4%
1/41 • Number of events 1 • Up to approximately 43 months
Serious and Other adverse events (AEs) included all participants who received ≥1 dose of study drug. All-Cause Mortality included all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment were excluded as AEs. Data are reported by treatment received.
|
0.00%
0/38 • Up to approximately 43 months
Serious and Other adverse events (AEs) included all participants who received ≥1 dose of study drug. All-Cause Mortality included all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment were excluded as AEs. Data are reported by treatment received.
|
|
Nervous system disorders
Encephalitis autoimmune
|
0.00%
0/43 • Up to approximately 43 months
Serious and Other adverse events (AEs) included all participants who received ≥1 dose of study drug. All-Cause Mortality included all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment were excluded as AEs. Data are reported by treatment received.
|
2.4%
1/41 • Number of events 1 • Up to approximately 43 months
Serious and Other adverse events (AEs) included all participants who received ≥1 dose of study drug. All-Cause Mortality included all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment were excluded as AEs. Data are reported by treatment received.
|
0.00%
0/38 • Up to approximately 43 months
Serious and Other adverse events (AEs) included all participants who received ≥1 dose of study drug. All-Cause Mortality included all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment were excluded as AEs. Data are reported by treatment received.
|
|
Nervous system disorders
Guillain-Barre syndrome
|
2.3%
1/43 • Number of events 1 • Up to approximately 43 months
Serious and Other adverse events (AEs) included all participants who received ≥1 dose of study drug. All-Cause Mortality included all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment were excluded as AEs. Data are reported by treatment received.
|
0.00%
0/41 • Up to approximately 43 months
Serious and Other adverse events (AEs) included all participants who received ≥1 dose of study drug. All-Cause Mortality included all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment were excluded as AEs. Data are reported by treatment received.
|
0.00%
0/38 • Up to approximately 43 months
Serious and Other adverse events (AEs) included all participants who received ≥1 dose of study drug. All-Cause Mortality included all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment were excluded as AEs. Data are reported by treatment received.
|
|
Nervous system disorders
Hypoglossal nerve disorder
|
0.00%
0/43 • Up to approximately 43 months
Serious and Other adverse events (AEs) included all participants who received ≥1 dose of study drug. All-Cause Mortality included all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment were excluded as AEs. Data are reported by treatment received.
|
0.00%
0/41 • Up to approximately 43 months
Serious and Other adverse events (AEs) included all participants who received ≥1 dose of study drug. All-Cause Mortality included all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment were excluded as AEs. Data are reported by treatment received.
|
2.6%
1/38 • Number of events 1 • Up to approximately 43 months
Serious and Other adverse events (AEs) included all participants who received ≥1 dose of study drug. All-Cause Mortality included all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment were excluded as AEs. Data are reported by treatment received.
|
|
Nervous system disorders
Spinal cord compression
|
0.00%
0/43 • Up to approximately 43 months
Serious and Other adverse events (AEs) included all participants who received ≥1 dose of study drug. All-Cause Mortality included all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment were excluded as AEs. Data are reported by treatment received.
|
0.00%
0/41 • Up to approximately 43 months
Serious and Other adverse events (AEs) included all participants who received ≥1 dose of study drug. All-Cause Mortality included all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment were excluded as AEs. Data are reported by treatment received.
|
2.6%
1/38 • Number of events 1 • Up to approximately 43 months
Serious and Other adverse events (AEs) included all participants who received ≥1 dose of study drug. All-Cause Mortality included all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment were excluded as AEs. Data are reported by treatment received.
|
|
Renal and urinary disorders
Acute kidney injury
|
2.3%
1/43 • Number of events 1 • Up to approximately 43 months
Serious and Other adverse events (AEs) included all participants who received ≥1 dose of study drug. All-Cause Mortality included all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment were excluded as AEs. Data are reported by treatment received.
|
2.4%
1/41 • Number of events 1 • Up to approximately 43 months
Serious and Other adverse events (AEs) included all participants who received ≥1 dose of study drug. All-Cause Mortality included all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment were excluded as AEs. Data are reported by treatment received.
|
2.6%
1/38 • Number of events 1 • Up to approximately 43 months
Serious and Other adverse events (AEs) included all participants who received ≥1 dose of study drug. All-Cause Mortality included all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment were excluded as AEs. Data are reported by treatment received.
|
|
Renal and urinary disorders
Renal tubular disorder
|
0.00%
0/43 • Up to approximately 43 months
Serious and Other adverse events (AEs) included all participants who received ≥1 dose of study drug. All-Cause Mortality included all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment were excluded as AEs. Data are reported by treatment received.
|
0.00%
0/41 • Up to approximately 43 months
Serious and Other adverse events (AEs) included all participants who received ≥1 dose of study drug. All-Cause Mortality included all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment were excluded as AEs. Data are reported by treatment received.
|
2.6%
1/38 • Number of events 1 • Up to approximately 43 months
Serious and Other adverse events (AEs) included all participants who received ≥1 dose of study drug. All-Cause Mortality included all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment were excluded as AEs. Data are reported by treatment received.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
2.3%
1/43 • Number of events 1 • Up to approximately 43 months
Serious and Other adverse events (AEs) included all participants who received ≥1 dose of study drug. All-Cause Mortality included all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment were excluded as AEs. Data are reported by treatment received.
|
2.4%
1/41 • Number of events 1 • Up to approximately 43 months
Serious and Other adverse events (AEs) included all participants who received ≥1 dose of study drug. All-Cause Mortality included all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment were excluded as AEs. Data are reported by treatment received.
|
0.00%
0/38 • Up to approximately 43 months
Serious and Other adverse events (AEs) included all participants who received ≥1 dose of study drug. All-Cause Mortality included all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment were excluded as AEs. Data are reported by treatment received.
|
|
Respiratory, thoracic and mediastinal disorders
Emphysema
|
0.00%
0/43 • Up to approximately 43 months
Serious and Other adverse events (AEs) included all participants who received ≥1 dose of study drug. All-Cause Mortality included all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment were excluded as AEs. Data are reported by treatment received.
|
2.4%
1/41 • Number of events 1 • Up to approximately 43 months
Serious and Other adverse events (AEs) included all participants who received ≥1 dose of study drug. All-Cause Mortality included all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment were excluded as AEs. Data are reported by treatment received.
|
0.00%
0/38 • Up to approximately 43 months
Serious and Other adverse events (AEs) included all participants who received ≥1 dose of study drug. All-Cause Mortality included all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment were excluded as AEs. Data are reported by treatment received.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
2.3%
1/43 • Number of events 1 • Up to approximately 43 months
Serious and Other adverse events (AEs) included all participants who received ≥1 dose of study drug. All-Cause Mortality included all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment were excluded as AEs. Data are reported by treatment received.
|
0.00%
0/41 • Up to approximately 43 months
Serious and Other adverse events (AEs) included all participants who received ≥1 dose of study drug. All-Cause Mortality included all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment were excluded as AEs. Data are reported by treatment received.
|
2.6%
1/38 • Number of events 1 • Up to approximately 43 months
Serious and Other adverse events (AEs) included all participants who received ≥1 dose of study drug. All-Cause Mortality included all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment were excluded as AEs. Data are reported by treatment received.
|
|
Skin and subcutaneous tissue disorders
Stevens-Johnson syndrome
|
0.00%
0/43 • Up to approximately 43 months
Serious and Other adverse events (AEs) included all participants who received ≥1 dose of study drug. All-Cause Mortality included all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment were excluded as AEs. Data are reported by treatment received.
|
0.00%
0/41 • Up to approximately 43 months
Serious and Other adverse events (AEs) included all participants who received ≥1 dose of study drug. All-Cause Mortality included all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment were excluded as AEs. Data are reported by treatment received.
|
2.6%
1/38 • Number of events 1 • Up to approximately 43 months
Serious and Other adverse events (AEs) included all participants who received ≥1 dose of study drug. All-Cause Mortality included all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment were excluded as AEs. Data are reported by treatment received.
|
|
Vascular disorders
Aneurysm ruptured
|
0.00%
0/43 • Up to approximately 43 months
Serious and Other adverse events (AEs) included all participants who received ≥1 dose of study drug. All-Cause Mortality included all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment were excluded as AEs. Data are reported by treatment received.
|
0.00%
0/41 • Up to approximately 43 months
Serious and Other adverse events (AEs) included all participants who received ≥1 dose of study drug. All-Cause Mortality included all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment were excluded as AEs. Data are reported by treatment received.
|
2.6%
1/38 • Number of events 1 • Up to approximately 43 months
Serious and Other adverse events (AEs) included all participants who received ≥1 dose of study drug. All-Cause Mortality included all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment were excluded as AEs. Data are reported by treatment received.
