Trial Outcomes & Findings for Study to Assess Safety, Tolerability and Clinical Activity of BGB-290 in Combination With Temozolomide (TMZ) in Participants With Locally Advanced or Metastatic Solid Tumors (NCT NCT03150810)

NCT ID: NCT03150810

Last Updated: 2024-12-20

Results Overview

A DLT is defined as one of the following toxicities occurring during the DLT assessment window: Grade ≥3 non-hematologic, non-hepatic major organ adverse event (AE) Grade 4 neutropenia lasting \>7 days Grade ≥3 febrile neutropenia Grade 3 thrombocytopenia with clinically significant bleeding Grade 4 thrombocytopenia lasting \> 3 days and requiring transfusion, or any decreased platelet count \<15,000/mm3/ \<15.0 x 109/L Grade ≥4 anemia Grade ≥3 total bilirubin or hepatic transaminases (ALT or AST)

Recruitment status

COMPLETED

Study phase

PHASE1

Target enrollment

139 participants

Primary outcome timeframe

From first dose of study drug(s) to 28 days post-dose (up to approximately 1 year and 6 months)

Results posted on

2024-12-20

Participant Flow

Participants were enrolled in multiple study centers in Australia, Europe, and North America.

Participant milestones

Participant milestones
Measure
Dose Escalation: Pamiparib + Temozolomide (TMZ) 40 mg (Days 1-7)
Pamiparib 60 mg twice daily on Days 1 to 28 in combination with pulse dosing of TMZ 40 mg once daily on Days 1 to 7 within a 28-day cycle
Dose Escalation: Pamiparib + TMZ 60 mg (Days 1-7)
Pamiparib 60 mg twice daily on Days 1 to 28 in combination with pulse dosing of TMZ 60 mg once daily on Days 1 to 7 within a 28-day cycle
Dose Escalation: Pamiparib + TMZ 80 mg (Days 1-7)
Pamiparib 60 mg twice daily on Days 1 to 28 in combination with pulse dosing of TMZ 80 mg once daily on Days 1 to 7 within a 28-day cycle
Dose Escalation: Pamiparib + TMZ 100 mg (Days 1-7)
Pamiparib 60 mg twice daily on Days 1 to 28 in combination with pulse dosing of TMZ 100 mg once daily on Days 1 to 7 within a 28-day cycle
Dose Escalation: Pamiparib + TMZ 120 mg (Days 1-7)
Pamiparib 60 mg twice daily on Days 1 to 28 in combination with pulse dosing of TMZ 120 mg once daily on Days 1 to 7 within a 28-day cycle
Dose Escalation: Pamiparib + TMZ 40 mg (Days 1-14)
Pamiparib 60 mg twice daily on Days 1 to 28 in combination with pulse dosing of TMZ 40 mg once daily on Days 1 to 14 within a 28-day cycle
Dose Escalation: Pamiparib + TMZ 20 mg (Days 1-28)
Pamiparib 60 mg twice daily in combination with TMZ 20 mg once daily administered continuously on Days 1 to 28 within a 28-day cycle
Dose Escalation: Pamiparib + TMZ 40 mg (Days 1-28)
Pamiparib 60 mg twice daily in combination with TMZ 40 mg once daily administered continuously on Days 1 to 28 within a 28-day cycle
Dose Expansion: Gastric Cancer
Participants with gastric or gastroesophageal junction cancer received TMZ 60 mg administered on Days 1 to 7 in combination with pamiparib 60 mg twice daily on Days 1 to 28 of each cycle
Dose Expansion: Ovarian Cancer
Participants with ovarian cancer, fallopian cancer, or primary peritoneal cancer received TMZ 60 mg administered on Days 1 to 7 in combination with pamiparib 60 mg twice daily on Days 1 to 28 of each cycle
Dose Expansion: SCLC
Participants with Small Cell Lung Cancer (SCLC) received TMZ 60 mg administered on Days 1 to 7 in combination with pamiparib 60 mg twice daily on Days 1 to 28 of each cycle
Dose Expansion: TNBC
Participants with triple negative breast cancer (TNBC) received TMZ 60 mg administered on Days 1 to 7 in combination with pamiparib 60 mg twice daily on Days 1 to 28 of each cycle
Dose Expansion: Other HRD+ Cancers
Participants with non-small cell lung cancer (NSCLC), esophageal cancer, squamous head and neck cancer, or soft tissue sarcomas whose tumors are homologous recombination deficiency (HRD)+ received TMZ 60 mg administered on Days 1 to 7 in combination with pamiparib 60 mg twice daily on Days 1 to 28 of each cycle
Overall Study
STARTED
4
13
9
3
3
14
14
6
21
4
22
1
25
Overall Study
COMPLETED
0
0
0
0
0
0
0
0
0
0
0
0
0
Overall Study
NOT COMPLETED
4
13
9
3
3
14
14
6
21
4
22
1
25

