Trial Outcomes & Findings for Study of Nanoliposomal Irinotecan (Nal-IRI)-Containing Regimens Versus Nab-paclitaxel Plus Gemcitabine in Patients With Previously Untreated, Metastatic Pancreatic Adenocarcinoma (NCT NCT02551991)
NCT ID: NCT02551991
Last Updated: 2022-10-10
Results Overview
Adverse events (AEs) were considered to be DLTs if they occurred during the safety evaluation period (i.e, 28 days of Cycle 1; or 14 days after the second dose of study treatment if there was a treatment delay) and were deemed related to the study treatment regimen. Any AE that was related to disease progression was not considered a DLT.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
56 participants
Primary outcome timeframe
From the start of the first study treatment (Cycle 1 Day 1) up to 14 days after the second dose of study treatment, maximum of 42 days
Results posted on
2022-10-10
Participant Flow
This Phase 2 non-comparative, open-label study was conducted in previously untreated metastatic pancreatic cancer participants at 15 investigational sites in Australia, Spain and USA between 19 October 2015 and 15 February 2021.
This study was divided into 2 parts: Part 1 (dose exploration \[Part 1A\] followed by dose expansion \[Part 1B\] of the irinotecan liposome injection + 5 fluorouracil \[5-FU\]/leucovorin \[LV\] + oxaliplatin regimen) and Part 2 (comparison of irinotecan liposome injection-containing regimen versus \[vs\] nab-paclitaxel plus gemcitabine). Overall, 56 participants were enrolled in this study.
Participant milestones
| Measure |
Dose Exploration: Cohort 1
Participants received irinotecan liposome injection 70 milligram per square meter (mg/m\^2) followed by oxaliplatin 60 mg/m\^2 followed by LV 400 mg/m\^2 and then 5-FU 2400 mg/m\^2 intravenous (IV) infusion on Days 1 and 15 of each 28-day cycle until disease progression, death, unacceptable study treatment-related toxicity or withdrawal of consent.
|
Dose Exploration: Cohort -1
Participants received irinotecan liposome injection 50 mg/m\^2 followed by oxaliplatin 60 mg/m\^2 followed by LV 400 mg/m\^2 and then 5-FU 2400 mg/m\^2 IV infusion on Days 1 and 15 of each 28-day cycle until disease progression, death, unacceptable study treatment-related toxicity or withdrawal of consent.
|
Dose Exploration: Cohort -2B
Participants received irinotecan liposome injection 50 mg/m\^2 followed by oxaliplatin 85 mg/m\^2 followed by LV 400 mg/m\^2 and then 5-FU 2400 mg/m\^2 IV infusion on Days 1 and 15 of each 28-day cycle until disease progression, death, unacceptable study treatment-related toxicity or withdrawal of consent.
|
Dose Exploration: Cohort -3
Participants received irinotecan liposome injection 55 mg/m\^2 followed by oxaliplatin 70 mg/m\^2 followed by LV 400 mg/m\^2 and then 5-FU 2400 mg/m\^2 IV infusion on Days 1 and 15 of each 28-day cycle until disease progression, death, unacceptable study treatment-related toxicity or withdrawal of consent.
|
Dose Expansion: Cohort -1
Participants received irinotecan liposome injection 50 mg/m\^2 followed by oxaliplatin 60 mg/m\^2 followed by LV 400 mg/m\^2 and then 5-FU 2400 mg/m\^2 IV infusion on Days 1 and 15 of each 28-day cycle until disease progression, death, unacceptable study treatment-related toxicity or withdrawal of consent.
|
|---|---|---|---|---|---|
|
Overall Study
STARTED
|
7
|
7
|
10
|
7
|
25
|
|
Overall Study
COMPLETED
|
0
|
0
|
0
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
7
|
7
|
10
|
7
|
25
|
Reasons for withdrawal
| Measure |
Dose Exploration: Cohort 1
Participants received irinotecan liposome injection 70 milligram per square meter (mg/m\^2) followed by oxaliplatin 60 mg/m\^2 followed by LV 400 mg/m\^2 and then 5-FU 2400 mg/m\^2 intravenous (IV) infusion on Days 1 and 15 of each 28-day cycle until disease progression, death, unacceptable study treatment-related toxicity or withdrawal of consent.
|
Dose Exploration: Cohort -1
Participants received irinotecan liposome injection 50 mg/m\^2 followed by oxaliplatin 60 mg/m\^2 followed by LV 400 mg/m\^2 and then 5-FU 2400 mg/m\^2 IV infusion on Days 1 and 15 of each 28-day cycle until disease progression, death, unacceptable study treatment-related toxicity or withdrawal of consent.
|
Dose Exploration: Cohort -2B
Participants received irinotecan liposome injection 50 mg/m\^2 followed by oxaliplatin 85 mg/m\^2 followed by LV 400 mg/m\^2 and then 5-FU 2400 mg/m\^2 IV infusion on Days 1 and 15 of each 28-day cycle until disease progression, death, unacceptable study treatment-related toxicity or withdrawal of consent.
|
Dose Exploration: Cohort -3
Participants received irinotecan liposome injection 55 mg/m\^2 followed by oxaliplatin 70 mg/m\^2 followed by LV 400 mg/m\^2 and then 5-FU 2400 mg/m\^2 IV infusion on Days 1 and 15 of each 28-day cycle until disease progression, death, unacceptable study treatment-related toxicity or withdrawal of consent.
|
Dose Expansion: Cohort -1
Participants received irinotecan liposome injection 50 mg/m\^2 followed by oxaliplatin 60 mg/m\^2 followed by LV 400 mg/m\^2 and then 5-FU 2400 mg/m\^2 IV infusion on Days 1 and 15 of each 28-day cycle until disease progression, death, unacceptable study treatment-related toxicity or withdrawal of consent.
|
|---|---|---|---|---|---|
|
Overall Study
Death
|
5
|
7
|
8
|
7
|
17
|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
0
|
0
|
2
|
|
Overall Study
Lost to Follow-up
|
0
|
0
|
1
|
0
|
0
|
|
Overall Study
Sponsor Decision
|
1
|
0
|
1
|
0
|
5
|
|
Overall Study
Other
|
0
|
0
|
0
|
0
|
1
|
Baseline Characteristics
Study of Nanoliposomal Irinotecan (Nal-IRI)-Containing Regimens Versus Nab-paclitaxel Plus Gemcitabine in Patients With Previously Untreated, Metastatic Pancreatic Adenocarcinoma
Baseline characteristics by cohort
| Measure |
Dose Exploration: Cohort 1
n=7 Participants
Participants received irinotecan liposome injection 70 mg/m\^2 followed by oxaliplatin 60 mg/m\^2 followed by LV 400 mg/m\^2 and then 5-FU 2400 mg/m\^2 IV infusion on Days 1 and 15 of each 28-day cycle until disease progression, death, unacceptable study treatment-related toxicity or withdrawal of consent.
|
Dose Exploration: Cohort -1
n=7 Participants
Participants received irinotecan liposome injection 50 mg/m\^2 followed by oxaliplatin 60 mg/m\^2 followed by LV 400 mg/m\^2 and then 5-FU 2400 mg/m\^2 IV infusion on Days 1 and 15 of each 28-day cycle until disease progression, death, unacceptable study treatment-related toxicity or withdrawal of consent.
|
Dose Exploration: Cohort -2B
n=10 Participants
Participants received irinotecan liposome injection 50 mg/m\^2 followed by oxaliplatin 85 mg/m\^2 followed by LV 400 mg/m\^2 and then 5-FU 2400 mg/m\^2 IV infusion on Days 1 and 15 of each 28-day cycle until disease progression, death, unacceptable study treatment-related toxicity or withdrawal of consent.
|
Dose Exploration: Cohort -3
n=7 Participants
Participants received irinotecan liposome injection 55 mg/m\^2 followed by oxaliplatin 70 mg/m\^2 followed by LV 400 mg/m\^2 and then 5-FU 2400 mg/m\^2 IV infusion on Days 1 and 15 of each 28-day cycle until disease progression, death, unacceptable study treatment-related toxicity or withdrawal of consent.
|
Dose Expansion: Cohort -1
n=25 Participants
Participants received irinotecan liposome injection 50 mg/m\^2 followed by oxaliplatin 60 mg/m\^2 followed by LV 400 mg/m\^2 and then 5-FU 2400 mg/m\^2 IV infusion on Days 1 and 15 of each 28-day cycle until disease progression, death, unacceptable study treatment-related toxicity or withdrawal of consent.
|
Total
n=56 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|
|
Age, Customized
< 65 years
|
4 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
4 Participants
n=7 Participants
|
19 Participants
n=31 Participants
|
34 Participants
n=30 Participants
|
|
Age, Customized
>= 65 years
|
3 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
7 Participants
n=206 Participants
|
3 Participants
n=7 Participants
|
6 Participants
n=31 Participants
|
22 Participants
n=30 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
2 Participants
n=7 Participants
|
14 Participants
n=31 Participants
|
28 Participants
n=30 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
8 Participants
n=206 Participants
|
5 Participants
n=7 Participants
|
11 Participants
n=31 Participants
|
28 Participants
n=30 Participants
|
|
Race/Ethnicity, Customized
White
|
6 Participants
n=99 Participants
|
7 Participants
n=107 Participants
|
9 Participants
n=206 Participants
|
7 Participants
n=7 Participants
|
21 Participants
n=31 Participants
|
50 Participants
n=30 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=31 Participants
|
2 Participants
n=30 Participants
|
|
Race/Ethnicity, Customized
Asian
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=31 Participants
|
3 Participants
n=30 Participants
|
|
Race/Ethnicity, Customized
Not Reportable
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=31 Participants
|
1 Participants
n=30 Participants
|
|
Race/Ethnicity, Customized
Hispanic or Latino
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
4 Participants
n=31 Participants
|
4 Participants
n=30 Participants
|
|
Race/Ethnicity, Customized
Not Hispanic or Latino
|
7 Participants
n=99 Participants
|
7 Participants
n=107 Participants
|
10 Participants
n=206 Participants
|
7 Participants
n=7 Participants
|
21 Participants
n=31 Participants
|
52 Participants
n=30 Participants
|
PRIMARY outcome
Timeframe: From the start of the first study treatment (Cycle 1 Day 1) up to 14 days after the second dose of study treatment, maximum of 42 daysPopulation: Safety population included participants who received at least 1 dose of any study treatment.
Adverse events (AEs) were considered to be DLTs if they occurred during the safety evaluation period (i.e, 28 days of Cycle 1; or 14 days after the second dose of study treatment if there was a treatment delay) and were deemed related to the study treatment regimen. Any AE that was related to disease progression was not considered a DLT.
Outcome measures
| Measure |
Dose Exploration: Cohort 1
n=7 Participants
Participants received irinotecan liposome injection 70 mg/m\^2 followed by oxaliplatin 60 mg/m\^2 followed by LV 400 mg/m\^2 and then 5-FU 2400 mg/m\^2 IV infusion on Days 1 and 15 of each 28-day cycle until disease progression, death, unacceptable study treatment-related toxicity or withdrawal of consent.
|
Dose Exploration: Cohort -1
n=7 Participants
Participants received irinotecan liposome injection 50 mg/m\^2 followed by oxaliplatin 60 mg/m\^2 followed by LV 400 mg/m\^2 and then 5-FU 2400 mg/m\^2 IV infusion on Days 1 and 15 of each 28-day cycle until disease progression, death, unacceptable study treatment-related toxicity or withdrawal of consent.
|
Dose Exploration: Cohort -2B
n=10 Participants
Participants received irinotecan liposome injection 50 mg/m\^2 followed by oxaliplatin 85 mg/m\^2 followed by LV 400 mg/m\^2 and then 5-FU 2400 mg/m\^2 IV infusion on Days 1 and 15 of each 28-day cycle until disease progression, death, unacceptable study treatment-related toxicity or withdrawal of consent.
|
Dose Exploration: Cohort -3
n=7 Participants
Participants received irinotecan liposome injection 55 mg/m\^2 followed by oxaliplatin 70 mg/m\^2 followed by LV 400 mg/m\^2 and then 5-FU 2400 mg/m\^2 IV infusion on Days 1 and 15 of each 28-day cycle until disease progression, death, unacceptable study treatment-related toxicity or withdrawal of consent.
|
Dose Expansion: Cohort -1
Participants received irinotecan liposome injection 50 mg/m\^2 followed by oxaliplatin 60 mg/m\^2 followed by LV 400 mg/m\^2 and then 5-FU 2400 mg/m\^2 IV infusion on Days 1 and 15 of each 28-day cycle until disease progression, death, unacceptable study treatment-related toxicity or withdrawal of consent.
|
Cohort -1: Pooled
Participants received irinotecan liposome injection 50 mg/m\^2 followed by oxaliplatin 60 mg/m\^2 followed by LV 400 mg/m\^2 and then 5-FU 2400 mg/m\^2 IV infusion on Days 1 and 15 of each 28-day cycle until disease progression, death, unacceptable study treatment-related toxicity or withdrawal of consent.
|
|---|---|---|---|---|---|---|
|
Part 1A: Number of Participants With Dose-Limiting Toxicities (DLT)
|
2 Participants
|
1 Participants
|
2 Participants
|
0 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: RECIST assessments performed at baseline (within 28 days before start of study treatment), every 8 weeks after first dose, end of treatment (EoT) visit, then every 2 months thereafter (maximum of 278 weeks).Population: Safety population included participants who received at least 1 dose of any study treatment.