|
|
Vascular disorders
Femoral artery perforation
|
2.3%
1/43 • Number of events 1 • Up to approximately 43 months
Serious and Other adverse events (AEs) included all participants who received ≥1 dose of study drug. All-Cause Mortality included all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment were excluded as AEs. Data are reported by treatment received.
|
0.00%
0/41 • Up to approximately 43 months
Serious and Other adverse events (AEs) included all participants who received ≥1 dose of study drug. All-Cause Mortality included all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment were excluded as AEs. Data are reported by treatment received.
|
0.00%
0/38 • Up to approximately 43 months
Serious and Other adverse events (AEs) included all participants who received ≥1 dose of study drug. All-Cause Mortality included all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment were excluded as AEs. Data are reported by treatment received.
|
|
Vascular disorders
Peripheral artery occlusion
|
2.3%
1/43 • Number of events 1 • Up to approximately 43 months
Serious and Other adverse events (AEs) included all participants who received ≥1 dose of study drug. All-Cause Mortality included all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment were excluded as AEs. Data are reported by treatment received.
|
0.00%
0/41 • Up to approximately 43 months
Serious and Other adverse events (AEs) included all participants who received ≥1 dose of study drug. All-Cause Mortality included all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment were excluded as AEs. Data are reported by treatment received.
|
0.00%
0/38 • Up to approximately 43 months
Serious and Other adverse events (AEs) included all participants who received ≥1 dose of study drug. All-Cause Mortality included all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment were excluded as AEs. Data are reported by treatment received.
|
Other adverse events
| Measure |
MK-4830 + Pembrolizumab + Etoposide/Platinum
n=43 participants at risk
Participants receive pembrolizumab 200 mg IV infusion on Day 1 of each cycle (cycle length = 3 weeks) every 3 weeks (Q3W) up to 35 administrations (up to approximately 2 years) or until disease progression (PD) or discontinuation, MK-4830 800 mg IV infusion on Day 1 of each cycle Q3W, up to 35 administrations (up to approximately 2 years) or until PD or discontinuation; etoposide 100 mg/m\^2 on Days 1, 2, 3 of each cycle for up to 4 cycles (up to approximately 12 weeks) and cisplatin 75 mg/m\^2 or carboplatin AUC 5 mg/ml/min IV, Day 1 of each cycle Q3W up to 4 cycles (up to approximately 12 weeks) or until PD or discontinuation.
|
MK-5890 + Pembrolizumab +Etoposide/Platinum
n=41 participants at risk
Participants receive pembrolizumab 200 mg IV infusion on Day 1 of each cycle Q3W up to 35 administrations (up to approximately 2 years) or until PD or discontinuation, boserolimab 30 mg IV infusion on Day 1 of each cycle (cycle length = 6 weeks) every 6 weeks (Q6W), up to 18 administrations (up to approximately 2 years) or until PD or discontinuation; etoposide 100 mg/m\^2 on Days 1, 2, 3 of each cycle for up to 4 cycles (up to approximately 12 weeks) and cisplatin 75 mg/m\^2 or carboplatin AUC 5 mg/ml/min IV, Day 1 of each cycle Q3W up to 4 cycles (up to approximately 12 weeks) or until PD or discontinuation.
|
Lenvatinib +Pembrolizumab + Etoposide/Platinum
n=38 participants at risk
Participants receive pembrolizumab 200 mg IV infusion on Day 1 of each 3 week cycle (Q3W) up to 35 administrations (up to approximately 2 years) or until PD or discontinuation, lenvatinib 8 mg once daily (QD) orally up to Cycles 1-4 cycles and up to 20 mg QD orally for Cycles 5-31 or until PD or discontinuation; etoposide 100 mg/m\^2 on Days 1, 2, 3 of each cycle for up to 4 cycles (up to approximately 12 weeks) and cisplatin 75 mg/m\^2 or carboplatin AUC 5 mg/ml/min IV, Day 1 of each cycle Q3W up to 4 cycles (up to approximately 12 weeks) or until PD or discontinuation.
|
|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
60.5%
26/43 • Number of events 34 • Up to approximately 43 months
Serious and Other adverse events (AEs) included all participants who received ≥1 dose of study drug. All-Cause Mortality included all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment were excluded as AEs. Data are reported by treatment received.
|
56.1%
23/41 • Number of events 29 • Up to approximately 43 months
Serious and Other adverse events (AEs) included all participants who received ≥1 dose of study drug. All-Cause Mortality included all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment were excluded as AEs. Data are reported by treatment received.
|
65.8%
25/38 • Number of events 45 • Up to approximately 43 months
Serious and Other adverse events (AEs) included all participants who received ≥1 dose of study drug. All-Cause Mortality included all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment were excluded as AEs. Data are reported by treatment received.
|
|
Blood and lymphatic system disorders
Leukopenia
|
32.6%
14/43 • Number of events 18 • Up to approximately 43 months
Serious and Other adverse events (AEs) included all participants who received ≥1 dose of study drug. All-Cause Mortality included all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment were excluded as AEs. Data are reported by treatment received.
|
34.1%
14/41 • Number of events 24 • Up to approximately 43 months
Serious and Other adverse events (AEs) included all participants who received ≥1 dose of study drug. All-Cause Mortality included all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment were excluded as AEs. Data are reported by treatment received.
|
18.4%
7/38 • Number of events 15 • Up to approximately 43 months
Serious and Other adverse events (AEs) included all participants who received ≥1 dose of study drug. All-Cause Mortality included all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment were excluded as AEs. Data are reported by treatment received.
|
|
Blood and lymphatic system disorders
Neutropenia
|
69.8%
30/43 • Number of events 51 • Up to approximately 43 months
Serious and Other adverse events (AEs) included all participants who received ≥1 dose of study drug. All-Cause Mortality included all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment were excluded as AEs. Data are reported by treatment received.
|
70.7%
29/41 • Number of events 47 • Up to approximately 43 months
Serious and Other adverse events (AEs) included all participants who received ≥1 dose of study drug. All-Cause Mortality included all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment were excluded as AEs. Data are reported by treatment received.
|
78.9%
30/38 • Number of events 70 • Up to approximately 43 months
Serious and Other adverse events (AEs) included all participants who received ≥1 dose of study drug. All-Cause Mortality included all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment were excluded as AEs. Data are reported by treatment received.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
23.3%
10/43 • Number of events 17 • Up to approximately 43 months
Serious and Other adverse events (AEs) included all participants who received ≥1 dose of study drug. All-Cause Mortality included all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment were excluded as AEs. Data are reported by treatment received.
|
36.6%
15/41 • Number of events 24 • Up to approximately 43 months
Serious and Other adverse events (AEs) included all participants who received ≥1 dose of study drug. All-Cause Mortality included all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment were excluded as AEs. Data are reported by treatment received.
|
55.3%
21/38 • Number of events 50 • Up to approximately 43 months
Serious and Other adverse events (AEs) included all participants who received ≥1 dose of study drug. All-Cause Mortality included all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment were excluded as AEs. Data are reported by treatment received.
|
|
Endocrine disorders
Adrenal insufficiency
|
0.00%
0/43 • Up to approximately 43 months
Serious and Other adverse events (AEs) included all participants who received ≥1 dose of study drug. All-Cause Mortality included all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment were excluded as AEs. Data are reported by treatment received.
|
0.00%
0/41 • Up to approximately 43 months
Serious and Other adverse events (AEs) included all participants who received ≥1 dose of study drug. All-Cause Mortality included all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment were excluded as AEs. Data are reported by treatment received.
|
5.3%
2/38 • Number of events 2 • Up to approximately 43 months
Serious and Other adverse events (AEs) included all participants who received ≥1 dose of study drug. All-Cause Mortality included all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment were excluded as AEs. Data are reported by treatment received.
|
|
Endocrine disorders
Hyperthyroidism
|
11.6%
5/43 • Number of events 7 • Up to approximately 43 months
Serious and Other adverse events (AEs) included all participants who received ≥1 dose of study drug. All-Cause Mortality included all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment were excluded as AEs. Data are reported by treatment received.
|
14.6%
6/41 • Number of events 6 • Up to approximately 43 months
Serious and Other adverse events (AEs) included all participants who received ≥1 dose of study drug. All-Cause Mortality included all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment were excluded as AEs. Data are reported by treatment received.
|
10.5%
4/38 • Number of events 4 • Up to approximately 43 months
Serious and Other adverse events (AEs) included all participants who received ≥1 dose of study drug. All-Cause Mortality included all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment were excluded as AEs. Data are reported by treatment received.
|
|
Endocrine disorders
Hypothyroidism
|
18.6%
8/43 • Number of events 11 • Up to approximately 43 months
Serious and Other adverse events (AEs) included all participants who received ≥1 dose of study drug. All-Cause Mortality included all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment were excluded as AEs. Data are reported by treatment received.