Reasons for withdrawal

Reasons for withdrawal
Measure
Dose Escalation: Pamiparib + Temozolomide (TMZ) 40 mg (Days 1-7)
Pamiparib 60 mg twice daily on Days 1 to 28 in combination with pulse dosing of TMZ 40 mg once daily on Days 1 to 7 within a 28-day cycle
Dose Escalation: Pamiparib + TMZ 60 mg (Days 1-7)
Pamiparib 60 mg twice daily on Days 1 to 28 in combination with pulse dosing of TMZ 60 mg once daily on Days 1 to 7 within a 28-day cycle
Dose Escalation: Pamiparib + TMZ 80 mg (Days 1-7)
Pamiparib 60 mg twice daily on Days 1 to 28 in combination with pulse dosing of TMZ 80 mg once daily on Days 1 to 7 within a 28-day cycle
Dose Escalation: Pamiparib + TMZ 100 mg (Days 1-7)
Pamiparib 60 mg twice daily on Days 1 to 28 in combination with pulse dosing of TMZ 100 mg once daily on Days 1 to 7 within a 28-day cycle
Dose Escalation: Pamiparib + TMZ 120 mg (Days 1-7)
Pamiparib 60 mg twice daily on Days 1 to 28 in combination with pulse dosing of TMZ 120 mg once daily on Days 1 to 7 within a 28-day cycle
Dose Escalation: Pamiparib + TMZ 40 mg (Days 1-14)
Pamiparib 60 mg twice daily on Days 1 to 28 in combination with pulse dosing of TMZ 40 mg once daily on Days 1 to 14 within a 28-day cycle
Dose Escalation: Pamiparib + TMZ 20 mg (Days 1-28)
Pamiparib 60 mg twice daily in combination with TMZ 20 mg once daily administered continuously on Days 1 to 28 within a 28-day cycle
Dose Escalation: Pamiparib + TMZ 40 mg (Days 1-28)
Pamiparib 60 mg twice daily in combination with TMZ 40 mg once daily administered continuously on Days 1 to 28 within a 28-day cycle
Dose Expansion: Gastric Cancer
Participants with gastric or gastroesophageal junction cancer received TMZ 60 mg administered on Days 1 to 7 in combination with pamiparib 60 mg twice daily on Days 1 to 28 of each cycle
Dose Expansion: Ovarian Cancer
Participants with ovarian cancer, fallopian cancer, or primary peritoneal cancer received TMZ 60 mg administered on Days 1 to 7 in combination with pamiparib 60 mg twice daily on Days 1 to 28 of each cycle
Dose Expansion: SCLC
Participants with Small Cell Lung Cancer (SCLC) received TMZ 60 mg administered on Days 1 to 7 in combination with pamiparib 60 mg twice daily on Days 1 to 28 of each cycle
Dose Expansion: TNBC
Participants with triple negative breast cancer (TNBC) received TMZ 60 mg administered on Days 1 to 7 in combination with pamiparib 60 mg twice daily on Days 1 to 28 of each cycle
Dose Expansion: Other HRD+ Cancers
Participants with non-small cell lung cancer (NSCLC), esophageal cancer, squamous head and neck cancer, or soft tissue sarcomas whose tumors are homologous recombination deficiency (HRD)+ received TMZ 60 mg administered on Days 1 to 7 in combination with pamiparib 60 mg twice daily on Days 1 to 28 of each cycle
Overall Study
Death
4
8
7
2
2
10
8
6
18
3
19
1
19
Overall Study
Withdrawal by Subject
0
1
1
1
0
0
2
0
2
0
1
0
1
Overall Study
Sponsor Decision
0
2
0
0
1
1
0
0
1
0
0
0
5
Overall Study
Lost to Follow-up
0
1
1
0
0
0
1
0
0
0
1
0
0
Overall Study
Physician Decision
0
0
0
0
0
1
1
0
0
0
0
0
0
Overall Study
Site withdrawal from study
0
1
0
0
0
0
0
0
0
1
1
0
0
Overall Study
Hospice
0
0
0
0
0
1
0
0
0
0
0
0
0
Overall Study
Participant relocated abroad.
0
0
0
0
0
1
0
0
0
0
0
0
0
Overall Study
Transferred care to oncologist
0
0
0
0
0
0
2
0
0
0
0
0
0

Baseline Characteristics

Study to Assess Safety, Tolerability and Clinical Activity of BGB-290 in Combination With Temozolomide (TMZ) in Participants With Locally Advanced or Metastatic Solid Tumors