The PFS was defined as the time from date of first study treatment to the first documented radiographical progression of disease (PD), per investigator using Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1, or death from any cause, whichever comes first. The PFS was calculated using Kaplan-Meier technique.
Outcome measures
| Measure |
Dose Exploration: Cohort 1
n=7 Participants
Participants received irinotecan liposome injection 70 mg/m\^2 followed by oxaliplatin 60 mg/m\^2 followed by LV 400 mg/m\^2 and then 5-FU 2400 mg/m\^2 IV infusion on Days 1 and 15 of each 28-day cycle until disease progression, death, unacceptable study treatment-related toxicity or withdrawal of consent.
|
Dose Exploration: Cohort -1
n=7 Participants
Participants received irinotecan liposome injection 50 mg/m\^2 followed by oxaliplatin 60 mg/m\^2 followed by LV 400 mg/m\^2 and then 5-FU 2400 mg/m\^2 IV infusion on Days 1 and 15 of each 28-day cycle until disease progression, death, unacceptable study treatment-related toxicity or withdrawal of consent.
|
Dose Exploration: Cohort -2B
n=10 Participants
Participants received irinotecan liposome injection 50 mg/m\^2 followed by oxaliplatin 85 mg/m\^2 followed by LV 400 mg/m\^2 and then 5-FU 2400 mg/m\^2 IV infusion on Days 1 and 15 of each 28-day cycle until disease progression, death, unacceptable study treatment-related toxicity or withdrawal of consent.
|
Dose Exploration: Cohort -3
n=7 Participants
Participants received irinotecan liposome injection 55 mg/m\^2 followed by oxaliplatin 70 mg/m\^2 followed by LV 400 mg/m\^2 and then 5-FU 2400 mg/m\^2 IV infusion on Days 1 and 15 of each 28-day cycle until disease progression, death, unacceptable study treatment-related toxicity or withdrawal of consent.
|
Dose Expansion: Cohort -1
n=25 Participants
Participants received irinotecan liposome injection 50 mg/m\^2 followed by oxaliplatin 60 mg/m\^2 followed by LV 400 mg/m\^2 and then 5-FU 2400 mg/m\^2 IV infusion on Days 1 and 15 of each 28-day cycle until disease progression, death, unacceptable study treatment-related toxicity or withdrawal of consent.
|
Cohort -1: Pooled
n=32 Participants
Participants received irinotecan liposome injection 50 mg/m\^2 followed by oxaliplatin 60 mg/m\^2 followed by LV 400 mg/m\^2 and then 5-FU 2400 mg/m\^2 IV infusion on Days 1 and 15 of each 28-day cycle until disease progression, death, unacceptable study treatment-related toxicity or withdrawal of consent.
|
|---|---|---|---|---|---|---|
|
Median Progression Free Survival (PFS)
|
9.7 months
Interval 2.96 to
Upper limit of confidence interval was not evaluable due to below the level of detection.
|
32.3 months
Interval 0.53 to
Upper limit of confidence interval was not evaluable due to below the level of detection.
|
9.2 months
Interval 0.46 to
Upper limit of confidence interval was not evaluable due to below the level of detection.
|
3.8 months
Interval 1.22 to 5.78
|
9.2 months
Interval 7.59 to 11.2
|
9.2 months
Interval 7.59 to 11.96
|
SECONDARY outcome
Timeframe: RECIST assessments performed at baseline (within 28 days before start of study treatment), every 8 weeks after first dose, EoT visit, then every 2 months thereafter (maximum of 278 weeks).Population: Safety population included participants who received at least 1 dose of any study treatment.
The BOR was defined as the best response (complete response \[CR\] + partial response \[PR\] + stable disease \[SD\]) recorded from the start of study treatment until disease progression or start of new anticancer therapy using RECIST Version 1.1.
Outcome measures
| Measure |
Dose Exploration: Cohort 1
n=7 Participants
Participants received irinotecan liposome injection 70 mg/m\^2 followed by oxaliplatin 60 mg/m\^2 followed by LV 400 mg/m\^2 and then 5-FU 2400 mg/m\^2 IV infusion on Days 1 and 15 of each 28-day cycle until disease progression, death, unacceptable study treatment-related toxicity or withdrawal of consent.
|
Dose Exploration: Cohort -1
n=7 Participants
Participants received irinotecan liposome injection 50 mg/m\^2 followed by oxaliplatin 60 mg/m\^2 followed by LV 400 mg/m\^2 and then 5-FU 2400 mg/m\^2 IV infusion on Days 1 and 15 of each 28-day cycle until disease progression, death, unacceptable study treatment-related toxicity or withdrawal of consent.
|
Dose Exploration: Cohort -2B
n=10 Participants
Participants received irinotecan liposome injection 50 mg/m\^2 followed by oxaliplatin 85 mg/m\^2 followed by LV 400 mg/m\^2 and then 5-FU 2400 mg/m\^2 IV infusion on Days 1 and 15 of each 28-day cycle until disease progression, death, unacceptable study treatment-related toxicity or withdrawal of consent.
|
Dose Exploration: Cohort -3
n=7 Participants
Participants received irinotecan liposome injection 55 mg/m\^2 followed by oxaliplatin 70 mg/m\^2 followed by LV 400 mg/m\^2 and then 5-FU 2400 mg/m\^2 IV infusion on Days 1 and 15 of each 28-day cycle until disease progression, death, unacceptable study treatment-related toxicity or withdrawal of consent.
|
Dose Expansion: Cohort -1
n=25 Participants
Participants received irinotecan liposome injection 50 mg/m\^2 followed by oxaliplatin 60 mg/m\^2 followed by LV 400 mg/m\^2 and then 5-FU 2400 mg/m\^2 IV infusion on Days 1 and 15 of each 28-day cycle until disease progression, death, unacceptable study treatment-related toxicity or withdrawal of consent.
|
Cohort -1: Pooled
n=32 Participants
Participants received irinotecan liposome injection 50 mg/m\^2 followed by oxaliplatin 60 mg/m\^2 followed by LV 400 mg/m\^2 and then 5-FU 2400 mg/m\^2 IV infusion on Days 1 and 15 of each 28-day cycle until disease progression, death, unacceptable study treatment-related toxicity or withdrawal of consent.
|
|---|---|---|---|---|---|---|
|
Best Overall Response (BOR)
|
2 Participants
|
6 Participants
|
4 Participants
|
4 Participants
|
20 Participants
|
26 Participants
|
SECONDARY outcome
Timeframe: RECIST assessments performed at baseline (within 28 days before start of study treatment), every 8 weeks after first dose, EoT visit, then every 2 months thereafter (maximum of 278 weeks).Population: Safety population included participants who received at least 1 dose of any study treatment.
The ORR was defined as the percentage of participants with a BOR characterized as either a CR or PR relative to the total number of evaluable participants using RECIST Version 1.1. Evaluable participants were defined as treated participants with measurable disease at baseline.
Outcome measures
| Measure |
Dose Exploration: Cohort 1
n=7 Participants
Participants received irinotecan liposome injection 70 mg/m\^2 followed by oxaliplatin 60 mg/m\^2 followed by LV 400 mg/m\^2 and then 5-FU 2400 mg/m\^2 IV infusion on Days 1 and 15 of each 28-day cycle until disease progression, death, unacceptable study treatment-related toxicity or withdrawal of consent.
|
Dose Exploration: Cohort -1
n=7 Participants
Participants received irinotecan liposome injection 50 mg/m\^2 followed by oxaliplatin 60 mg/m\^2 followed by LV 400 mg/m\^2 and then 5-FU 2400 mg/m\^2 IV infusion on Days 1 and 15 of each 28-day cycle until disease progression, death, unacceptable study treatment-related toxicity or withdrawal of consent.
|
Dose Exploration: Cohort -2B
n=10 Participants
Participants received irinotecan liposome injection 50 mg/m\^2 followed by oxaliplatin 85 mg/m\^2 followed by LV 400 mg/m\^2 and then 5-FU 2400 mg/m\^2 IV infusion on Days 1 and 15 of each 28-day cycle until disease progression, death, unacceptable study treatment-related toxicity or withdrawal of consent.
|
Dose Exploration: Cohort -3
n=7 Participants
Participants received irinotecan liposome injection 55 mg/m\^2 followed by oxaliplatin 70 mg/m\^2 followed by LV 400 mg/m\^2 and then 5-FU 2400 mg/m\^2 IV infusion on Days 1 and 15 of each 28-day cycle until disease progression, death, unacceptable study treatment-related toxicity or withdrawal of consent.
|
Dose Expansion: Cohort -1
n=25 Participants
Participants received irinotecan liposome injection 50 mg/m\^2 followed by oxaliplatin 60 mg/m\^2 followed by LV 400 mg/m\^2 and then 5-FU 2400 mg/m\^2 IV infusion on Days 1 and 15 of each 28-day cycle until disease progression, death, unacceptable study treatment-related toxicity or withdrawal of consent.
|
Cohort -1: Pooled
n=32 Participants
Participants received irinotecan liposome injection 50 mg/m\^2 followed by oxaliplatin 60 mg/m\^2 followed by LV 400 mg/m\^2 and then 5-FU 2400 mg/m\^2 IV infusion on Days 1 and 15 of each 28-day cycle until disease progression, death, unacceptable study treatment-related toxicity or withdrawal of consent.
|
|---|---|---|---|---|---|---|
|
Overall Response Rate (ORR)
|
0 percentage of participants
Interval 0.0 to 41.0
|
42.9 percentage of participants
Interval 9.9 to 81.6
|
30.0 percentage of participants
Interval 6.7 to 65.2
|
14.3 percentage of participants
Interval 0.4 to 57.9
|
32.0 percentage of participants
Interval 14.9 to 53.5
|
34.4 percentage of participants
Interval 18.6 to 53.2
|
SECONDARY outcome
Timeframe: At Week 16Population: Safety population included participants who received at least 1 dose of any study treatment.
The DCR was defined as percentage of participants with CR or PR or SD or Non-PD/Non-CR, per RECIST Version 1.1 relative to total number of treated participants with measurable disease at baseline.