|
19.5%
8/41 • Number of events 8 • Up to approximately 43 months
Serious and Other adverse events (AEs) included all participants who received ≥1 dose of study drug. All-Cause Mortality included all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment were excluded as AEs. Data are reported by treatment received.
|
39.5%
15/38 • Number of events 18 • Up to approximately 43 months
Serious and Other adverse events (AEs) included all participants who received ≥1 dose of study drug. All-Cause Mortality included all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment were excluded as AEs. Data are reported by treatment received.
|
|
Gastrointestinal disorders
Constipation
|
16.3%
7/43 • Number of events 9 • Up to approximately 43 months
Serious and Other adverse events (AEs) included all participants who received ≥1 dose of study drug. All-Cause Mortality included all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment were excluded as AEs. Data are reported by treatment received.
|
17.1%
7/41 • Number of events 7 • Up to approximately 43 months
Serious and Other adverse events (AEs) included all participants who received ≥1 dose of study drug. All-Cause Mortality included all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment were excluded as AEs. Data are reported by treatment received.
|
13.2%
5/38 • Number of events 5 • Up to approximately 43 months
Serious and Other adverse events (AEs) included all participants who received ≥1 dose of study drug. All-Cause Mortality included all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment were excluded as AEs. Data are reported by treatment received.
|
|
Gastrointestinal disorders
Diarrhoea
|
18.6%
8/43 • Number of events 11 • Up to approximately 43 months
Serious and Other adverse events (AEs) included all participants who received ≥1 dose of study drug. All-Cause Mortality included all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment were excluded as AEs. Data are reported by treatment received.
|
7.3%
3/41 • Number of events 3 • Up to approximately 43 months
Serious and Other adverse events (AEs) included all participants who received ≥1 dose of study drug. All-Cause Mortality included all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment were excluded as AEs. Data are reported by treatment received.
|
44.7%
17/38 • Number of events 23 • Up to approximately 43 months
Serious and Other adverse events (AEs) included all participants who received ≥1 dose of study drug. All-Cause Mortality included all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment were excluded as AEs. Data are reported by treatment received.
|
|
Gastrointestinal disorders
Dry mouth
|
4.7%
2/43 • Number of events 2 • Up to approximately 43 months
Serious and Other adverse events (AEs) included all participants who received ≥1 dose of study drug. All-Cause Mortality included all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment were excluded as AEs. Data are reported by treatment received.
|
0.00%
0/41 • Up to approximately 43 months
Serious and Other adverse events (AEs) included all participants who received ≥1 dose of study drug. All-Cause Mortality included all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment were excluded as AEs. Data are reported by treatment received.
|
5.3%
2/38 • Number of events 2 • Up to approximately 43 months
Serious and Other adverse events (AEs) included all participants who received ≥1 dose of study drug. All-Cause Mortality included all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment were excluded as AEs. Data are reported by treatment received.
|
|
Gastrointestinal disorders
Dyspepsia
|
4.7%
2/43 • Number of events 2 • Up to approximately 43 months
Serious and Other adverse events (AEs) included all participants who received ≥1 dose of study drug. All-Cause Mortality included all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment were excluded as AEs. Data are reported by treatment received.
|
4.9%
2/41 • Number of events 2 • Up to approximately 43 months
Serious and Other adverse events (AEs) included all participants who received ≥1 dose of study drug. All-Cause Mortality included all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment were excluded as AEs. Data are reported by treatment received.
|
7.9%
3/38 • Number of events 3 • Up to approximately 43 months
Serious and Other adverse events (AEs) included all participants who received ≥1 dose of study drug. All-Cause Mortality included all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment were excluded as AEs. Data are reported by treatment received.
|
|
Gastrointestinal disorders
Gastritis
|
4.7%
2/43 • Number of events 3 • Up to approximately 43 months
Serious and Other adverse events (AEs) included all participants who received ≥1 dose of study drug. All-Cause Mortality included all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment were excluded as AEs. Data are reported by treatment received.
|
0.00%
0/41 • Up to approximately 43 months
Serious and Other adverse events (AEs) included all participants who received ≥1 dose of study drug. All-Cause Mortality included all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment were excluded as AEs. Data are reported by treatment received.
|
7.9%
3/38 • Number of events 3 • Up to approximately 43 months
Serious and Other adverse events (AEs) included all participants who received ≥1 dose of study drug. All-Cause Mortality included all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment were excluded as AEs. Data are reported by treatment received.
|
|
Gastrointestinal disorders
Nausea
|
32.6%
14/43 • Number of events 21 • Up to approximately 43 months
Serious and Other adverse events (AEs) included all participants who received ≥1 dose of study drug. All-Cause Mortality included all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment were excluded as AEs. Data are reported by treatment received.
|
14.6%
6/41 • Number of events 10 • Up to approximately 43 months
Serious and Other adverse events (AEs) included all participants who received ≥1 dose of study drug. All-Cause Mortality included all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment were excluded as AEs. Data are reported by treatment received.
|
31.6%
12/38 • Number of events 15 • Up to approximately 43 months
Serious and Other adverse events (AEs) included all participants who received ≥1 dose of study drug. All-Cause Mortality included all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment were excluded as AEs. Data are reported by treatment received.
|
|
Gastrointestinal disorders
Stomatitis
|
9.3%
4/43 • Number of events 4 • Up to approximately 43 months
Serious and Other adverse events (AEs) included all participants who received ≥1 dose of study drug. All-Cause Mortality included all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment were excluded as AEs. Data are reported by treatment received.
|
4.9%
2/41 • Number of events 2 • Up to approximately 43 months
Serious and Other adverse events (AEs) included all participants who received ≥1 dose of study drug. All-Cause Mortality included all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment were excluded as AEs. Data are reported by treatment received.
|
26.3%
10/38 • Number of events 12 • Up to approximately 43 months
Serious and Other adverse events (AEs) included all participants who received ≥1 dose of study drug. All-Cause Mortality included all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment were excluded as AEs. Data are reported by treatment received.
|
|
Gastrointestinal disorders
Vomiting
|
9.3%
4/43 • Number of events 4 • Up to approximately 43 months
Serious and Other adverse events (AEs) included all participants who received ≥1 dose of study drug. All-Cause Mortality included all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment were excluded as AEs. Data are reported by treatment received.
|
12.2%
5/41 • Number of events 6 • Up to approximately 43 months
Serious and Other adverse events (AEs) included all participants who received ≥1 dose of study drug. All-Cause Mortality included all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment were excluded as AEs. Data are reported by treatment received.
|
7.9%
3/38 • Number of events 3 • Up to approximately 43 months
Serious and Other adverse events (AEs) included all participants who received ≥1 dose of study drug. All-Cause Mortality included all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment were excluded as AEs. Data are reported by treatment received.
|
|
General disorders
Asthenia
|
7.0%
3/43 • Number of events 3 • Up to approximately 43 months
Serious and Other adverse events (AEs) included all participants who received ≥1 dose of study drug. All-Cause Mortality included all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment were excluded as AEs. Data are reported by treatment received.
|
2.4%
1/41 • Number of events 1 • Up to approximately 43 months
Serious and Other adverse events (AEs) included all participants who received ≥1 dose of study drug. All-Cause Mortality included all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment were excluded as AEs. Data are reported by treatment received.
|
5.3%
2/38 • Number of events 2 • Up to approximately 43 months
Serious and Other adverse events (AEs) included all participants who received ≥1 dose of study drug. All-Cause Mortality included all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment were excluded as AEs. Data are reported by treatment received.
|
|
General disorders
Fatigue
|
30.2%
13/43 • Number of events 14 • Up to approximately 43 months
Serious and Other adverse events (AEs) included all participants who received ≥1 dose of study drug. All-Cause Mortality included all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment were excluded as AEs. Data are reported by treatment received.
|
17.1%
7/41 • Number of events 9 • Up to approximately 43 months
Serious and Other adverse events (AEs) included all participants who received ≥1 dose of study drug. All-Cause Mortality included all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment were excluded as AEs. Data are reported by treatment received.
|
28.9%
11/38 • Number of events 12 • Up to approximately 43 months
Serious and Other adverse events (AEs) included all participants who received ≥1 dose of study drug. All-Cause Mortality included all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment were excluded as AEs. Data are reported by treatment received.
|
|
General disorders
Non-cardiac chest pain
|
4.7%
2/43 • Number of events 2 • Up to approximately 43 months
Serious and Other adverse events (AEs) included all participants who received ≥1 dose of study drug. All-Cause Mortality included all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment were excluded as AEs. Data are reported by treatment received.