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Dose Escalation: Pamiparib + Temozolomide (TMZ) 40 mg (Days 1-7)
n=4 Participants
Pamiparib 60 mg twice daily on Days 1 to 28 in combination with pulse dosing of TMZ 40 mg once daily on Days 1 to 7 within a 28-day cycle
Dose Escalation: Pamiparib + TMZ 60 mg (Days 1-7)
n=13 Participants
Pamiparib 60 mg twice daily on Days 1 to 28 in combination with pulse dosing of TMZ 60 mg once daily on Days 1 to 7 within a 28-day cycle
Dose Escalation: Pamiparib + TMZ 80 mg (Days 1-7)
n=9 Participants
Pamiparib 60 mg twice daily on Days 1 to 28 in combination with pulse dosing of TMZ 80 mg once daily on Days 1 to 7 within a 28-day cycle
Dose Escalation: Pamiparib + TMZ 100 mg (Days 1-7)
n=3 Participants
Pamiparib 60 mg twice daily on Days 1 to 28 in combination with pulse dosing of TMZ 100 mg once daily on Days 1 to 7 within a 28-day cycle
Dose Escalation: Pamiparib + TMZ 120 mg (Days 1-7)
n=3 Participants
Pamiparib 60 mg twice daily on Days 1 to 28 in combination with pulse dosing of TMZ 120 mg once daily on Days 1 to 7 within a 28-day cycle
Dose Escalation: Pamiparib + TMZ 40 mg (Days 1-14)
n=14 Participants
Pamiparib 60 mg twice daily on Days 1 to 28 in combination with pulse dosing of TMZ 40 mg once daily on Days 1 to 14 within a 28-day cycle
Dose Escalation: Pamiparib + TMZ 20 mg (Days 1-28)
n=14 Participants
Pamiparib 60 mg twice daily in combination with TMZ 20 mg once daily administered continuously on Days 1 to 28 within a 28-day cycle
Dose Escalation: Pamiparib + TMZ 40 mg (Days 1-28)
n=6 Participants
Pamiparib 60 mg twice daily in combination with TMZ 40 mg once daily administered continuously on Days 1 to 28 within a 28-day cycle
Dose Expansion: Gastric Cancer
n=21 Participants
Participants with gastric or gastroesophageal junction cancer received TMZ 60 mg once daily administered on Days 1 to 7 in combination with pamiparib 60 mg twice daily on Days 1 to 28 of each cycle
Dose Expansion: Ovarian Cancer
n=4 Participants
Participants with ovarian cancer, fallopian cancer, or primary peritoneal cancer received TMZ 60 mg once daily administered on Days 1 to 7 in combination with pamiparib 60 mg twice daily on Days 1 to 28 of each cycle
Dose Expansion: SCLC
n=22 Participants
Participants with Small Cell Lung Cancer (SCLC) received TMZ 60 mg once daily administered on Days 1 to 7 in combination with pamiparib 60 mg twice daily on Days 1 to 28 of each cycle
Dose Expansion: TNBC
n=1 Participants
Participants with triple negative breast cancer (TNBC) received TMZ 60 mg once daily administered on Days 1 to 7 in combination with pamiparib 60 mg twice daily on Days 1 to 28 of each cycle
Dose Expansion: Other HRD+ Cancers
n=25 Participants
Participants with non-small cell lung cancer (NSCLC), esophageal cancer, squamous head and neck cancer, or soft tissue sarcomas whose tumors are homologous recombination deficiency (HRD)+ received TMZ 60 mg once daily administered on Days 1 to 7 in combination with pamiparib 60 mg twice daily on Days 1 to 28 of each cycle
Total
n=139 Participants
Total of all reporting groups
Age, Continuous
63.5 years
STANDARD_DEVIATION 6.19 • n=5 Participants
58.0 years
STANDARD_DEVIATION 10.52 • n=7 Participants
72.3 years
STANDARD_DEVIATION 6.22 • n=5 Participants
60.3 years
STANDARD_DEVIATION 10.69 • n=4 Participants
65.7 years
STANDARD_DEVIATION 13.80 • n=21 Participants
66.7 years
STANDARD_DEVIATION 10.21 • n=8 Participants
66.9 years
STANDARD_DEVIATION 9.96 • n=8 Participants
66.7 years
STANDARD_DEVIATION 8.31 • n=24 Participants
58.8 years
STANDARD_DEVIATION 14.68 • n=42 Participants
59.3 years
STANDARD_DEVIATION 2.22 • n=42 Participants
61.9 years
STANDARD_DEVIATION 8.33 • n=42 Participants
31.0 years
STANDARD_DEVIATION NA • n=42 Participants
58.1 years
STANDARD_DEVIATION 8.28 • n=36 Participants
62.0 years
STANDARD_DEVIATION 10.89 • n=36 Participants
Sex: Female, Male
Female
3 Participants
n=5 Participants
7 Participants
n=7 Participants
5 Participants
n=5 Participants
2 Participants
n=4 Participants
1 Participants
n=21 Participants
6 Participants
n=8 Participants
7 Participants
n=8 Participants
2 Participants
n=24 Participants
8 Participants
n=42 Participants
4 Participants
n=42 Participants
8 Participants
n=42 Participants
1 Participants
n=42 Participants
10 Participants
n=36 Participants
64 Participants
n=36 Participants
Sex: Female, Male
Male
1 Participants