Outcome measures
| Measure |
Dose Exploration: Cohort 1
n=7 Participants
Participants received irinotecan liposome injection 70 mg/m\^2 followed by oxaliplatin 60 mg/m\^2 followed by LV 400 mg/m\^2 and then 5-FU 2400 mg/m\^2 IV infusion on Days 1 and 15 of each 28-day cycle until disease progression, death, unacceptable study treatment-related toxicity or withdrawal of consent.
|
Dose Exploration: Cohort -1
n=7 Participants
Participants received irinotecan liposome injection 50 mg/m\^2 followed by oxaliplatin 60 mg/m\^2 followed by LV 400 mg/m\^2 and then 5-FU 2400 mg/m\^2 IV infusion on Days 1 and 15 of each 28-day cycle until disease progression, death, unacceptable study treatment-related toxicity or withdrawal of consent.
|
Dose Exploration: Cohort -2B
n=10 Participants
Participants received irinotecan liposome injection 50 mg/m\^2 followed by oxaliplatin 85 mg/m\^2 followed by LV 400 mg/m\^2 and then 5-FU 2400 mg/m\^2 IV infusion on Days 1 and 15 of each 28-day cycle until disease progression, death, unacceptable study treatment-related toxicity or withdrawal of consent.
|
Dose Exploration: Cohort -3
n=7 Participants
Participants received irinotecan liposome injection 55 mg/m\^2 followed by oxaliplatin 70 mg/m\^2 followed by LV 400 mg/m\^2 and then 5-FU 2400 mg/m\^2 IV infusion on Days 1 and 15 of each 28-day cycle until disease progression, death, unacceptable study treatment-related toxicity or withdrawal of consent.
|
Dose Expansion: Cohort -1
n=25 Participants
Participants received irinotecan liposome injection 50 mg/m\^2 followed by oxaliplatin 60 mg/m\^2 followed by LV 400 mg/m\^2 and then 5-FU 2400 mg/m\^2 IV infusion on Days 1 and 15 of each 28-day cycle until disease progression, death, unacceptable study treatment-related toxicity or withdrawal of consent.
|
Cohort -1: Pooled
n=32 Participants
Participants received irinotecan liposome injection 50 mg/m\^2 followed by oxaliplatin 60 mg/m\^2 followed by LV 400 mg/m\^2 and then 5-FU 2400 mg/m\^2 IV infusion on Days 1 and 15 of each 28-day cycle until disease progression, death, unacceptable study treatment-related toxicity or withdrawal of consent.
|
|---|---|---|---|---|---|---|
|
Disease Control Rate (DCR)
|
42.9 percentage of participants
Interval 9.9 to 81.6
|
71.4 percentage of participants
Interval 29.0 to 96.3
|
40.0 percentage of participants
Interval 12.2 to 73.8
|
28.6 percentage of participants
Interval 3.7 to 71.0
|
72.0 percentage of participants
Interval 50.6 to 87.9
|
71.9 percentage of participants
Interval 53.3 to 86.3
|
SECONDARY outcome
Timeframe: RECIST assessments performed at baseline (within 28 days before start of study treatment), every 8 weeks after first dose, EoT visit, then every 2 months thereafter (maximum of 278 weeks).Population: Safety population included participants who received at least 1 dose of any study treatment.
The OS was the time from date of first study treatment to the date of death from any cause. Participant survival data were collected from all available sources. The OS was calculated using Kaplan-Meier technique.
Outcome measures
| Measure |
Dose Exploration: Cohort 1
n=7 Participants
Participants received irinotecan liposome injection 70 mg/m\^2 followed by oxaliplatin 60 mg/m\^2 followed by LV 400 mg/m\^2 and then 5-FU 2400 mg/m\^2 IV infusion on Days 1 and 15 of each 28-day cycle until disease progression, death, unacceptable study treatment-related toxicity or withdrawal of consent.
|
Dose Exploration: Cohort -1
n=7 Participants
Participants received irinotecan liposome injection 50 mg/m\^2 followed by oxaliplatin 60 mg/m\^2 followed by LV 400 mg/m\^2 and then 5-FU 2400 mg/m\^2 IV infusion on Days 1 and 15 of each 28-day cycle until disease progression, death, unacceptable study treatment-related toxicity or withdrawal of consent.
|
Dose Exploration: Cohort -2B
n=10 Participants
Participants received irinotecan liposome injection 50 mg/m\^2 followed by oxaliplatin 85 mg/m\^2 followed by LV 400 mg/m\^2 and then 5-FU 2400 mg/m\^2 IV infusion on Days 1 and 15 of each 28-day cycle until disease progression, death, unacceptable study treatment-related toxicity or withdrawal of consent.
|
Dose Exploration: Cohort -3
n=7 Participants
Participants received irinotecan liposome injection 55 mg/m\^2 followed by oxaliplatin 70 mg/m\^2 followed by LV 400 mg/m\^2 and then 5-FU 2400 mg/m\^2 IV infusion on Days 1 and 15 of each 28-day cycle until disease progression, death, unacceptable study treatment-related toxicity or withdrawal of consent.
|
Dose Expansion: Cohort -1
n=25 Participants
Participants received irinotecan liposome injection 50 mg/m\^2 followed by oxaliplatin 60 mg/m\^2 followed by LV 400 mg/m\^2 and then 5-FU 2400 mg/m\^2 IV infusion on Days 1 and 15 of each 28-day cycle until disease progression, death, unacceptable study treatment-related toxicity or withdrawal of consent.
|
Cohort -1: Pooled
n=32 Participants
Participants received irinotecan liposome injection 50 mg/m\^2 followed by oxaliplatin 60 mg/m\^2 followed by LV 400 mg/m\^2 and then 5-FU 2400 mg/m\^2 IV infusion on Days 1 and 15 of each 28-day cycle until disease progression, death, unacceptable study treatment-related toxicity or withdrawal of consent.
|
|---|---|---|---|---|---|---|
|
Median Overall Survival (OS)
|
12.6 months
Interval 3.98 to 21.03
|
12.5 months
Interval 0.53 to 12.71
|
16.6 months
Interval 0.69 to 26.74
|
5.8 months
Interval 1.35 to 14.65
|
12.7 months
Interval 8.18 to 23.66
|
12.6 months
Interval 8.74 to 19.12
|
SECONDARY outcome
Timeframe: RECIST assessments performed at baseline (within 28 days before start of study treatment), every 8 weeks after first dose, EoT visit, then every 2 months thereafter (maximum of 278 weeks).Population: Safety population included participants who received at least 1 dose of any study treatment. Only participants with DoR events were analyzed for this outcome measure.
The DoR was defined as the time from the first date of response (CR or PR) to first date of documented radiographical PD, per investigator using RECIST Version 1.1. This only applied to participants with CR or PR. If a participant was given a new anticancer therapy prior to first response, DoR was not calculated. The DoR was calculated using Kaplan-Meier technique.
Outcome measures
| Measure |
Dose Exploration: Cohort 1
Participants received irinotecan liposome injection 70 mg/m\^2 followed by oxaliplatin 60 mg/m\^2 followed by LV 400 mg/m\^2 and then 5-FU 2400 mg/m\^2 IV infusion on Days 1 and 15 of each 28-day cycle until disease progression, death, unacceptable study treatment-related toxicity or withdrawal of consent.
|
Dose Exploration: Cohort -1
n=2 Participants
Participants received irinotecan liposome injection 50 mg/m\^2 followed by oxaliplatin 60 mg/m\^2 followed by LV 400 mg/m\^2 and then 5-FU 2400 mg/m\^2 IV infusion on Days 1 and 15 of each 28-day cycle until disease progression, death, unacceptable study treatment-related toxicity or withdrawal of consent.
|
Dose Exploration: Cohort -2B
n=1 Participants
Participants received irinotecan liposome injection 50 mg/m\^2 followed by oxaliplatin 85 mg/m\^2 followed by LV 400 mg/m\^2 and then 5-FU 2400 mg/m\^2 IV infusion on Days 1 and 15 of each 28-day cycle until disease progression, death, unacceptable study treatment-related toxicity or withdrawal of consent.
|
Dose Exploration: Cohort -3
Participants received irinotecan liposome injection 55 mg/m\^2 followed by oxaliplatin 70 mg/m\^2 followed by LV 400 mg/m\^2 and then 5-FU 2400 mg/m\^2 IV infusion on Days 1 and 15 of each 28-day cycle until disease progression, death, unacceptable study treatment-related toxicity or withdrawal of consent.
|
Dose Expansion: Cohort -1
n=4 Participants
Participants received irinotecan liposome injection 50 mg/m\^2 followed by oxaliplatin 60 mg/m\^2 followed by LV 400 mg/m\^2 and then 5-FU 2400 mg/m\^2 IV infusion on Days 1 and 15 of each 28-day cycle until disease progression, death, unacceptable study treatment-related toxicity or withdrawal of consent.
|
Cohort -1: Pooled
n=6 Participants
Participants received irinotecan liposome injection 50 mg/m\^2 followed by oxaliplatin 60 mg/m\^2 followed by LV 400 mg/m\^2 and then 5-FU 2400 mg/m\^2 IV infusion on Days 1 and 15 of each 28-day cycle until disease progression, death, unacceptable study treatment-related toxicity or withdrawal of consent.
|
|---|---|---|---|---|---|---|
|
Median Duration of Response (DoR)
|
—
|
28.4 months
Interval 3.52 to
Upper limit of confidence interval was not evaluable due to below the level of detection.
|
NA months
Interval to 16.39
Median and lower limit of confidence interval was not evaluable due to below the level of detection.
|
—
|
9.4 months
Interval 2.2 to
Upper limit of confidence interval was not evaluable due to below the level of detection.
|
9.4 months
Interval 3.52 to
Upper limit of confidence interval was not evaluable due to below the level of detection.
|
Adverse Events
Dose Exploration: Cohort 1
Serious events: 6 serious events
Other events: 7 other events
Deaths: 5 deaths
Dose Exploration: Cohort -1
Serious events: 2 serious events
Other events: 7 other events
Deaths: 7 deaths
Dose Exploration: Cohort -2B
Serious events: 7 serious events
Other events: 10 other events
Deaths: 8 deaths
Dose Exploration: Cohort -3
Serious events: 4 serious events
Other events: 7 other events
Deaths: 7 deaths
Dose Expansion: Cohort -1
Serious events: 15 serious events
Other events: 25 other events
Deaths: 17 deaths
Serious adverse events
| Measure |
Dose Exploration: Cohort 1
n=7 participants at risk
Participants received irinotecan liposome injection 70 mg/m\^2 followed by oxaliplatin 60 mg/m\^2 followed by LV 400 mg/m\^2 and then 5-FU 2400 mg/m\^2 IV infusion on Days 1 and 15 of each 28-day cycle until disease progression, death, unacceptable study treatment-related toxicity or withdrawal of consent.
|
Dose Exploration: Cohort -1
n=7 participants at risk
Participants received irinotecan liposome injection 50 mg/m\^2 followed by oxaliplatin 60 mg/m\^2 followed by LV 400 mg/m\^2 and then 5-FU 2400 mg/m\^2 IV infusion on Days 1 and 15 of each 28-day cycle until disease progression, death, unacceptable study treatment-related toxicity or withdrawal of consent.
|
Dose Exploration: Cohort -2B
n=10 participants at risk
Participants received irinotecan liposome injection 50 mg/m\^2 followed by oxaliplatin 85 mg/m\^2 followed by LV 400 mg/m\^2 and then 5-FU 2400 mg/m\^2 IV infusion on Days 1 and 15 of each 28-day cycle until disease progression, death, unacceptable study treatment-related toxicity or withdrawal of consent.
|
Dose Exploration: Cohort -3
n=7 participants at risk
Participants received irinotecan liposome injection 55 mg/m\^2 followed by oxaliplatin 70 mg/m\^2 followed by LV 400 mg/m\^2 and then 5-FU 2400 mg/m\^2 IV infusion on Days 1 and 15 of each 28-day cycle until disease progression, death, unacceptable study treatment-related toxicity or withdrawal of consent.
|
Dose Expansion: Cohort -1
n=25 participants at risk
Participants received irinotecan liposome injection 50 mg/m\^2 followed by oxaliplatin 60 mg/m\^2 followed by LV 400 mg/m\^2 and then 5-FU 2400 mg/m\^2 IV infusion on Days 1 and 15 of each 28-day cycle until disease progression, death, unacceptable study treatment-related toxicity or withdrawal of consent.