|
4.9%
2/41 • Number of events 2 • Up to approximately 43 months
Serious and Other adverse events (AEs) included all participants who received ≥1 dose of study drug. All-Cause Mortality included all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment were excluded as AEs. Data are reported by treatment received.
|
5.3%
2/38 • Number of events 2 • Up to approximately 43 months
Serious and Other adverse events (AEs) included all participants who received ≥1 dose of study drug. All-Cause Mortality included all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment were excluded as AEs. Data are reported by treatment received.
|
|
General disorders
Oedema peripheral
|
4.7%
2/43 • Number of events 2 • Up to approximately 43 months
Serious and Other adverse events (AEs) included all participants who received ≥1 dose of study drug. All-Cause Mortality included all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment were excluded as AEs. Data are reported by treatment received.
|
0.00%
0/41 • Up to approximately 43 months
Serious and Other adverse events (AEs) included all participants who received ≥1 dose of study drug. All-Cause Mortality included all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment were excluded as AEs. Data are reported by treatment received.
|
15.8%
6/38 • Number of events 6 • Up to approximately 43 months
Serious and Other adverse events (AEs) included all participants who received ≥1 dose of study drug. All-Cause Mortality included all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment were excluded as AEs. Data are reported by treatment received.
|
|
General disorders
Pain
|
0.00%
0/43 • Up to approximately 43 months
Serious and Other adverse events (AEs) included all participants who received ≥1 dose of study drug. All-Cause Mortality included all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment were excluded as AEs. Data are reported by treatment received.
|
2.4%
1/41 • Number of events 1 • Up to approximately 43 months
Serious and Other adverse events (AEs) included all participants who received ≥1 dose of study drug. All-Cause Mortality included all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment were excluded as AEs. Data are reported by treatment received.
|
5.3%
2/38 • Number of events 2 • Up to approximately 43 months
Serious and Other adverse events (AEs) included all participants who received ≥1 dose of study drug. All-Cause Mortality included all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment were excluded as AEs. Data are reported by treatment received.
|
|
General disorders
Pyrexia
|
7.0%
3/43 • Number of events 6 • Up to approximately 43 months
Serious and Other adverse events (AEs) included all participants who received ≥1 dose of study drug. All-Cause Mortality included all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment were excluded as AEs. Data are reported by treatment received.
|
4.9%
2/41 • Number of events 2 • Up to approximately 43 months
Serious and Other adverse events (AEs) included all participants who received ≥1 dose of study drug. All-Cause Mortality included all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment were excluded as AEs. Data are reported by treatment received.
|
5.3%
2/38 • Number of events 6 • Up to approximately 43 months
Serious and Other adverse events (AEs) included all participants who received ≥1 dose of study drug. All-Cause Mortality included all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment were excluded as AEs. Data are reported by treatment received.
|
|
Infections and infestations
COVID-19
|
14.0%
6/43 • Number of events 6 • Up to approximately 43 months
Serious and Other adverse events (AEs) included all participants who received ≥1 dose of study drug. All-Cause Mortality included all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment were excluded as AEs. Data are reported by treatment received.
|
2.4%
1/41 • Number of events 1 • Up to approximately 43 months
Serious and Other adverse events (AEs) included all participants who received ≥1 dose of study drug. All-Cause Mortality included all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment were excluded as AEs. Data are reported by treatment received.
|
15.8%
6/38 • Number of events 6 • Up to approximately 43 months
Serious and Other adverse events (AEs) included all participants who received ≥1 dose of study drug. All-Cause Mortality included all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment were excluded as AEs. Data are reported by treatment received.
|
|
Infections and infestations
Gingivitis
|
4.7%
2/43 • Number of events 2 • Up to approximately 43 months
Serious and Other adverse events (AEs) included all participants who received ≥1 dose of study drug. All-Cause Mortality included all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment were excluded as AEs. Data are reported by treatment received.
|
0.00%
0/41 • Up to approximately 43 months
Serious and Other adverse events (AEs) included all participants who received ≥1 dose of study drug. All-Cause Mortality included all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment were excluded as AEs. Data are reported by treatment received.
|
7.9%
3/38 • Number of events 3 • Up to approximately 43 months
Serious and Other adverse events (AEs) included all participants who received ≥1 dose of study drug. All-Cause Mortality included all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment were excluded as AEs. Data are reported by treatment received.
|
|
Infections and infestations
Rash pustular
|
4.7%
2/43 • Number of events 2 • Up to approximately 43 months
Serious and Other adverse events (AEs) included all participants who received ≥1 dose of study drug. All-Cause Mortality included all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment were excluded as AEs. Data are reported by treatment received.
|
0.00%
0/41 • Up to approximately 43 months
Serious and Other adverse events (AEs) included all participants who received ≥1 dose of study drug. All-Cause Mortality included all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment were excluded as AEs. Data are reported by treatment received.
|
5.3%
2/38 • Number of events 2 • Up to approximately 43 months
Serious and Other adverse events (AEs) included all participants who received ≥1 dose of study drug. All-Cause Mortality included all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment were excluded as AEs. Data are reported by treatment received.
|
|
Infections and infestations
Skin infection
|
0.00%
0/43 • Up to approximately 43 months
Serious and Other adverse events (AEs) included all participants who received ≥1 dose of study drug. All-Cause Mortality included all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment were excluded as AEs. Data are reported by treatment received.
|
0.00%
0/41 • Up to approximately 43 months
Serious and Other adverse events (AEs) included all participants who received ≥1 dose of study drug. All-Cause Mortality included all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment were excluded as AEs. Data are reported by treatment received.
|
5.3%
2/38 • Number of events 2 • Up to approximately 43 months
Serious and Other adverse events (AEs) included all participants who received ≥1 dose of study drug. All-Cause Mortality included all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment were excluded as AEs. Data are reported by treatment received.
|
|
Infections and infestations
Urinary tract infection
|
7.0%
3/43 • Number of events 4 • Up to approximately 43 months
Serious and Other adverse events (AEs) included all participants who received ≥1 dose of study drug. All-Cause Mortality included all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment were excluded as AEs. Data are reported by treatment received.
|
4.9%
2/41 • Number of events 2 • Up to approximately 43 months
Serious and Other adverse events (AEs) included all participants who received ≥1 dose of study drug. All-Cause Mortality included all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment were excluded as AEs. Data are reported by treatment received.
|
0.00%
0/38 • Up to approximately 43 months
Serious and Other adverse events (AEs) included all participants who received ≥1 dose of study drug. All-Cause Mortality included all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment were excluded as AEs. Data are reported by treatment received.
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
2.3%
1/43 • Number of events 1 • Up to approximately 43 months
Serious and Other adverse events (AEs) included all participants who received ≥1 dose of study drug. All-Cause Mortality included all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment were excluded as AEs. Data are reported by treatment received.
|
12.2%
5/41 • Number of events 8 • Up to approximately 43 months
Serious and Other adverse events (AEs) included all participants who received ≥1 dose of study drug. All-Cause Mortality included all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment were excluded as AEs. Data are reported by treatment received.
|
5.3%
2/38 • Number of events 2 • Up to approximately 43 months
Serious and Other adverse events (AEs) included all participants who received ≥1 dose of study drug. All-Cause Mortality included all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment were excluded as AEs. Data are reported by treatment received.
|
|
Investigations
Alanine aminotransferase increased
|
7.0%
3/43 • Number of events 4 • Up to approximately 43 months
Serious and Other adverse events (AEs) included all participants who received ≥1 dose of study drug. All-Cause Mortality included all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment were excluded as AEs. Data are reported by treatment received.
|
14.6%
6/41 • Number of events 10 • Up to approximately 43 months
Serious and Other adverse events (AEs) included all participants who received ≥1 dose of study drug. All-Cause Mortality included all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment were excluded as AEs. Data are reported by treatment received.
|
21.1%
8/38 • Number of events 11 • Up to approximately 43 months
Serious and Other adverse events (AEs) included all participants who received ≥1 dose of study drug. All-Cause Mortality included all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment were excluded as AEs. Data are reported by treatment received.
|
|
Investigations
Aspartate aminotransferase increased
|
4.7%
2/43 • Number of events 2 • Up to approximately 43 months
Serious and Other adverse events (AEs) included all participants who received ≥1 dose of study drug. All-Cause Mortality included all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment were excluded as AEs. Data are reported by treatment received.
|
17.1%
7/41 • Number of events 8 • Up to approximately 43 months
Serious and Other adverse events (AEs) included all participants who received ≥1 dose of study drug. All-Cause Mortality included all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment were excluded as AEs. Data are reported by treatment received.
|
21.1%
8/38 • Number of events 14 • Up to approximately 43 months
Serious and Other adverse events (AEs) included all participants who received ≥1 dose of study drug. All-Cause Mortality included all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment were excluded as AEs. Data are reported by treatment received.
|
|
Investigations
Blood alkaline phosphatase increased
|
4.7%
2/43 • Number of events 2 • Up to approximately 43 months
Serious and Other adverse events (AEs) included all participants who received ≥1 dose of study drug. All-Cause Mortality included all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment were excluded as AEs. Data are reported by treatment received.
|
2.4%
1/41 • Number of events 1 • Up to approximately 43 months
Serious and Other adverse events (AEs) included all participants who received ≥1 dose of study drug. All-Cause Mortality included all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment were excluded as AEs. Data are reported by treatment received.
|
7.9%
3/38 • Number of events 5 • Up to approximately 43 months
Serious and Other adverse events (AEs) included all participants who received ≥1 dose of study drug. All-Cause Mortality included all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment were excluded as AEs. Data are reported by treatment received.
|
|
Investigations
Blood bilirubin increased
|
2.3%
1/43 • Number of events 1 • Up to approximately 43 months
Serious and Other adverse events (AEs) included all participants who received ≥1 dose of study drug. All-Cause Mortality included all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment were excluded as AEs. Data are reported by treatment received.
|
12.2%
5/41 • Number of events 8 • Up to approximately 43 months
Serious and Other adverse events (AEs) included all participants who received ≥1 dose of study drug. All-Cause Mortality included all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment were excluded as AEs. Data are reported by treatment received.
|
5.3%
2/38 • Number of events 3 • Up to approximately 43 months
Serious and Other adverse events (AEs) included all participants who received ≥1 dose of study drug. All-Cause Mortality included all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment were excluded as AEs. Data are reported by treatment received.
|
|
Investigations
Blood creatinine increased
|
9.3%
4/43 • Number of events 5 • Up to approximately 43 months
Serious and Other adverse events (AEs) included all participants who received ≥1 dose of study drug. All-Cause Mortality included all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment were excluded as AEs. Data are reported by treatment received.
|
12.2%
5/41 • Number of events 6 • Up to approximately 43 months
Serious and Other adverse events (AEs) included all participants who received ≥1 dose of study drug. All-Cause Mortality included all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment were excluded as AEs. Data are reported by treatment received.
|
13.2%
5/38 • Number of events 11 • Up to approximately 43 months
Serious and Other adverse events (AEs) included all participants who received ≥1 dose of study drug. All-Cause Mortality included all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment were excluded as AEs. Data are reported by treatment received.
|
|
Investigations
Blood thyroid stimulating hormone increased
|
0.00%
0/43 • Up to approximately 43 months
Serious and Other adverse events (AEs) included all participants who received ≥1 dose of study drug. All-Cause Mortality included all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment were excluded as AEs. Data are reported by treatment received.
|
0.00%
0/41 • Up to approximately 43 months
Serious and Other adverse events (AEs) included all participants who received ≥1 dose of study drug. All-Cause Mortality included all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment were excluded as AEs. Data are reported by treatment received.
|
5.3%
2/38 • Number of events 3 • Up to approximately 43 months
Serious and Other adverse events (AEs) included all participants who received ≥1 dose of study drug. All-Cause Mortality included all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment were excluded as AEs. Data are reported by treatment received.
|
|
Investigations
Lymphocyte count decreased
|
4.7%
2/43 • Number of events 2 • Up to approximately 43 months
Serious and Other adverse events (AEs) included all participants who received ≥1 dose of study drug. All-Cause Mortality included all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment were excluded as AEs. Data are reported by treatment received.
|
9.8%
4/41 • Number of events 12 • Up to approximately 43 months
Serious and Other adverse events (AEs) included all participants who received ≥1 dose of study drug. All-Cause Mortality included all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment were excluded as AEs. Data are reported by treatment received.
|
0.00%
0/38 • Up to approximately 43 months
Serious and Other adverse events (AEs) included all participants who received ≥1 dose of study drug. All-Cause Mortality included all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment were excluded as AEs. Data are reported by treatment received.
|
|
Investigations
SARS-CoV-2 test positive
|
9.3%
4/43 • Number of events 4 • Up to approximately 43 months
Serious and Other adverse events (AEs) included all participants who received ≥1 dose of study drug. All-Cause Mortality included all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment were excluded as AEs. Data are reported by treatment received.
|
0.00%
0/41 • Up to approximately 43 months
Serious and Other adverse events (AEs) included all participants who received ≥1 dose of study drug. All-Cause Mortality included all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment were excluded as AEs. Data are reported by treatment received.
|
0.00%
0/38 • Up to approximately 43 months
Serious and Other adverse events (AEs) included all participants who received ≥1 dose of study drug. All-Cause Mortality included all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment were excluded as AEs. Data are reported by treatment received.
|
|
Investigations
Weight decreased
|
9.3%
4/43 • Number of events 4 • Up to approximately 43 months
Serious and Other adverse events (AEs) included all participants who received ≥1 dose of study drug. All-Cause Mortality included all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment were excluded as AEs. Data are reported by treatment received.
|
7.3%
3/41 • Number of events 3 • Up to approximately 43 months
Serious and Other adverse events (AEs) included all participants who received ≥1 dose of study drug. All-Cause Mortality included all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment were excluded as AEs. Data are reported by treatment received.
|
13.2%
5/38 • Number of events 5 • Up to approximately 43 months
Serious and Other adverse events (AEs) included all participants who received ≥1 dose of study drug. All-Cause Mortality included all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment were excluded as AEs. Data are reported by treatment received.
|
|
Investigations
Weight increased
|
14.0%
6/43 • Number of events 7 • Up to approximately 43 months
Serious and Other adverse events (AEs) included all participants who received ≥1 dose of study drug. All-Cause Mortality included all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment were excluded as AEs. Data are reported by treatment received.
|
0.00%
0/41 • Up to approximately 43 months
Serious and Other adverse events (AEs) included all participants who received ≥1 dose of study drug. All-Cause Mortality included all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment were excluded as AEs. Data are reported by treatment received.
|
0.00%
0/38 • Up to approximately 43 months
Serious and Other adverse events (AEs) included all participants who received ≥1 dose of study drug. All-Cause Mortality included all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment were excluded as AEs. Data are reported by treatment received.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
16.3%
7/43 • Number of events 8 • Up to approximately 43 months
Serious and Other adverse events (AEs) included all participants who received ≥1 dose of study drug. All-Cause Mortality included all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment were excluded as AEs. Data are reported by treatment received.
|
9.8%
4/41 • Number of events 4 • Up to approximately 43 months
Serious and Other adverse events (AEs) included all participants who received ≥1 dose of study drug. All-Cause Mortality included all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment were excluded as AEs. Data are reported by treatment received.
|
28.9%
11/38 • Number of events 11 • Up to approximately 43 months
Serious and Other adverse events (AEs) included all participants who received ≥1 dose of study drug. All-Cause Mortality included all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment were excluded as AEs. Data are reported by treatment received.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
9.3%
4/43 • Number of events 4 • Up to approximately 43 months
Serious and Other adverse events (AEs) included all participants who received ≥1 dose of study drug. All-Cause Mortality included all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment were excluded as AEs. Data are reported by treatment received.
|
2.4%
1/41 • Number of events 2 • Up to approximately 43 months
Serious and Other adverse events (AEs) included all participants who received ≥1 dose of study drug. All-Cause Mortality included all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment were excluded as AEs. Data are reported by treatment received.
|
2.6%
1/38 • Number of events 1 • Up to approximately 43 months
Serious and Other adverse events (AEs) included all participants who received ≥1 dose of study drug. All-Cause Mortality included all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment were excluded as AEs. Data are reported by treatment received.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
2.3%
1/43 • Number of events 2 • Up to approximately 43 months
Serious and Other adverse events (AEs) included all participants who received ≥1 dose of study drug. All-Cause Mortality included all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment were excluded as AEs. Data are reported by treatment received.
|
2.4%
1/41 • Number of events 2 • Up to approximately 43 months
Serious and Other adverse events (AEs) included all participants who received ≥1 dose of study drug. All-Cause Mortality included all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment were excluded as AEs. Data are reported by treatment received.
|
10.5%
4/38 • Number of events 6 • Up to approximately 43 months
Serious and Other adverse events (AEs) included all participants who received ≥1 dose of study drug. All-Cause Mortality included all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment were excluded as AEs. Data are reported by treatment received.