|
|---|---|---|---|---|---|
|
Gastrointestinal disorders
Diarrhoea
|
28.6%
2/7 • Number of events 2 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
14.3%
1/7 • Number of events 1 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
10.0%
1/10 • Number of events 1 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
14.3%
1/7 • Number of events 1 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
4.0%
1/25 • Number of events 2 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
|
Gastrointestinal disorders
Vomiting
|
14.3%
1/7 • Number of events 1 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
0.00%
0/7 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
20.0%
2/10 • Number of events 2 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
0.00%
0/7 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
12.0%
3/25 • Number of events 3 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
|
Gastrointestinal disorders
Abdominal Pain
|
0.00%
0/7 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
0.00%
0/7 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
0.00%
0/10 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
42.9%
3/7 • Number of events 3 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
4.0%
1/25 • Number of events 1 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/7 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
0.00%
0/7 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
10.0%
1/10 • Number of events 1 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
0.00%
0/7 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
12.0%
3/25 • Number of events 3 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
|
Gastrointestinal disorders
Colitis
|
0.00%
0/7 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
0.00%
0/7 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
0.00%
0/10 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
28.6%
2/7 • Number of events 2 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
4.0%
1/25 • Number of events 1 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
|
Gastrointestinal disorders
Enterocolitis
|
0.00%
0/7 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
0.00%
0/7 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
10.0%
1/10 • Number of events 1 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
0.00%
0/7 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
4.0%
1/25 • Number of events 1 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
|
Gastrointestinal disorders
Small Intestinal Obstruction
|
0.00%
0/7 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
0.00%
0/7 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
0.00%
0/10 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
14.3%
1/7 • Number of events 1 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
4.0%
1/25 • Number of events 2 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/7 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
0.00%
0/7 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
10.0%
1/10 • Number of events 1 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
0.00%
0/7 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
0.00%
0/25 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
|
Gastrointestinal disorders
Duodenal Ulcer
|
0.00%
0/7 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
0.00%
0/7 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
10.0%
1/10 • Number of events 1 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
0.00%
0/7 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
0.00%
0/25 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
|
Gastrointestinal disorders
Enteritis
|
14.3%
1/7 • Number of events 1 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
0.00%
0/7 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
0.00%
0/10 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
0.00%
0/7 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
0.00%
0/25 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
|
Gastrointestinal disorders
Intestinal Obstruction
|
0.00%
0/7 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
0.00%
0/7 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
0.00%
0/10 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
0.00%
0/7 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
4.0%
1/25 • Number of events 1 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
|
Gastrointestinal disorders
Large Intestinal Obstruction
|
14.3%
1/7 • Number of events 1 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
0.00%
0/7 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
0.00%
0/10 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
0.00%
0/7 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
0.00%
0/25 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
|
Gastrointestinal disorders
Malignant Gastrointestinal Obstruction
|
0.00%
0/7 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
0.00%
0/7 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
0.00%
0/10 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
0.00%
0/7 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
4.0%
1/25 • Number of events 1 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
|
Gastrointestinal disorders
Oesophageal Varices Haemorrhage
|
0.00%
0/7 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
0.00%
0/7 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
0.00%
0/10 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
0.00%
0/7 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
4.0%
1/25 • Number of events 1 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
|
Gastrointestinal disorders
Pancreatitis
|
0.00%
0/7 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
0.00%
0/7 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
0.00%
0/10 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
0.00%
0/7 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
4.0%
1/25 • Number of events 1 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
|
Gastrointestinal disorders
Stomatitis
|
0.00%
0/7 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
0.00%
0/7 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
0.00%
0/10 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
0.00%
0/7 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
4.0%
1/25 • Number of events 1 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
|
Gastrointestinal disorders
Upper Gastrointestinal Haemorrhage
|
0.00%
0/7 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
14.3%
1/7 • Number of events 1 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
0.00%
0/10 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
0.00%
0/7 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
0.00%
0/25 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
|
Blood and lymphatic system disorders
Febrile Neutropenia
|
0.00%
0/7 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
14.3%
1/7 • Number of events 1 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
0.00%
0/10 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
0.00%
0/7 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
8.0%
2/25 • Number of events 2 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/7 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
0.00%
0/7 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
0.00%
0/10 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
0.00%
0/7 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
4.0%
1/25 • Number of events 3 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
|
Blood and lymphatic system disorders
Anaemia of Malignant Disease
|
0.00%
0/7 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
0.00%
0/7 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
0.00%
0/10 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
14.3%
1/7 • Number of events 1 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
0.00%
0/25 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
|
Infections and infestations
Bacterial Sepsis
|
0.00%
0/7 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
0.00%
0/7 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
0.00%
0/10 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
0.00%
0/7 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
4.0%
1/25 • Number of events 1 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
|
Infections and infestations
Clostridium Difficile Colitis
|
14.3%
1/7 • Number of events 1 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
0.00%
0/7 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
0.00%
0/10 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
0.00%
0/7 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
0.00%
0/25 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
|
Infections and infestations
Neutropenic Sepsis
|
14.3%
1/7 • Number of events 1 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
0.00%
0/7 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
0.00%
0/10 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
0.00%
0/7 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
0.00%
0/25 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/7 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
0.00%
0/7 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
0.00%
0/10 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
0.00%
0/7 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
4.0%
1/25 • Number of events 1 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
|
Infections and infestations
Sepsis
|
0.00%
0/7 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
0.00%
0/7 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
0.00%
0/10 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
0.00%
0/7 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
4.0%
1/25 • Number of events 2 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
|
Infections and infestations
Urinary Tract Infection
|
0.00%
0/7 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
0.00%
0/7 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
0.00%
0/10 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
0.00%
0/7 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
4.0%
1/25 • Number of events 1 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
|
Metabolism and nutrition disorders
Dehydration
|
14.3%
1/7 • Number of events 1 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
0.00%
0/7 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
10.0%
1/10 • Number of events 1 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
0.00%
0/7 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
0.00%
0/25 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/7 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
0.00%
0/7 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
0.00%
0/10 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
0.00%
0/7 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
4.0%
1/25 • Number of events 1 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/7 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
0.00%
0/7 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
0.00%
0/10 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
14.3%
1/7 • Number of events 1 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
0.00%
0/25 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
|
General disorders
Disease Progression
|
0.00%
0/7 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
0.00%
0/7 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
0.00%
0/10 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
0.00%
0/7 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
4.0%
1/25 • Number of events 1 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
|
General disorders
Fatigue
|
0.00%
0/7 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
0.00%
0/7 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
0.00%
0/10 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
14.3%
1/7 • Number of events 1 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
0.00%
0/25 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
|
General disorders
Pyrexia
|
0.00%
0/7 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
0.00%
0/7 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
0.00%
0/10 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
0.00%
0/7 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
4.0%
1/25 • Number of events 1 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
|
Hepatobiliary disorders
Bile Duct Obstruction
|
0.00%
0/7 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
0.00%
0/7 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
0.00%
0/10 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
0.00%
0/7 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
4.0%
1/25 • Number of events 1 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
|
Hepatobiliary disorders
Biliary Dilatation
|
0.00%
0/7 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
0.00%
0/7 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
0.00%
0/10 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
0.00%
0/7 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
4.0%
1/25 • Number of events 1 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
|
Hepatobiliary disorders
Cholangitis
|
0.00%
0/7 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
0.00%
0/7 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
0.00%
0/10 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
0.00%
0/7 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
4.0%
1/25 • Number of events 1 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Embolism
|
0.00%
0/7 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
0.00%
0/7 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
0.00%
0/10 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
14.3%
1/7 • Number of events 1 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
4.0%
1/25 • Number of events 1 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/7 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
0.00%
0/7 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
0.00%
0/10 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
0.00%
0/7 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
4.0%
1/25 • Number of events 1 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
|
Vascular disorders
Deep Vein Thrombosis
|
0.00%
0/7 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
0.00%
0/7 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
0.00%
0/10 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
0.00%
0/7 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
4.0%
1/25 • Number of events 1 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
|
Vascular disorders
Hypotension
|
0.00%
0/7 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
0.00%
0/7 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
10.0%
1/10 • Number of events 1 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
0.00%
0/7 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
0.00%
0/25 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
|
Vascular disorders
Orthostatic Hypotension
|
14.3%
1/7 • Number of events 1 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
0.00%
0/7 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
0.00%
0/10 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
0.00%
0/7 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
0.00%
0/25 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
|
Renal and urinary disorders
Acute Kidney Injury
|
0.00%
0/7 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
0.00%
0/7 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
0.00%
0/10 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
14.3%
1/7 • Number of events 1 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
0.00%
0/25 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.00%
0/7 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
0.00%
0/7 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
0.00%
0/10 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
0.00%
0/7 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
4.0%
1/25 • Number of events 1 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
|
Cardiac disorders
Arteriospasm Coronary
|
0.00%
0/7 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
0.00%
0/7 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
10.0%
1/10 • Number of events 1 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
0.00%
0/7 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
0.00%
0/25 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
|
Injury, poisoning and procedural complications
Subdural Haematoma
|
0.00%
0/7 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
0.00%
0/7 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
10.0%
1/10 • Number of events 1 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
0.00%
0/7 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
0.00%
0/25 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
0.00%
0/7 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
0.00%
0/7 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
0.00%
0/10 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
0.00%
0/7 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
4.0%
1/25 • Number of events 1 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
Other adverse events
| Measure |
Dose Exploration: Cohort 1
n=7 participants at risk
Participants received irinotecan liposome injection 70 mg/m\^2 followed by oxaliplatin 60 mg/m\^2 followed by LV 400 mg/m\^2 and then 5-FU 2400 mg/m\^2 IV infusion on Days 1 and 15 of each 28-day cycle until disease progression, death, unacceptable study treatment-related toxicity or withdrawal of consent.
|
Dose Exploration: Cohort -1
n=7 participants at risk
Participants received irinotecan liposome injection 50 mg/m\^2 followed by oxaliplatin 60 mg/m\^2 followed by LV 400 mg/m\^2 and then 5-FU 2400 mg/m\^2 IV infusion on Days 1 and 15 of each 28-day cycle until disease progression, death, unacceptable study treatment-related toxicity or withdrawal of consent.
|
Dose Exploration: Cohort -2B
n=10 participants at risk
Participants received irinotecan liposome injection 50 mg/m\^2 followed by oxaliplatin 85 mg/m\^2 followed by LV 400 mg/m\^2 and then 5-FU 2400 mg/m\^2 IV infusion on Days 1 and 15 of each 28-day cycle until disease progression, death, unacceptable study treatment-related toxicity or withdrawal of consent.
|
Dose Exploration: Cohort -3
n=7 participants at risk
Participants received irinotecan liposome injection 55 mg/m\^2 followed by oxaliplatin 70 mg/m\^2 followed by LV 400 mg/m\^2 and then 5-FU 2400 mg/m\^2 IV infusion on Days 1 and 15 of each 28-day cycle until disease progression, death, unacceptable study treatment-related toxicity or withdrawal of consent.
|
Dose Expansion: Cohort -1
n=25 participants at risk
Participants received irinotecan liposome injection 50 mg/m\^2 followed by oxaliplatin 60 mg/m\^2 followed by LV 400 mg/m\^2 and then 5-FU 2400 mg/m\^2 IV infusion on Days 1 and 15 of each 28-day cycle until disease progression, death, unacceptable study treatment-related toxicity or withdrawal of consent.