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
4.7%
2/43 • Number of events 2 • Up to approximately 43 months
Serious and Other adverse events (AEs) included all participants who received ≥1 dose of study drug. All-Cause Mortality included all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment were excluded as AEs. Data are reported by treatment received.
|
0.00%
0/41 • Up to approximately 43 months
Serious and Other adverse events (AEs) included all participants who received ≥1 dose of study drug. All-Cause Mortality included all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment were excluded as AEs. Data are reported by treatment received.
|
5.3%
2/38 • Number of events 2 • Up to approximately 43 months
Serious and Other adverse events (AEs) included all participants who received ≥1 dose of study drug. All-Cause Mortality included all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment were excluded as AEs. Data are reported by treatment received.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
11.6%
5/43 • Number of events 9 • Up to approximately 43 months
Serious and Other adverse events (AEs) included all participants who received ≥1 dose of study drug. All-Cause Mortality included all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment were excluded as AEs. Data are reported by treatment received.
|
7.3%
3/41 • Number of events 3 • Up to approximately 43 months
Serious and Other adverse events (AEs) included all participants who received ≥1 dose of study drug. All-Cause Mortality included all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment were excluded as AEs. Data are reported by treatment received.
|
10.5%
4/38 • Number of events 6 • Up to approximately 43 months
Serious and Other adverse events (AEs) included all participants who received ≥1 dose of study drug. All-Cause Mortality included all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment were excluded as AEs. Data are reported by treatment received.
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
9.3%
4/43 • Number of events 9 • Up to approximately 43 months
Serious and Other adverse events (AEs) included all participants who received ≥1 dose of study drug. All-Cause Mortality included all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment were excluded as AEs. Data are reported by treatment received.
|
7.3%
3/41 • Number of events 4 • Up to approximately 43 months
Serious and Other adverse events (AEs) included all participants who received ≥1 dose of study drug. All-Cause Mortality included all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment were excluded as AEs. Data are reported by treatment received.
|
7.9%
3/38 • Number of events 5 • Up to approximately 43 months
Serious and Other adverse events (AEs) included all participants who received ≥1 dose of study drug. All-Cause Mortality included all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment were excluded as AEs. Data are reported by treatment received.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
18.6%
8/43 • Number of events 8 • Up to approximately 43 months
Serious and Other adverse events (AEs) included all participants who received ≥1 dose of study drug. All-Cause Mortality included all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment were excluded as AEs. Data are reported by treatment received.
|
7.3%
3/41 • Number of events 3 • Up to approximately 43 months
Serious and Other adverse events (AEs) included all participants who received ≥1 dose of study drug. All-Cause Mortality included all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment were excluded as AEs. Data are reported by treatment received.
|
13.2%
5/38 • Number of events 7 • Up to approximately 43 months
Serious and Other adverse events (AEs) included all participants who received ≥1 dose of study drug. All-Cause Mortality included all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment were excluded as AEs. Data are reported by treatment received.
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
4.7%
2/43 • Number of events 2 • Up to approximately 43 months
Serious and Other adverse events (AEs) included all participants who received ≥1 dose of study drug. All-Cause Mortality included all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment were excluded as AEs. Data are reported by treatment received.
|
4.9%
2/41 • Number of events 2 • Up to approximately 43 months
Serious and Other adverse events (AEs) included all participants who received ≥1 dose of study drug. All-Cause Mortality included all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment were excluded as AEs. Data are reported by treatment received.
|
5.3%
2/38 • Number of events 2 • Up to approximately 43 months
Serious and Other adverse events (AEs) included all participants who received ≥1 dose of study drug. All-Cause Mortality included all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment were excluded as AEs. Data are reported by treatment received.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
16.3%
7/43 • Number of events 11 • Up to approximately 43 months
Serious and Other adverse events (AEs) included all participants who received ≥1 dose of study drug. All-Cause Mortality included all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment were excluded as AEs. Data are reported by treatment received.
|
9.8%
4/41 • Number of events 5 • Up to approximately 43 months
Serious and Other adverse events (AEs) included all participants who received ≥1 dose of study drug. All-Cause Mortality included all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment were excluded as AEs. Data are reported by treatment received.
|
13.2%
5/38 • Number of events 6 • Up to approximately 43 months
Serious and Other adverse events (AEs) included all participants who received ≥1 dose of study drug. All-Cause Mortality included all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment were excluded as AEs. Data are reported by treatment received.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
9.3%
4/43 • Number of events 6 • Up to approximately 43 months
Serious and Other adverse events (AEs) included all participants who received ≥1 dose of study drug. All-Cause Mortality included all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment were excluded as AEs. Data are reported by treatment received.
|
4.9%
2/41 • Number of events 2 • Up to approximately 43 months
Serious and Other adverse events (AEs) included all participants who received ≥1 dose of study drug. All-Cause Mortality included all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment were excluded as AEs. Data are reported by treatment received.
|
7.9%
3/38 • Number of events 3 • Up to approximately 43 months
Serious and Other adverse events (AEs) included all participants who received ≥1 dose of study drug. All-Cause Mortality included all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment were excluded as AEs. Data are reported by treatment received.
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
4.7%
2/43 • Number of events 3 • Up to approximately 43 months
Serious and Other adverse events (AEs) included all participants who received ≥1 dose of study drug. All-Cause Mortality included all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment were excluded as AEs. Data are reported by treatment received.
|
17.1%
7/41 • Number of events 7 • Up to approximately 43 months
Serious and Other adverse events (AEs) included all participants who received ≥1 dose of study drug. All-Cause Mortality included all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment were excluded as AEs. Data are reported by treatment received.
|
0.00%
0/38 • Up to approximately 43 months
Serious and Other adverse events (AEs) included all participants who received ≥1 dose of study drug. All-Cause Mortality included all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment were excluded as AEs. Data are reported by treatment received.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour associated fever
|
0.00%
0/43 • Up to approximately 43 months
Serious and Other adverse events (AEs) included all participants who received ≥1 dose of study drug. All-Cause Mortality included all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment were excluded as AEs. Data are reported by treatment received.
|
0.00%
0/41 • Up to approximately 43 months
Serious and Other adverse events (AEs) included all participants who received ≥1 dose of study drug. All-Cause Mortality included all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment were excluded as AEs. Data are reported by treatment received.
|
5.3%
2/38 • Number of events 2 • Up to approximately 43 months
Serious and Other adverse events (AEs) included all participants who received ≥1 dose of study drug. All-Cause Mortality included all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment were excluded as AEs. Data are reported by treatment received.
|
|
Nervous system disorders
Dizziness
|
11.6%
5/43 • Number of events 5 • Up to approximately 43 months
Serious and Other adverse events (AEs) included all participants who received ≥1 dose of study drug. All-Cause Mortality included all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment were excluded as AEs. Data are reported by treatment received.
|
2.4%
1/41 • Number of events 1 • Up to approximately 43 months
Serious and Other adverse events (AEs) included all participants who received ≥1 dose of study drug. All-Cause Mortality included all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment were excluded as AEs. Data are reported by treatment received.
|
10.5%
4/38 • Number of events 4 • Up to approximately 43 months
Serious and Other adverse events (AEs) included all participants who received ≥1 dose of study drug. All-Cause Mortality included all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment were excluded as AEs. Data are reported by treatment received.
|
|
Nervous system disorders
Headache
|
14.0%
6/43 • Number of events 6 • Up to approximately 43 months
Serious and Other adverse events (AEs) included all participants who received ≥1 dose of study drug. All-Cause Mortality included all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment were excluded as AEs. Data are reported by treatment received.
|
12.2%
5/41 • Number of events 5 • Up to approximately 43 months
Serious and Other adverse events (AEs) included all participants who received ≥1 dose of study drug. All-Cause Mortality included all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment were excluded as AEs. Data are reported by treatment received.
|
13.2%
5/38 • Number of events 5 • Up to approximately 43 months
Serious and Other adverse events (AEs) included all participants who received ≥1 dose of study drug. All-Cause Mortality included all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment were excluded as AEs. Data are reported by treatment received.
|
|
Nervous system disorders
Paraesthesia
|
7.0%
3/43 • Number of events 4 • Up to approximately 43 months
Serious and Other adverse events (AEs) included all participants who received ≥1 dose of study drug. All-Cause Mortality included all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment were excluded as AEs. Data are reported by treatment received.
|
0.00%
0/41 • Up to approximately 43 months
Serious and Other adverse events (AEs) included all participants who received ≥1 dose of study drug. All-Cause Mortality included all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment were excluded as AEs. Data are reported by treatment received.
|
7.9%
3/38 • Number of events 3 • Up to approximately 43 months
Serious and Other adverse events (AEs) included all participants who received ≥1 dose of study drug. All-Cause Mortality included all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment were excluded as AEs. Data are reported by treatment received.
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
0.00%
0/43 • Up to approximately 43 months
Serious and Other adverse events (AEs) included all participants who received ≥1 dose of study drug. All-Cause Mortality included all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment were excluded as AEs. Data are reported by treatment received.
|
2.4%
1/41 • Number of events 1 • Up to approximately 43 months
Serious and Other adverse events (AEs) included all participants who received ≥1 dose of study drug. All-Cause Mortality included all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment were excluded as AEs. Data are reported by treatment received.
|
5.3%
2/38 • Number of events 2 • Up to approximately 43 months
Serious and Other adverse events (AEs) included all participants who received ≥1 dose of study drug. All-Cause Mortality included all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment were excluded as AEs. Data are reported by treatment received.
|
|
Psychiatric disorders
Anxiety
|
2.3%
1/43 • Number of events 1 • Up to approximately 43 months
Serious and Other adverse events (AEs) included all participants who received ≥1 dose of study drug. All-Cause Mortality included all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment were excluded as AEs. Data are reported by treatment received.
|
0.00%
0/41 • Up to approximately 43 months
Serious and Other adverse events (AEs) included all participants who received ≥1 dose of study drug. All-Cause Mortality included all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment were excluded as AEs. Data are reported by treatment received.
|
5.3%
2/38 • Number of events 2 • Up to approximately 43 months
Serious and Other adverse events (AEs) included all participants who received ≥1 dose of study drug. All-Cause Mortality included all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment were excluded as AEs. Data are reported by treatment received.
|
|
Psychiatric disorders
Delirium
|
0.00%
0/43 • Up to approximately 43 months
Serious and Other adverse events (AEs) included all participants who received ≥1 dose of study drug. All-Cause Mortality included all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment were excluded as AEs. Data are reported by treatment received.
|
0.00%
0/41 • Up to approximately 43 months
Serious and Other adverse events (AEs) included all participants who received ≥1 dose of study drug. All-Cause Mortality included all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment were excluded as AEs. Data are reported by treatment received.
|
5.3%
2/38 • Number of events 2 • Up to approximately 43 months
Serious and Other adverse events (AEs) included all participants who received ≥1 dose of study drug. All-Cause Mortality included all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment were excluded as AEs. Data are reported by treatment received.
|
|
Psychiatric disorders
Insomnia
|
11.6%
5/43 • Number of events 5 • Up to approximately 43 months
Serious and Other adverse events (AEs) included all participants who received ≥1 dose of study drug. All-Cause Mortality included all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment were excluded as AEs. Data are reported by treatment received.
|
4.9%
2/41 • Number of events 2 • Up to approximately 43 months
Serious and Other adverse events (AEs) included all participants who received ≥1 dose of study drug. All-Cause Mortality included all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment were excluded as AEs. Data are reported by treatment received.
|
10.5%
4/38 • Number of events 4 • Up to approximately 43 months
Serious and Other adverse events (AEs) included all participants who received ≥1 dose of study drug. All-Cause Mortality included all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment were excluded as AEs. Data are reported by treatment received.
|
|
Renal and urinary disorders
Dysuria
|
7.0%
3/43 • Number of events 3 • Up to approximately 43 months
Serious and Other adverse events (AEs) included all participants who received ≥1 dose of study drug. All-Cause Mortality included all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment were excluded as AEs. Data are reported by treatment received.
|
2.4%
1/41 • Number of events 1 • Up to approximately 43 months
Serious and Other adverse events (AEs) included all participants who received ≥1 dose of study drug. All-Cause Mortality included all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment were excluded as AEs. Data are reported by treatment received.
|
2.6%
1/38 • Number of events 1 • Up to approximately 43 months
Serious and Other adverse events (AEs) included all participants who received ≥1 dose of study drug. All-Cause Mortality included all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment were excluded as AEs. Data are reported by treatment received.
|
|
Renal and urinary disorders
Proteinuria
|
0.00%
0/43 • Up to approximately 43 months
Serious and Other adverse events (AEs) included all participants who received ≥1 dose of study drug. All-Cause Mortality included all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment were excluded as AEs. Data are reported by treatment received.
|
2.4%
1/41 • Number of events 1 • Up to approximately 43 months
Serious and Other adverse events (AEs) included all participants who received ≥1 dose of study drug. All-Cause Mortality included all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment were excluded as AEs. Data are reported by treatment received.
|
47.4%
18/38 • Number of events 35 • Up to approximately 43 months
Serious and Other adverse events (AEs) included all participants who received ≥1 dose of study drug. All-Cause Mortality included all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment were excluded as AEs. Data are reported by treatment received.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
11.6%
5/43 • Number of events 5 • Up to approximately 43 months
Serious and Other adverse events (AEs) included all participants who received ≥1 dose of study drug. All-Cause Mortality included all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment were excluded as AEs. Data are reported by treatment received.
|
2.4%
1/41 • Number of events 1 • Up to approximately 43 months
Serious and Other adverse events (AEs) included all participants who received ≥1 dose of study drug. All-Cause Mortality included all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment were excluded as AEs. Data are reported by treatment received.
|
5.3%
2/38 • Number of events 2 • Up to approximately 43 months
Serious and Other adverse events (AEs) included all participants who received ≥1 dose of study drug. All-Cause Mortality included all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment were excluded as AEs. Data are reported by treatment received.
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
2.3%
1/43 • Number of events 1 • Up to approximately 43 months
Serious and Other adverse events (AEs) included all participants who received ≥1 dose of study drug. All-Cause Mortality included all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment were excluded as AEs. Data are reported by treatment received.
|
2.4%
1/41 • Number of events 1 • Up to approximately 43 months
Serious and Other adverse events (AEs) included all participants who received ≥1 dose of study drug. All-Cause Mortality included all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment were excluded as AEs. Data are reported by treatment received.
|
5.3%
2/38 • Number of events 2 • Up to approximately 43 months
Serious and Other adverse events (AEs) included all participants who received ≥1 dose of study drug. All-Cause Mortality included all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment were excluded as AEs. Data are reported by treatment received.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
11.6%
5/43 • Number of events 5 • Up to approximately 43 months
Serious and Other adverse events (AEs) included all participants who received ≥1 dose of study drug. All-Cause Mortality included all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment were excluded as AEs. Data are reported by treatment received.
|
4.9%
2/41 • Number of events 2 • Up to approximately 43 months
Serious and Other adverse events (AEs) included all participants who received ≥1 dose of study drug. All-Cause Mortality included all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment were excluded as AEs. Data are reported by treatment received.
|
5.3%
2/38 • Number of events 2 • Up to approximately 43 months
Serious and Other adverse events (AEs) included all participants who received ≥1 dose of study drug. All-Cause Mortality included all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment were excluded as AEs. Data are reported by treatment received.
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
11.6%
5/43 • Number of events 6 • Up to approximately 43 months
Serious and Other adverse events (AEs) included all participants who received ≥1 dose of study drug. All-Cause Mortality included all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment were excluded as AEs. Data are reported by treatment received.
|
2.4%
1/41 • Number of events 1 • Up to approximately 43 months
Serious and Other adverse events (AEs) included all participants who received ≥1 dose of study drug. All-Cause Mortality included all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment were excluded as AEs. Data are reported by treatment received.
|
5.3%
2/38 • Number of events 2 • Up to approximately 43 months
Serious and Other adverse events (AEs) included all participants who received ≥1 dose of study drug. All-Cause Mortality included all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment were excluded as AEs. Data are reported by treatment received.
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
2.3%
1/43 • Number of events 1 • Up to approximately 43 months
Serious and Other adverse events (AEs) included all participants who received ≥1 dose of study drug. All-Cause Mortality included all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment were excluded as AEs. Data are reported by treatment received.
|
7.3%
3/41 • Number of events 3 • Up to approximately 43 months
Serious and Other adverse events (AEs) included all participants who received ≥1 dose of study drug. All-Cause Mortality included all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment were excluded as AEs. Data are reported by treatment received.
|
2.6%
1/38 • Number of events 1 • Up to approximately 43 months
Serious and Other adverse events (AEs) included all participants who received ≥1 dose of study drug. All-Cause Mortality included all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment were excluded as AEs. Data are reported by treatment received.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/43 • Up to approximately 43 months
Serious and Other adverse events (AEs) included all participants who received ≥1 dose of study drug. All-Cause Mortality included all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment were excluded as AEs. Data are reported by treatment received.
|
0.00%
0/41 • Up to approximately 43 months
Serious and Other adverse events (AEs) included all participants who received ≥1 dose of study drug. All-Cause Mortality included all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment were excluded as AEs. Data are reported by treatment received.
|
13.2%
5/38 • Number of events 5 • Up to approximately 43 months
Serious and Other adverse events (AEs) included all participants who received ≥1 dose of study drug. All-Cause Mortality included all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment were excluded as AEs. Data are reported by treatment received.