|
|---|---|---|---|---|---|
|
Gastrointestinal disorders
Dysphagia
|
14.3%
1/7 • Number of events 1 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
0.00%
0/7 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
0.00%
0/10 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
14.3%
1/7 • Number of events 1 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
0.00%
0/25 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
|
Gastrointestinal disorders
Enterocolitis
|
0.00%
0/7 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
0.00%
0/7 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
10.0%
1/10 • Number of events 1 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
0.00%
0/7 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
4.0%
1/25 • Number of events 1 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
|
Gastrointestinal disorders
Nausea
|
71.4%
5/7 • Number of events 9 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
85.7%
6/7 • Number of events 7 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
90.0%
9/10 • Number of events 19 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
71.4%
5/7 • Number of events 6 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
92.0%
23/25 • Number of events 49 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
|
Gastrointestinal disorders
Diarrhoea
|
85.7%
6/7 • Number of events 18 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
71.4%
5/7 • Number of events 22 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
60.0%
6/10 • Number of events 14 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
85.7%
6/7 • Number of events 14 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
88.0%
22/25 • Number of events 54 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
|
Gastrointestinal disorders
Vomiting
|
71.4%
5/7 • Number of events 12 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
57.1%
4/7 • Number of events 7 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
50.0%
5/10 • Number of events 8 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
42.9%
3/7 • Number of events 4 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
56.0%
14/25 • Number of events 28 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
|
Investigations
Platelet count decreased
|
14.3%
1/7 • Number of events 2 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
14.3%
1/7 • Number of events 2 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
10.0%
1/10 • Number of events 2 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
0.00%
0/7 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
20.0%
5/25 • Number of events 17 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
|
Gastrointestinal disorders
Constipation
|
42.9%
3/7 • Number of events 3 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
57.1%
4/7 • Number of events 9 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
40.0%
4/10 • Number of events 5 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
14.3%
1/7 • Number of events 2 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
52.0%
13/25 • Number of events 22 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
|
Gastrointestinal disorders
Abdominal pain
|
28.6%
2/7 • Number of events 5 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
42.9%
3/7 • Number of events 5 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
30.0%
3/10 • Number of events 3 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
57.1%
4/7 • Number of events 6 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
32.0%
8/25 • Number of events 16 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
|
Gastrointestinal disorders
Stomatitis
|
0.00%
0/7 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
14.3%
1/7 • Number of events 1 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
20.0%
2/10 • Number of events 7 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
14.3%
1/7 • Number of events 1 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
28.0%
7/25 • Number of events 9 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
|
Gastrointestinal disorders
Abdominal distension
|
42.9%
3/7 • Number of events 3 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
28.6%
2/7 • Number of events 2 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
20.0%
2/10 • Number of events 2 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
0.00%
0/7 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
12.0%
3/25 • Number of events 3 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
|
Gastrointestinal disorders
Dry mouth
|
28.6%
2/7 • Number of events 4 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
14.3%
1/7 • Number of events 1 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
10.0%
1/10 • Number of events 1 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
42.9%
3/7 • Number of events 3 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
12.0%
3/25 • Number of events 3 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
|
Gastrointestinal disorders
Flatulence
|
0.00%
0/7 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
57.1%
4/7 • Number of events 5 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
20.0%
2/10 • Number of events 2 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
14.3%
1/7 • Number of events 1 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
4.0%
1/25 • Number of events 1 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
28.6%
2/7 • Number of events 2 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
14.3%
1/7 • Number of events 1 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
10.0%
1/10 • Number of events 1 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
0.00%
0/7 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
8.0%
2/25 • Number of events 2 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
|
Gastrointestinal disorders
Haemorrhoids
|
14.3%
1/7 • Number of events 1 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
28.6%
2/7 • Number of events 3 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
0.00%
0/10 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
14.3%
1/7 • Number of events 1 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
8.0%
2/25 • Number of events 2 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
|
Gastrointestinal disorders
Pancreatic failure
|
0.00%
0/7 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
42.9%
3/7 • Number of events 3 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
0.00%
0/10 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
14.3%
1/7 • Number of events 1 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
4.0%
1/25 • Number of events 1 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
|
Gastrointestinal disorders
Colitis
|
14.3%
1/7 • Number of events 1 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
0.00%
0/7 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
0.00%
0/10 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
28.6%
2/7 • Number of events 3 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
4.0%
1/25 • Number of events 1 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/7 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
0.00%
0/7 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
0.00%
0/10 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
0.00%
0/7 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
16.0%
4/25 • Number of events 6 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
|
Gastrointestinal disorders
Anal fissure
|
0.00%
0/7 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
14.3%
1/7 • Number of events 1 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
20.0%
2/10 • Number of events 3 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
0.00%
0/7 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
0.00%
0/25 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
14.3%
1/7 • Number of events 1 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
0.00%
0/7 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
0.00%
0/10 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
14.3%
1/7 • Number of events 1 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
4.0%
1/25 • Number of events 2 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
|
Gastrointestinal disorders
Toothache
|
0.00%
0/7 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
14.3%
1/7 • Number of events 1 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
0.00%
0/10 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
0.00%
0/7 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
8.0%
2/25 • Number of events 2 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
|
Gastrointestinal disorders
Anal haemorrhage
|
0.00%
0/7 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
0.00%
0/7 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
10.0%
1/10 • Number of events 1 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
14.3%
1/7 • Number of events 1 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
0.00%
0/25 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.00%
0/7 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
28.6%
2/7 • Number of events 3 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
0.00%
0/10 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
0.00%
0/7 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
0.00%
0/25 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
|
Gastrointestinal disorders
Mouth ulceration
|
0.00%
0/7 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
28.6%
2/7 • Number of events 2 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
0.00%
0/10 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
0.00%
0/7 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
0.00%
0/25 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
|
Gastrointestinal disorders
Proctalgia
|
0.00%
0/7 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
0.00%
0/7 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
20.0%
2/10 • Number of events 4 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
0.00%
0/7 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
0.00%
0/25 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
|
Gastrointestinal disorders
Abdominal pain lower
|
0.00%
0/7 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
0.00%
0/7 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
0.00%
0/10 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
0.00%
0/7 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
4.0%
1/25 • Number of events 1 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
|
Gastrointestinal disorders
Abdominal rigidity
|
0.00%
0/7 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
0.00%
0/7 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
0.00%
0/10 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
0.00%
0/7 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
4.0%
1/25 • Number of events 4 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
|
Gastrointestinal disorders
Anal incontinence
|
14.3%
1/7 • Number of events 1 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
0.00%
0/7 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
0.00%
0/10 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
0.00%
0/7 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
0.00%
0/25 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
|
Gastrointestinal disorders
Anal inflammation
|
0.00%
0/7 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
0.00%
0/7 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
10.0%
1/10 • Number of events 1 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
0.00%
0/7 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
0.00%
0/25 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
|
Gastrointestinal disorders
Angular cheilitis
|
0.00%
0/7 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
0.00%
0/7 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
10.0%
1/10 • Number of events 1 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
0.00%
0/7 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
0.00%
0/25 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
|
Gastrointestinal disorders
Ascites
|
0.00%
0/7 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
0.00%
0/7 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
10.0%
1/10 • Number of events 2 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
0.00%
0/7 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
0.00%
0/25 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
|
General disorders
Axillary pain
|
0.00%
0/7 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
0.00%
0/7 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
0.00%
0/10 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
0.00%
0/7 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
4.0%
1/25 • Number of events 1 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
|
Gastrointestinal disorders
Duodenal ulcer
|
0.00%
0/7 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
0.00%
0/7 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
10.0%
1/10 • Number of events 2 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
0.00%
0/7 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
0.00%
0/25 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
|
Gastrointestinal disorders
Enteritis
|
14.3%
1/7 • Number of events 1 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
0.00%
0/7 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
0.00%
0/10 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
0.00%
0/7 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
0.00%
0/25 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
|
Gastrointestinal disorders
Epigastric discomfort
|
0.00%
0/7 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
14.3%
1/7 • Number of events 2 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
0.00%
0/10 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
0.00%
0/7 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
0.00%
0/25 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
|
Gastrointestinal disorders
Eructation
|
0.00%
0/7 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
14.3%
1/7 • Number of events 1 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
0.00%
0/10 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
0.00%
0/7 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
0.00%
0/25 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
|
Gastrointestinal disorders
Faeces discoloured
|
0.00%
0/7 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
0.00%
0/7 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
0.00%
0/10 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
0.00%
0/7 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
4.0%
1/25 • Number of events 1 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
|
Gastrointestinal disorders
Gastritis
|
14.3%
1/7 • Number of events 1 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
0.00%
0/7 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
0.00%
0/10 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
0.00%
0/7 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
0.00%
0/25 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
|
Gastrointestinal disorders
Gastrointestinal oedema
|
14.3%
1/7 • Number of events 1 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
0.00%
0/7 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
0.00%
0/10 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
0.00%
0/7 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
0.00%
0/25 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
|
Gastrointestinal disorders
Haematemesis
|
0.00%
0/7 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
0.00%
0/7 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
0.00%
0/10 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
0.00%
0/7 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
4.0%
1/25 • Number of events 1 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
|
Gastrointestinal disorders
Intestinal obstruction
|
0.00%
0/7 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
0.00%
0/7 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
0.00%
0/10 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
0.00%
0/7 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
4.0%
1/25 • Number of events 1 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
|
Gastrointestinal disorders
Large intestinal obstruction
|
14.3%
1/7 • Number of events 1 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
0.00%
0/7 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
0.00%
0/10 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
0.00%
0/7 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
0.00%
0/25 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
|
Gastrointestinal disorders
Large intestine perforation
|
14.3%
1/7 • Number of events 1 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
0.00%
0/7 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
0.00%
0/10 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
0.00%
0/7 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
0.00%
0/25 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
|
General disorders
Temperature intolerance
|
0.00%
0/7 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
0.00%
0/7 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
0.00%
0/10 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
0.00%
0/7 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
8.0%
2/25 • Number of events 2 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
|
Gastrointestinal disorders
Lower gastrointestinal haemorrhage
|
0.00%
0/7 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
0.00%
0/7 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
0.00%
0/10 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
0.00%
0/7 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
4.0%
1/25 • Number of events 1 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
|
Gastrointestinal disorders
Malignant gastrointestinal obstruction
|
0.00%
0/7 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
0.00%
0/7 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
0.00%
0/10 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
0.00%
0/7 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
4.0%
1/25 • Number of events 1 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
|
Gastrointestinal disorders
Odynophagia
|
14.3%
1/7 • Number of events 1 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
0.00%
0/7 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
0.00%
0/10 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
0.00%
0/7 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
0.00%
0/25 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
|
Gastrointestinal disorders
Oesophageal ulcer
|
0.00%
0/7 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
0.00%
0/7 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
0.00%
0/10 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
0.00%
0/7 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
4.0%
1/25 • Number of events 1 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
|
Gastrointestinal disorders
Oesophageal varices haemorrhage
|
0.00%
0/7 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
0.00%
0/7 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
0.00%
0/10 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
0.00%
0/7 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
4.0%
1/25 • Number of events 2 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
|
Gastrointestinal disorders
Oesophagitis
|
0.00%
0/7 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
0.00%
0/7 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
0.00%
0/10 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
0.00%
0/7 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
4.0%
1/25 • Number of events 1 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
|
Gastrointestinal disorders
Oral pain
|
0.00%
0/7 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
14.3%
1/7 • Number of events 1 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
0.00%
0/10 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
0.00%
0/7 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
0.00%
0/25 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
|
Gastrointestinal disorders
Pancreatitis
|
0.00%
0/7 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
0.00%
0/7 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
0.00%
0/10 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
0.00%
0/7 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
4.0%
1/25 • Number of events 1 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
0.00%
0/7 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
0.00%
0/7 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
0.00%
0/10 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
0.00%
0/7 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
4.0%
1/25 • Number of events 2 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
|
Gastrointestinal disorders
Steatorrhoea
|
0.00%
0/7 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
0.00%
0/7 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
0.00%
0/10 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
0.00%
0/7 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
4.0%
1/25 • Number of events 1 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
|
Gastrointestinal disorders
Tongue discolouration
|
14.3%
1/7 • Number of events 1 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
0.00%
0/7 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
0.00%
0/10 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
0.00%
0/7 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
0.00%
0/25 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
|
Gastrointestinal disorders
Upper gastrointestinal haemorrhage
|
0.00%
0/7 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
14.3%
1/7 • Number of events 1 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
0.00%
0/10 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
0.00%
0/7 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
0.00%
0/25 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
|
Gastrointestinal disorders
Varices oesophageal
|
0.00%
0/7 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
0.00%
0/7 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
0.00%
0/10 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
0.00%
0/7 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
4.0%
1/25 • Number of events 1 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
|
General disorders
Fatigue
|
71.4%
5/7 • Number of events 9 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
71.4%
5/7 • Number of events 10 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
70.0%
7/10 • Number of events 13 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
71.4%