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
7.0%
3/43 • Number of events 3 • Up to approximately 43 months
Serious and Other adverse events (AEs) included all participants who received ≥1 dose of study drug. All-Cause Mortality included all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment were excluded as AEs. Data are reported by treatment received.
|
2.4%
1/41 • Number of events 1 • Up to approximately 43 months
Serious and Other adverse events (AEs) included all participants who received ≥1 dose of study drug. All-Cause Mortality included all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment were excluded as AEs. Data are reported by treatment received.
|
2.6%
1/38 • Number of events 1 • Up to approximately 43 months
Serious and Other adverse events (AEs) included all participants who received ≥1 dose of study drug. All-Cause Mortality included all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment were excluded as AEs. Data are reported by treatment received.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
9.3%
4/43 • Number of events 4 • Up to approximately 43 months
Serious and Other adverse events (AEs) included all participants who received ≥1 dose of study drug. All-Cause Mortality included all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment were excluded as AEs. Data are reported by treatment received.
|
2.4%
1/41 • Number of events 1 • Up to approximately 43 months
Serious and Other adverse events (AEs) included all participants who received ≥1 dose of study drug. All-Cause Mortality included all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment were excluded as AEs. Data are reported by treatment received.
|
0.00%
0/38 • Up to approximately 43 months
Serious and Other adverse events (AEs) included all participants who received ≥1 dose of study drug. All-Cause Mortality included all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment were excluded as AEs. Data are reported by treatment received.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
18.6%
8/43 • Number of events 8 • Up to approximately 43 months
Serious and Other adverse events (AEs) included all participants who received ≥1 dose of study drug. All-Cause Mortality included all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment were excluded as AEs. Data are reported by treatment received.
|
22.0%
9/41 • Number of events 9 • Up to approximately 43 months
Serious and Other adverse events (AEs) included all participants who received ≥1 dose of study drug. All-Cause Mortality included all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment were excluded as AEs. Data are reported by treatment received.
|
15.8%
6/38 • Number of events 6 • Up to approximately 43 months
Serious and Other adverse events (AEs) included all participants who received ≥1 dose of study drug. All-Cause Mortality included all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment were excluded as AEs. Data are reported by treatment received.
|
|
Skin and subcutaneous tissue disorders
Dermatitis acneiform
|
2.3%
1/43 • Number of events 1 • Up to approximately 43 months
Serious and Other adverse events (AEs) included all participants who received ≥1 dose of study drug. All-Cause Mortality included all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment were excluded as AEs. Data are reported by treatment received.
|
2.4%
1/41 • Number of events 1 • Up to approximately 43 months
Serious and Other adverse events (AEs) included all participants who received ≥1 dose of study drug. All-Cause Mortality included all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment were excluded as AEs. Data are reported by treatment received.
|
5.3%
2/38 • Number of events 3 • Up to approximately 43 months
Serious and Other adverse events (AEs) included all participants who received ≥1 dose of study drug. All-Cause Mortality included all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment were excluded as AEs. Data are reported by treatment received.
|
|
Skin and subcutaneous tissue disorders
Palmar-plantar erythrodysaesthesia syndrome
|
0.00%
0/43 • Up to approximately 43 months
Serious and Other adverse events (AEs) included all participants who received ≥1 dose of study drug. All-Cause Mortality included all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment were excluded as AEs. Data are reported by treatment received.
|
0.00%
0/41 • Up to approximately 43 months
Serious and Other adverse events (AEs) included all participants who received ≥1 dose of study drug. All-Cause Mortality included all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment were excluded as AEs. Data are reported by treatment received.
|
13.2%
5/38 • Number of events 7 • Up to approximately 43 months
Serious and Other adverse events (AEs) included all participants who received ≥1 dose of study drug. All-Cause Mortality included all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment were excluded as AEs. Data are reported by treatment received.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
18.6%
8/43 • Number of events 8 • Up to approximately 43 months
Serious and Other adverse events (AEs) included all participants who received ≥1 dose of study drug. All-Cause Mortality included all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment were excluded as AEs. Data are reported by treatment received.
|
14.6%
6/41 • Number of events 6 • Up to approximately 43 months
Serious and Other adverse events (AEs) included all participants who received ≥1 dose of study drug. All-Cause Mortality included all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment were excluded as AEs. Data are reported by treatment received.
|
15.8%
6/38 • Number of events 6 • Up to approximately 43 months
Serious and Other adverse events (AEs) included all participants who received ≥1 dose of study drug. All-Cause Mortality included all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment were excluded as AEs. Data are reported by treatment received.
|
|
Skin and subcutaneous tissue disorders
Rash
|
2.3%
1/43 • Number of events 1 • Up to approximately 43 months
Serious and Other adverse events (AEs) included all participants who received ≥1 dose of study drug. All-Cause Mortality included all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment were excluded as AEs. Data are reported by treatment received.
|
0.00%
0/41 • Up to approximately 43 months
Serious and Other adverse events (AEs) included all participants who received ≥1 dose of study drug. All-Cause Mortality included all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment were excluded as AEs. Data are reported by treatment received.
|
5.3%
2/38 • Number of events 2 • Up to approximately 43 months
Serious and Other adverse events (AEs) included all participants who received ≥1 dose of study drug. All-Cause Mortality included all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment were excluded as AEs. Data are reported by treatment received.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
14.0%
6/43 • Number of events 6 • Up to approximately 43 months
Serious and Other adverse events (AEs) included all participants who received ≥1 dose of study drug. All-Cause Mortality included all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment were excluded as AEs. Data are reported by treatment received.
|
14.6%
6/41 • Number of events 6 • Up to approximately 43 months
Serious and Other adverse events (AEs) included all participants who received ≥1 dose of study drug. All-Cause Mortality included all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment were excluded as AEs. Data are reported by treatment received.
|
7.9%
3/38 • Number of events 3 • Up to approximately 43 months
Serious and Other adverse events (AEs) included all participants who received ≥1 dose of study drug. All-Cause Mortality included all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment were excluded as AEs. Data are reported by treatment received.
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.00%
0/43 • Up to approximately 43 months
Serious and Other adverse events (AEs) included all participants who received ≥1 dose of study drug. All-Cause Mortality included all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment were excluded as AEs. Data are reported by treatment received.
|
2.4%
1/41 • Number of events 1 • Up to approximately 43 months
Serious and Other adverse events (AEs) included all participants who received ≥1 dose of study drug. All-Cause Mortality included all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment were excluded as AEs. Data are reported by treatment received.
|
5.3%
2/38 • Number of events 2 • Up to approximately 43 months
Serious and Other adverse events (AEs) included all participants who received ≥1 dose of study drug. All-Cause Mortality included all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment were excluded as AEs. Data are reported by treatment received.
|
|
Vascular disorders
Hypertension
|
16.3%
7/43 • Number of events 8 • Up to approximately 43 months
Serious and Other adverse events (AEs) included all participants who received ≥1 dose of study drug. All-Cause Mortality included all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment were excluded as AEs. Data are reported by treatment received.
|
4.9%
2/41 • Number of events 2 • Up to approximately 43 months
Serious and Other adverse events (AEs) included all participants who received ≥1 dose of study drug. All-Cause Mortality included all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment were excluded as AEs. Data are reported by treatment received.
|
31.6%
12/38 • Number of events 22 • Up to approximately 43 months
Serious and Other adverse events (AEs) included all participants who received ≥1 dose of study drug. All-Cause Mortality included all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment were excluded as AEs. Data are reported by treatment received.
|
|
Vascular disorders
Hypotension
|
2.3%
1/43 • Number of events 1 • Up to approximately 43 months
Serious and Other adverse events (AEs) included all participants who received ≥1 dose of study drug. All-Cause Mortality included all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment were excluded as AEs. Data are reported by treatment received.
|
2.4%
1/41 • Number of events 1 • Up to approximately 43 months
Serious and Other adverse events (AEs) included all participants who received ≥1 dose of study drug. All-Cause Mortality included all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment were excluded as AEs. Data are reported by treatment received.
|
7.9%
3/38 • Number of events 3 • Up to approximately 43 months
Serious and Other adverse events (AEs) included all participants who received ≥1 dose of study drug. All-Cause Mortality included all randomized participants. Per protocol, disease progression of cancer under study was not considered an AE unless considered related to study treatment. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" \& "Disease progression" not related to study treatment were excluded as AEs. Data are reported by treatment received.
|
Additional Information
Senior Vice President, Global Clinical Development
Merck Sharp & Dohme LLC
Phone: 1-800-672-6372
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee If publication activity is not directed by the Sponsor, the investigator agrees to submit all manuscripts or abstracts to the Sponsor before submission. This allows the Sponsor to protect proprietary information and to provide comments. Authorship will be determined by mutual agreement and in line with International Committee of Medical Journal Editors (ICMJE) authorship requirements.
- Publication restrictions are in place
Restriction type: OTHER