5/7 • Number of events 6 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
64.0%
16/25 • Number of events 21 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
|
General disorders
Pyrexia
|
42.9%
3/7 • Number of events 3 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
14.3%
1/7 • Number of events 1 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
20.0%
2/10 • Number of events 2 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
14.3%
1/7 • Number of events 1 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
20.0%
5/25 • Number of events 14 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
|
General disorders
Asthenia
|
0.00%
0/7 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
0.00%
0/7 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
10.0%
1/10 • Number of events 1 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
14.3%
1/7 • Number of events 1 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
32.0%
8/25 • Number of events 15 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
|
General disorders
Oedema peripheral
|
42.9%
3/7 • Number of events 3 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
28.6%
2/7 • Number of events 2 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
10.0%
1/10 • Number of events 3 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
14.3%
1/7 • Number of events 1 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
8.0%
2/25 • Number of events 2 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
|
General disorders
Chills
|
28.6%
2/7 • Number of events 3 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
0.00%
0/7 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
10.0%
1/10 • Number of events 1 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
0.00%
0/7 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
4.0%
1/25 • Number of events 2 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
|
General disorders
Mucosal inflammation
|
0.00%
0/7 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
14.3%
1/7 • Number of events 1 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
0.00%
0/10 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
0.00%
0/7 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
12.0%
3/25 • Number of events 7 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
|
General disorders
Malaise
|
0.00%
0/7 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
28.6%
2/7 • Number of events 2 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
0.00%
0/10 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
0.00%
0/7 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
4.0%
1/25 • Number of events 1 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
|
General disorders
Catheter site erythema
|
0.00%
0/7 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
14.3%
1/7 • Number of events 1 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
0.00%
0/10 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
0.00%
0/7 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
0.00%
0/25 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
|
General disorders
Catheter site extravasation
|
14.3%
1/7 • Number of events 1 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
0.00%
0/7 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
0.00%
0/10 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
0.00%
0/7 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
0.00%
0/25 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
|
General disorders
Catheter site haemorrhage
|
14.3%
1/7 • Number of events 1 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
0.00%
0/7 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
0.00%
0/10 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
0.00%
0/7 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
0.00%
0/25 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
|
General disorders
Catheter site pain
|
14.3%
1/7 • Number of events 1 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
0.00%
0/7 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
0.00%
0/10 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
0.00%
0/7 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
0.00%
0/25 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
|
General disorders
Cyst
|
0.00%
0/7 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
14.3%
1/7 • Number of events 1 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
0.00%
0/10 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
0.00%
0/7 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
0.00%
0/25 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
|
General disorders
Disease progression
|
0.00%
0/7 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
0.00%
0/7 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
0.00%
0/10 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
0.00%
0/7 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
4.0%
1/25 • Number of events 1 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
|
General disorders
Localised oedema
|
0.00%
0/7 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
0.00%
0/7 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
0.00%
0/10 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
0.00%
0/7 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
4.0%
1/25 • Number of events 1 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/7 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
0.00%
0/7 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
0.00%
0/10 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
0.00%
0/7 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
4.0%
1/25 • Number of events 1 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
71.4%
5/7 • Number of events 10 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
85.7%
6/7 • Number of events 9 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
40.0%
4/10 • Number of events 8 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
42.9%
3/7 • Number of events 4 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
48.0%
12/25 • Number of events 15 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
57.1%
4/7 • Number of events 5 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
28.6%
2/7 • Number of events 3 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
50.0%
5/10 • Number of events 6 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
42.9%
3/7 • Number of events 11 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
48.0%
12/25 • Number of events 34 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
|
Metabolism and nutrition disorders
Dehydration
|
57.1%
4/7 • Number of events 5 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
42.9%
3/7 • Number of events 3 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
30.0%
3/10 • Number of events 4 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
28.6%
2/7 • Number of events 2 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
20.0%
5/25 • Number of events 7 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
42.9%
3/7 • Number of events 4 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
0.00%
0/7 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
20.0%
2/10 • Number of events 3 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
28.6%
2/7 • Number of events 2 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
16.0%
4/25 • Number of events 21 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
28.6%
2/7 • Number of events 4 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
0.00%
0/7 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
20.0%
2/10 • Number of events 3 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
14.3%
1/7 • Number of events 1 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
12.0%
3/25 • Number of events 9 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
0.00%
0/7 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
0.00%
0/7 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
20.0%
2/10 • Number of events 2 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
0.00%
0/7 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
8.0%
2/25 • Number of events 10 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/7 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
0.00%
0/7 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
10.0%
1/10 • Number of events 1 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
0.00%
0/7 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
8.0%
2/25 • Number of events 18 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/7 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
0.00%
0/7 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
0.00%
0/10 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
14.3%
1/7 • Number of events 1 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
8.0%
2/25 • Number of events 18 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
14.3%
1/7 • Number of events 1 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
14.3%
1/7 • Number of events 1 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
0.00%
0/10 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
14.3%
1/7 • Number of events 1 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
0.00%
0/25 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
|
Metabolism and nutrition disorders
Hyperphosphataemia
|
0.00%
0/7 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
0.00%
0/7 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
0.00%
0/10 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
0.00%
0/7 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
4.0%
1/25 • Number of events 1 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
|
Metabolism and nutrition disorders
Hypovolaemia
|
14.3%
1/7 • Number of events 1 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
0.00%
0/7 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
0.00%
0/10 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
0.00%
0/7 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
0.00%
0/25 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
|
Metabolism and nutrition disorders
Metabolic acidosis
|
14.3%
1/7 • Number of events 1 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
0.00%
0/7 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
0.00%
0/10 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
0.00%
0/7 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
0.00%
0/25 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
|
Nervous system disorders
Dizziness
|
28.6%
2/7 • Number of events 5 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
28.6%
2/7 • Number of events 2 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
30.0%
3/10 • Number of events 6 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
28.6%
2/7 • Number of events 2 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
32.0%
8/25 • Number of events 9 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
|
Nervous system disorders
Neuropathy peripheral
|
14.3%
1/7 • Number of events 1 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
42.9%
3/7 • Number of events 6 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
20.0%
2/10 • Number of events 3 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
28.6%
2/7 • Number of events 5 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
28.0%
7/25 • Number of events 11 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
|
Nervous system disorders
Dysgeusia
|
14.3%
1/7 • Number of events 2 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
28.6%
2/7 • Number of events 2 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
20.0%
2/10 • Number of events 2 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
28.6%
2/7 • Number of events 2 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
16.0%
4/25 • Number of events 5 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
|
Nervous system disorders
Headache
|
28.6%
2/7 • Number of events 2 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
14.3%
1/7 • Number of events 1 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
10.0%
1/10 • Number of events 1 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
0.00%
0/7 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
16.0%
4/25 • Number of events 4 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
28.6%
2/7 • Number of events 2 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
14.3%
1/7 • Number of events 1 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
30.0%
3/10 • Number of events 5 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
0.00%
0/7 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
8.0%
2/25 • Number of events 7 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
|
Nervous system disorders
Taste disorder
|
28.6%
2/7 • Number of events 2 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
0.00%
0/7 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
0.00%
0/10 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
0.00%
0/7 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
8.0%
2/25 • Number of events 2 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
|
Nervous system disorders
Lethargy
|
14.3%
1/7 • Number of events 1 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
0.00%
0/7 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
0.00%
0/10 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
0.00%
0/7 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
4.0%
1/25 • Number of events 1 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
|
Nervous system disorders
Neurotoxicity
|
0.00%
0/7 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
0.00%
0/7 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
0.00%
0/10 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
0.00%
0/7 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
8.0%
2/25 • Number of events 3 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
|
Nervous system disorders
Cognitive disorder
|
14.3%
1/7 • Number of events 1 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
0.00%
0/7 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
0.00%
0/10 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
0.00%
0/7 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
0.00%
0/25 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
|
Nervous system disorders
Dysaesthesia
|
0.00%
0/7 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
0.00%
0/7 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
0.00%
0/10 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
0.00%
0/7 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
4.0%
1/25 • Number of events 1 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
|
Nervous system disorders
Hyperaesthesia
|
0.00%
0/7 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
14.3%
1/7 • Number of events 1 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
0.00%
0/10 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
0.00%
0/7 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
0.00%
0/25 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
|
Nervous system disorders
Hypoaesthesia
|
0.00%
0/7 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
0.00%
0/7 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
0.00%
0/10 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
14.3%
1/7 • Number of events 1 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
0.00%
0/25 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
|
Nervous system disorders
Lhermitte's sign
|
0.00%
0/7 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
14.3%
1/7 • Number of events 2 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
0.00%
0/10 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
0.00%
0/7 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
0.00%
0/25 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
|
Nervous system disorders
Memory impairment
|
14.3%
1/7 • Number of events 2 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
0.00%
0/7 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
0.00%
0/10 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
0.00%
0/7 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
0.00%
0/25 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
|
Nervous system disorders
Syncope
|
0.00%
0/7 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
14.3%
1/7 • Number of events 1 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
0.00%
0/10 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
0.00%
0/7 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
0.00%
0/25 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
|
Blood and lymphatic system disorders
Neutropenia
|
28.6%
2/7 • Number of events 4 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
42.9%
3/7 • Number of events 13 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
50.0%
5/10 • Number of events 6 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
14.3%
1/7 • Number of events 2 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
40.0%
10/25 • Number of events 29 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/7 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
28.6%
2/7 • Number of events 10 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
40.0%
4/10 • Number of events 4 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
0.00%
0/7 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
36.0%
9/25 • Number of events 18 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
|
Blood and lymphatic system disorders
Anaemia
|
14.3%
1/7 • Number of events 2 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
14.3%
1/7 • Number of events 1 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
30.0%
3/10 • Number of events 5 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
28.6%
2/7 • Number of events 2 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
28.0%
7/25 • Number of events 35 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
0.00%
0/7 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
14.3%
1/7 • Number of events 1 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
0.00%
0/10 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
0.00%
0/7 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
12.0%
3/25 • Number of events 4 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
|
Blood and lymphatic system disorders
Leukocytosis
|
0.00%
0/7 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
0.00%
0/7 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
0.00%
0/10 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
0.00%
0/7 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
12.0%
3/25 • Number of events 3 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
|
Blood and lymphatic system disorders
Leukopenia
|
0.00%
0/7 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
0.00%
0/7 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
10.0%
1/10 • Number of events 2 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
14.3%
1/7 • Number of events 1 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
4.0%
1/25 • Number of events 1 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
|
Blood and lymphatic system disorders
Neutrophilia
|
0.00%
0/7 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
0.00%
0/7 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
0.00%
0/10 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
0.00%
0/7 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
8.0%
2/25 • Number of events 2 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
|
Blood and lymphatic system disorders
Anaemia of malignant disease
|
0.00%
0/7 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
0.00%
0/7 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
0.00%
0/10 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
14.3%
1/7 • Number of events 1 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
0.00%
0/25 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
|
Blood and lymphatic system disorders
Cytopenia
|
0.00%
0/7 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
0.00%
0/7 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
0.00%
0/10 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
0.00%
0/7 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
4.0%
1/25 • Number of events 1 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
|
Blood and lymphatic system disorders
Splenic infarction
|
0.00%
0/7 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
0.00%
0/7 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
0.00%
0/10 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
0.00%
0/7 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
4.0%
1/25 • Number of events 1 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
|
Blood and lymphatic system disorders
Splenic vein thrombosis
|
0.00%
0/7 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
0.00%
0/7 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
0.00%
0/10 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
14.3%
1/7 • Number of events 1 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
0.00%
0/25 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
|
Investigations
Weight decreased
|
14.3%
1/7 • Number of events 2 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
28.6%
2/7 • Number of events 3 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
40.0%
4/10 • Number of events 6 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
28.6%
2/7 • Number of events 4 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
20.0%
5/25 • Number of events 7 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/7 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
0.00%
0/7 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
10.0%
1/10 • Number of events 1 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
14.3%
1/7 • Number of events 1 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
36.0%
9/25 • Number of events 17 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/7 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
0.00%
0/7 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
20.0%
2/10 • Number of events 2 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
0.00%
0/7 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
36.0%
9/25 • Number of events 15 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
|
Investigations
White blood cell count decreased
|
14.3%
1/7 • Number of events 1 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
14.3%
1/7 • Number of events 1 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
20.0%
2/10 • Number of events 2 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
0.00%
0/7 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
16.0%
4/25 • Number of events 10 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
|
Investigations
Neutrophil count decreased
|
14.3%
1/7 • Number of events 1 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
0.00%
0/7 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
10.0%
1/10 • Number of events 7 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
14.3%
1/7 • Number of events 1 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
16.0%
4/25 • Number of events 12 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
|
Vascular disorders
Hypotension
|
14.3%
1/7 • Number of events 1 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
0.00%
0/7 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
20.0%
2/10 • Number of events 3 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
14.3%
1/7 • Number of events 1 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
0.00%
0/25 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
|
Investigations
Blood alkaline phosphatase increased
|
0.00%
0/7 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
0.00%
0/7 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
10.0%
1/10 • Number of events 1 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
0.00%
0/7 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
16.0%
4/25 • Number of events 17 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
|
Investigations
Blood bilirubin increased
|
0.00%
0/7 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
0.00%
0/7 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
0.00%
0/10 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
0.00%
0/7 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
16.0%
4/25 • Number of events 4 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
|
Investigations
Lymphocyte count decreased
|
0.00%
0/7 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
0.00%
0/7 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
10.0%
1/10 • Number of events 1 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
0.00%
0/7 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
12.0%
3/25 • Number of events 23 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
|
Investigations
Gamma-glutamyltransferase increased
|
0.00%
0/7 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
0.00%
0/7 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
0.00%
0/10 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
0.00%
0/7 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
8.0%
2/25 • Number of events 2 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
|
Investigations
Alanine aminotransferase
|
0.00%
0/7 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
0.00%
0/7 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
0.00%
0/10 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
0.00%
0/7 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
4.0%
1/25 • Number of events 1 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
|
Investigations
Blood creatinine increased
|
0.00%
0/7 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
0.00%
0/7 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
0.00%
0/10 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
0.00%
0/7 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
4.0%
1/25 • Number of events 4 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
|
Investigations
Blood magnesium decreased
|
0.00%
0/7 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
0.00%
0/7 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
0.00%
0/10 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
0.00%
0/7 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
4.0%
1/25 • Number of events 1 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
|
Investigations
Cardiac murmur
|
14.3%
1/7 • Number of events 1 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
0.00%
0/7 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
0.00%
0/10 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
0.00%
0/7 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
0.00%
0/25 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
|
Investigations
Liver function test increased
|
0.00%
0/7 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
0.00%
0/7 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
0.00%
0/10 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
14.3%
1/7 • Number of events 1 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
0.00%
0/25 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
|
Investigations
Lung diffusion test decreased
|
0.00%
0/7 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
0.00%
0/7 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
0.00%
0/10 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
0.00%
0/7 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
4.0%
1/25 • Number of events 1 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
|
Investigations
Urine output decreased
|
14.3%
1/7 • Number of events 1 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
0.00%
0/7 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
0.00%
0/10 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
0.00%
0/7 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
0.00%
0/25 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
28.6%
2/7 • Number of events 2 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
0.00%
0/7 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
20.0%
2/10 • Number of events 3 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
28.6%
2/7 • Number of events 2 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
8.0%
2/25 • Number of events 2 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
14.3%
1/7 • Number of events 1 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
0.00%
0/7 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
20.0%
2/10 • Number of events 6 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
0.00%
0/7 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
8.0%
2/25 • Number of events 2 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/7 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
0.00%
0/7 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
10.0%
1/10 • Number of events 1 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
28.6%
2/7 • Number of events 3 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
8.0%
2/25 • Number of events 2 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/7 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
0.00%
0/7 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
10.0%
1/10 • Number of events 1 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
0.00%
0/7 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
12.0%
3/25 • Number of events 3 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
0.00%
0/7 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
0.00%
0/7 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
0.00%
0/10 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
0.00%
0/7 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
8.0%
2/25 • Number of events 2 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/7 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
14.3%
1/7 • Number of events 1 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
10.0%
1/10 • Number of events 1 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
0.00%
0/7 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
0.00%
0/25 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/7 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
28.6%
2/7 • Number of events 3 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
0.00%
0/10 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
0.00%
0/7 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
0.00%
0/25 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Sinus congestion
|
0.00%
0/7 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
0.00%
0/7 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
10.0%
1/10 • Number of events 1 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
0.00%
0/7 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
4.0%
1/25 • Number of events 1 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Catarrh
|
0.00%
0/7 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
0.00%
0/7 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
0.00%
0/10 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
0.00%
0/7 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
4.0%
1/25 • Number of events 1 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
14.3%
1/7 • Number of events 1 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
0.00%
0/7 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
0.00%
0/10 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
0.00%
0/7 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
0.00%
0/25 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
0.00%
0/7 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
0.00%
0/7 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
10.0%
1/10 • Number of events 1 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
0.00%
0/7 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
0.00%
0/25 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
0.00%
0/7 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
0.00%
0/7 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
0.00%
0/10 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
14.3%
1/7 • Number of events 1 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
0.00%
0/25 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/7 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
0.00%
0/7 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
0.00%
0/10 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
14.3%
1/7 • Number of events 2 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
0.00%
0/25 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Laryngeal oedema
|
0.00%
0/7 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
0.00%
0/7 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
0.00%
0/10 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
0.00%
0/7 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
4.0%
1/25 • Number of events 6 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal dryness
|
0.00%
0/7 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
14.3%
1/7 • Number of events 1 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
0.00%
0/10 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
0.00%
0/7 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
0.00%
0/25 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngeal inflammation
|
0.00%
0/7 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
0.00%
0/7 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
0.00%
0/10 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
0.00%
0/7 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
4.0%
1/25 • Number of events 1 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.00%
0/7 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
0.00%
0/7 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
10.0%
1/10 • Number of events 1 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
0.00%
0/7 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
0.00%
0/25 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
14.3%
1/7 • Number of events 1 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
0.00%
0/7 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
0.00%
0/10 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
0.00%
0/7 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
0.00%
0/25 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Upper-airway cough syndrome
|
0.00%
0/7 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
14.3%
1/7 • Number of events 1 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
0.00%
0/10 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
0.00%
0/7 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
0.00%
0/25 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
|
Psychiatric disorders
Depression
|
14.3%
1/7 • Number of events 1 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
71.4%
5/7 • Number of events 6 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
10.0%
1/10 • Number of events 1 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
14.3%
1/7 • Number of events 1 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
8.0%
2/25 • Number of events 2 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
|
Psychiatric disorders
Insomnia
|
14.3%
1/7 • Number of events 1 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
0.00%
0/7 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
10.0%
1/10 • Number of events 1 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
28.6%
2/7 • Number of events 2 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
20.0%
5/25 • Number of events 6 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
|
Psychiatric disorders
Anxiety
|
14.3%
1/7 • Number of events 1 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
0.00%
0/7 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
10.0%
1/10 • Number of events 1 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
28.6%
2/7 • Number of events 2 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
12.0%
3/25 • Number of events 3 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
|
Psychiatric disorders
Confusional state
|
14.3%
1/7 • Number of events 1 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
0.00%
0/7 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
0.00%
0/10 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
0.00%
0/7 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
4.0%
1/25 • Number of events 1 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
|
Psychiatric disorders
Hallucination
|
14.3%
1/7 • Number of events 1 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
0.00%
0/7 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
0.00%
0/10 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
0.00%
0/7 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
0.00%
0/25 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
|
Psychiatric disorders
Irritability
|
0.00%
0/7 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
0.00%
0/7 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
0.00%
0/10 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
0.00%
0/7 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
4.0%
1/25 • Number of events 1 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
|
Infections and infestations
Oral candidiasis
|
14.3%
1/7 • Number of events 1 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
14.3%
1/7 • Number of events 2 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
10.0%
1/10 • Number of events 1 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
14.3%
1/7 • Number of events 1 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
8.0%
2/25 • Number of events 2 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
|
Infections and infestations
Pneumonia
|
14.3%
1/7 • Number of events 1 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
0.00%
0/7 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
20.0%
2/10 • Number of events 2 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
0.00%
0/7 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
4.0%
1/25 • Number of events 1 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/7 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
0.00%
0/7 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
10.0%
1/10 • Number of events 1 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
0.00%
0/7 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
4.0%
1/25 • Number of events 1 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
|
Infections and infestations
Bacterial sepsis
|
0.00%
0/7 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
0.00%
0/7 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
0.00%
0/10 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
0.00%
0/7 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
4.0%
1/25 • Number of events 1 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
|
Infections and infestations
Candida infection
|
0.00%
0/7 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
0.00%
0/7 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
0.00%
0/10 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
0.00%
0/7 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
4.0%
1/25 • Number of events 1 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
|
Infections and infestations
Clostridium difficile colitis
|
14.3%
1/7 • Number of events 1 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
0.00%
0/7 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
0.00%
0/10 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
0.00%
0/7 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
0.00%
0/25 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
|
Infections and infestations
Fungal infection
|
0.00%
0/7 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
0.00%
0/7 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
10.0%
1/10 • Number of events 1 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
0.00%
0/7 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
0.00%
0/25 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
|
Infections and infestations
Gingivitis
|
0.00%
0/7 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
14.3%
1/7 • Number of events 1 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
0.00%
0/10 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
0.00%
0/7 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
0.00%
0/25 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
|
Infections and infestations
Helicobacter infection
|
0.00%
0/7 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
0.00%
0/7 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
0.00%
0/10 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
0.00%
0/7 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
4.0%
1/25 • Number of events 1 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
|
Infections and infestations
Herpes zoster
|
0.00%
0/7 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
0.00%
0/7 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
10.0%
1/10 • Number of events 1 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
0.00%
0/7 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
0.00%
0/25 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
|
Infections and infestations
Neutropenic infection
|
14.3%
1/7 • Number of events 2 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
0.00%
0/7 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
0.00%
0/10 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
0.00%
0/7 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
0.00%
0/25 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
|
Infections and infestations
Neutropenic sepsis
|
14.3%
1/7 • Number of events 1 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
0.00%
0/7 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
0.00%
0/10 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
0.00%
0/7 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
0.00%
0/25 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
|
Infections and infestations
Paronychia
|
0.00%
0/7 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
0.00%
0/7 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
0.00%
0/10 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
0.00%
0/7 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
4.0%
1/25 • Number of events 1 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
|
Infections and infestations
Pharyngitis
|
0.00%
0/7 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
0.00%
0/7 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
0.00%
0/10 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
0.00%
0/7 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
4.0%
1/25 • Number of events 1 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
|
Infections and infestations
Sepsis
|
0.00%
0/7 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
0.00%
0/7 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
0.00%
0/10 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
0.00%
0/7 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
4.0%
1/25 • Number of events 2 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
|
Infections and infestations
Septic shock
|
14.3%
1/7 • Number of events 1 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
0.00%
0/7 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
0.00%
0/10 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
0.00%
0/7 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
0.00%
0/25 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
|
Infections and infestations
Tooth infection
|
14.3%
1/7 • Number of events 1 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
0.00%
0/7 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
0.00%
0/10 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
0.00%
0/7 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
0.00%
0/25 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/7 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
0.00%
0/7 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
0.00%
0/10 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
0.00%
0/7 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
4.0%
1/25 • Number of events 1 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/7 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
0.00%
0/7 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
0.00%
0/10 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
0.00%
0/7 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
4.0%
1/25 • Number of events 2 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
|
Infections and infestations
Vulvovaginitis trichomonal
|
0.00%
0/7 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
0.00%
0/7 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
0.00%
0/10 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
0.00%
0/7 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
4.0%
1/25 • Number of events 1 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
14.3%
1/7 • Number of events 1 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
14.3%
1/7 • Number of events 2 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
10.0%
1/10 • Number of events 1 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
0.00%
0/7 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
8.0%
2/25 • Number of events 6 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/7 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
0.00%
0/7 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
0.00%
0/10 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
0.00%
0/7 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
12.0%
3/25 • Number of events 3 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
14.3%
1/7 • Number of events 1 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
0.00%
0/7 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
0.00%
0/10 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
14.3%
1/7 • Number of events 1 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
4.0%
1/25 • Number of events 1 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/7 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
0.00%
0/7 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
0.00%
0/10 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
0.00%
0/7 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
12.0%
3/25 • Number of events 3 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.00%
0/7 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
0.00%
0/7 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
0.00%
0/10 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
14.3%
1/7 • Number of events 1 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
4.0%
1/25 • Number of events 1 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
0.00%
0/7 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
0.00%
0/7 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
0.00%
0/10 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
0.00%
0/7 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
4.0%
1/25 • Number of events 1 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
|
Musculoskeletal and connective tissue disorders
Joint stiffness
|
0.00%
0/7 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
14.3%
1/7 • Number of events 1 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
0.00%
0/10 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
0.00%
0/7 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
0.00%
0/25 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.00%
0/7 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
0.00%
0/7 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
0.00%
0/10 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
0.00%
0/7 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
4.0%
1/25 • Number of events 1 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.00%
0/7 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
14.3%
1/7 • Number of events 1 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
0.00%
0/10 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
0.00%
0/7 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
0.00%
0/25 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/7 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
0.00%
0/7 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
0.00%
0/10 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
0.00%
0/7 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
4.0%
1/25 • Number of events 1 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/7 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
0.00%
0/7 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
0.00%
0/10 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
0.00%
0/7 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
4.0%
1/25 • Number of events 1 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
|
Musculoskeletal and connective tissue disorders
Periarthritis
|
0.00%
0/7 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
0.00%
0/7 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
0.00%
0/10 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
0.00%
0/7 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
4.0%
1/25 • Number of events 1 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
14.3%
1/7 • Number of events 1 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
42.9%
3/7 • Number of events 3 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
0.00%
0/10 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
14.3%
1/7 • Number of events 1 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
16.0%
4/25 • Number of events 5 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
0.00%
0/7 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
14.3%
1/7 • Number of events 1 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
10.0%
1/10 • Number of events 1 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
0.00%
0/7 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
4.0%
1/25 • Number of events 1 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/7 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
0.00%
0/7 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
10.0%
1/10 • Number of events 1 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
0.00%
0/7 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
8.0%
2/25 • Number of events 2 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/7 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
0.00%
0/7 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
10.0%
1/10 • Number of events 1 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
0.00%
0/7 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
4.0%
1/25 • Number of events 2 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
|
Skin and subcutaneous tissue disorders
Decubitus ulcer
|
0.00%
0/7 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
0.00%
0/7 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
0.00%
0/10 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
14.3%
1/7 • Number of events 1 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
0.00%
0/25 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
|
Skin and subcutaneous tissue disorders
Ingrowing nail
|
0.00%
0/7 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
0.00%
0/7 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
0.00%
0/10 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
0.00%
0/7 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
4.0%
1/25 • Number of events 1 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
|
Skin and subcutaneous tissue disorders
Nail discolouration
|
14.3%
1/7 • Number of events 1 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
0.00%
0/7 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
0.00%
0/10 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
0.00%
0/7 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
0.00%
0/25 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
|
Skin and subcutaneous tissue disorders
Nail ridging
|
0.00%
0/7 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
0.00%
0/7 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
10.0%
1/10 • Number of events 1 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
0.00%
0/7 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
0.00%
0/25 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
|
Skin and subcutaneous tissue disorders
Pain of skin
|
14.3%
1/7 • Number of events 1 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
0.00%
0/7 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
0.00%
0/10 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
0.00%
0/7 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
0.00%
0/25 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
|
Skin and subcutaneous tissue disorders
Palmar-plantar erythrodysaesthesia syndrome
|
0.00%
0/7 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
0.00%
0/7 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
0.00%
0/10 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
0.00%
0/7 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
4.0%
1/25 • Number of events 1 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
|
Skin and subcutaneous tissue disorders
Petechiae
|
14.3%
1/7 • Number of events 1 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
0.00%
0/7 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
0.00%
0/10 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
0.00%
0/7 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
0.00%
0/25 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
|
Skin and subcutaneous tissue disorders
Prurigo
|
0.00%
0/7 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
0.00%
0/7 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
0.00%
0/10 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
0.00%
0/7 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
4.0%
1/25 • Number of events 1 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
|
Vascular disorders
Hypertension
|
28.6%
2/7 • Number of events 5 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
57.1%
4/7 • Number of events 8 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
0.00%
0/10 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
0.00%
0/7 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
0.00%
0/25 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
|
Vascular disorders
Deep vein thrombosis
|
0.00%
0/7 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
14.3%
1/7 • Number of events 1 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
0.00%
0/10 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
0.00%
0/7 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
12.0%
3/25 • Number of events 3 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
|
Vascular disorders
Orthostatic hypotension
|
28.6%
2/7 • Number of events 3 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
0.00%
0/7 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
0.00%
0/10 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
0.00%
0/7 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
0.00%
0/25 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
|
Vascular disorders
Embolism
|
0.00%
0/7 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
0.00%
0/7 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
10.0%
1/10 • Number of events 1 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
0.00%
0/7 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
0.00%
0/25 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
|
Vascular disorders
Vascular occlusion
|
0.00%
0/7 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
0.00%
0/7 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
0.00%
0/10 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
0.00%
0/7 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
4.0%
1/25 • Number of events 1 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
|
Injury, poisoning and procedural complications
Fall
|
14.3%
1/7 • Number of events 4 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
14.3%
1/7 • Number of events 1 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
10.0%
1/10 • Number of events 1 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
0.00%
0/7 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
0.00%
0/25 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/7 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
0.00%
0/7 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
10.0%
1/10 • Number of events 1 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
0.00%
0/7 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
4.0%
1/25 • Number of events 1 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
|
Injury, poisoning and procedural complications
Tooth fracture
|
0.00%
0/7 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
14.3%
1/7 • Number of events 1 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
0.00%
0/10 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
14.3%
1/7 • Number of events 1 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
0.00%
0/25 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
|
Injury, poisoning and procedural complications
Animal scratch
|
0.00%
0/7 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
0.00%
0/7 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
0.00%
0/10 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
0.00%
0/7 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
4.0%
1/25 • Number of events 1 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
|
Injury, poisoning and procedural complications
Ligament sprain
|
14.3%
1/7 • Number of events 1 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
0.00%
0/7 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
0.00%
0/10 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
0.00%
0/7 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
0.00%
0/25 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
|
Injury, poisoning and procedural complications
Skin abrasion
|
14.3%
1/7 • Number of events 1 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
0.00%
0/7 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
0.00%
0/10 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
0.00%
0/7 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
0.00%
0/25 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
|
Injury, poisoning and procedural complications
Subdural haematoma
|
0.00%
0/7 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
0.00%
0/7 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
10.0%
1/10 • Number of events 1 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
0.00%
0/7 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
0.00%
0/25 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/7 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
0.00%
0/7 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
0.00%
0/10 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
28.6%
2/7 • Number of events 2 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
0.00%
0/25 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
|
Renal and urinary disorders
Micturition urgency
|
14.3%
1/7 • Number of events 1 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
0.00%
0/7 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
0.00%
0/10 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
0.00%
0/7 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
4.0%
1/25 • Number of events 1 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
|
Renal and urinary disorders
Haematuria
|
0.00%
0/7 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
0.00%
0/7 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
0.00%
0/10 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
0.00%
0/7 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
4.0%
1/25 • Number of events 1 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.00%
0/7 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
0.00%
0/7 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
0.00%
0/10 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
0.00%
0/7 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
4.0%
1/25 • Number of events 1 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
|
Renal and urinary disorders
Oliguria
|
14.3%
1/7 • Number of events 1 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
0.00%
0/7 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
0.00%
0/10 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
0.00%
0/7 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
0.00%
0/25 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
|
Renal and urinary disorders
Pollakiuria
|
14.3%
1/7 • Number of events 1 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
0.00%
0/7 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
0.00%
0/10 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
0.00%
0/7 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
0.00%
0/25 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
|
Renal and urinary disorders
Ureterolithiasis
|
0.00%
0/7 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
0.00%
0/7 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
0.00%
0/10 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
0.00%
0/7 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
4.0%
1/25 • Number of events 1 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
|
Renal and urinary disorders
Urinary incontinence
|
14.3%
1/7 • Number of events 1 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
0.00%
0/7 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
0.00%
0/10 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
0.00%
0/7 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
0.00%
0/25 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
|
Renal and urinary disorders
Urinary retention
|
0.00%
0/7 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
0.00%
0/7 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
0.00%
0/10 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
14.3%
1/7 • Number of events 1 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
0.00%
0/25 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
|
Hepatobiliary disorders
Bile duct obstruction
|
0.00%
0/7 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
0.00%
0/7 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
0.00%
0/10 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
0.00%
0/7 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
4.0%
1/25 • Number of events 1 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
|
Hepatobiliary disorders
Biliary dilatation
|
0.00%
0/7 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
0.00%
0/7 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
0.00%
0/10 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
0.00%
0/7 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
4.0%
1/25 • Number of events 1 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
|
Hepatobiliary disorders
Cholangitis
|
0.00%
0/7 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
0.00%
0/7 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
0.00%
0/10 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
0.00%
0/7 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
4.0%
1/25 • Number of events 1 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
|
Hepatobiliary disorders
Cholecystitis
|
0.00%
0/7 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
14.3%
1/7 • Number of events 1 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
0.00%
0/10 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
0.00%
0/7 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
0.00%
0/25 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
|
Hepatobiliary disorders
Hepatotoxicity
|
0.00%
0/7 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
0.00%
0/7 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
0.00%
0/10 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
0.00%
0/7 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
4.0%
1/25 • Number of events 1 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
|
Hepatobiliary disorders
Portal vein thrombosis
|
0.00%
0/7 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
14.3%
1/7 • Number of events 1 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
0.00%
0/10 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
0.00%
0/7 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
0.00%
0/25 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
|
Cardiac disorders
Tachycardia
|
14.3%
1/7 • Number of events 1 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
0.00%
0/7 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
0.00%
0/10 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
0.00%
0/7 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
4.0%
1/25 • Number of events 1 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
|
Cardiac disorders
Arteriospasm coronary
|
0.00%
0/7 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
0.00%
0/7 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
10.0%
1/10 • Number of events 1 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
0.00%
0/7 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
0.00%
0/25 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
|
Cardiac disorders
Palpitations
|
14.3%
1/7 • Number of events 1 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
0.00%
0/7 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
0.00%
0/10 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
0.00%
0/7 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
0.00%
0/25 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
|
Cardiac disorders
Sinus tachycardia
|
14.3%
1/7 • Number of events 1 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
0.00%
0/7 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
0.00%
0/10 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
0.00%
0/7 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
0.00%
0/25 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
|
Eye disorders
Eye disorder
|
0.00%
0/7 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
0.00%
0/7 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
0.00%
0/10 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
0.00%
0/7 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
4.0%
1/25 • Number of events 1 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
|
Eye disorders
Eyelid oedema
|
0.00%
0/7 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
0.00%
0/7 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
0.00%
0/10 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
0.00%
0/7 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
4.0%
1/25 • Number of events 1 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
|
Eye disorders
Vision blurred
|
0.00%
0/7 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
14.3%
1/7 • Number of events 1 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
0.00%
0/10 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
0.00%
0/7 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
0.00%
0/25 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
|
Endocrine disorders
Hypothyroidism
|
14.3%
1/7 • Number of events 1 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
0.00%
0/7 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
0.00%
0/10 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
0.00%
0/7 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
0.00%
0/25 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
|
Immune system disorders
Drug hypersensitivity
|
0.00%
0/7 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
0.00%
0/7 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
0.00%
0/10 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
0.00%
0/7 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
4.0%
1/25 • Number of events 1 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
|
Reproductive system and breast disorders
Vulvovaginal swelling
|
0.00%
0/7 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
0.00%
0/7 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
0.00%
0/10 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
0.00%
0/7 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
4.0%
1/25 • Number of events 1 • Treatment-emergent adverse events are reported from the time of first study treatment administration (Day 1) up to 30 days after the date of last study treatment administration or until the start of alternative anticancer therapy, approximately 1008 days. All-Cause Mortality are reported from first participant enrolled to last participant died, approximately 1946 days.
Safety population included participants who received at least 1 dose of any study treatment.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place