n=5 Participants
6 Participants
n=7 Participants
4 Participants
n=5 Participants
1 Participants
n=4 Participants
2 Participants
n=21 Participants
8 Participants
n=8 Participants
7 Participants
n=8 Participants
4 Participants
n=24 Participants
13 Participants
n=42 Participants
0 Participants
n=42 Participants
14 Participants
n=42 Participants
0 Participants
n=42 Participants
15 Participants
n=36 Participants
75 Participants
n=36 Participants
Ethnicity (NIH/OMB)
Hispanic or Latino
0 Participants
n=5 Participants
1 Participants
n=7 Participants
2 Participants
n=5 Participants
0 Participants
n=4 Participants
0 Participants
n=21 Participants
1 Participants
n=8 Participants
5 Participants
n=8 Participants
1 Participants
n=24 Participants
1 Participants
n=42 Participants
1 Participants
n=42 Participants
0 Participants
n=42 Participants
0 Participants
n=42 Participants
0 Participants
n=36 Participants
12 Participants
n=36 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
4 Participants
n=5 Participants
11 Participants
n=7 Participants
7 Participants
n=5 Participants
2 Participants
n=4 Participants
3 Participants
n=21 Participants
11 Participants
n=8 Participants
8 Participants
n=8 Participants
4 Participants
n=24 Participants
18 Participants
n=42 Participants
3 Participants
n=42 Participants
18 Participants
n=42 Participants
1 Participants
n=42 Participants
20 Participants
n=36 Participants
110 Participants
n=36 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants
n=5 Participants
1 Participants
n=7 Participants
0 Participants
n=5 Participants
1 Participants
n=4 Participants
0 Participants
n=21 Participants
2 Participants
n=8 Participants
1 Participants
n=8 Participants
1 Participants
n=24 Participants
2 Participants
n=42 Participants
0 Participants
n=42 Participants
4 Participants
n=42 Participants
0 Participants
n=42 Participants
5 Participants
n=36 Participants
17 Participants
n=36 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
0 Participants
n=4 Participants
0 Participants
n=21 Participants
0 Participants
n=8 Participants
0 Participants
n=8 Participants
0 Participants
n=24 Participants
0 Participants
n=42 Participants
0 Participants
n=42 Participants
0 Participants
n=42 Participants
0 Participants
n=42 Participants
0 Participants
n=36 Participants
0 Participants
n=36 Participants
Race (NIH/OMB)
Asian
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
0 Participants
n=4 Participants
0 Participants
n=21 Participants
1 Participants
n=8 Participants
0 Participants
n=8 Participants
0 Participants
n=24 Participants
0 Participants
n=42 Participants
1 Participants
n=42 Participants
0 Participants
n=42 Participants
0 Participants
n=42 Participants
0 Participants
n=36 Participants
2 Participants
n=36 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
0 Participants
n=4 Participants
0 Participants
n=21 Participants
0 Participants
n=8 Participants
0 Participants
n=8 Participants
0 Participants
n=24 Participants
1 Participants
n=42 Participants
0 Participants
n=42 Participants
0 Participants
n=42 Participants
0 Participants
n=42 Participants
0 Participants
n=36 Participants
1 Participants
n=36 Participants
Race (NIH/OMB)
Black or African American
0 Participants
n=5 Participants
1 Participants
n=7 Participants
0 Participants
n=5 Participants
1 Participants
n=4 Participants
2 Participants
n=21 Participants
3 Participants
n=8 Participants
1 Participants
n=8 Participants
1 Participants
n=24 Participants
1 Participants
n=42 Participants
0 Participants
n=42 Participants
0 Participants
n=42 Participants
0 Participants
n=42 Participants
0 Participants
n=36 Participants
10 Participants
n=36 Participants
Race (NIH/OMB)
White
4 Participants
n=5 Participants
10 Participants
n=7 Participants
9 Participants
n=5 Participants
2 Participants
n=4 Participants
1 Participants
n=21 Participants
7 Participants
n=8 Participants
8 Participants
n=8 Participants
5 Participants
n=24 Participants
18 Participants
n=42 Participants
2 Participants
n=42 Participants
18 Participants
n=42 Participants
1 Participants
n=42 Participants
20 Participants
n=36 Participants
105 Participants
n=36 Participants
Race (NIH/OMB)
More than one race
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
0 Participants
n=4 Participants
0 Participants
n=21 Participants
0 Participants
n=8 Participants
0 Participants
n=8 Participants
0 Participants
n=24 Participants
0 Participants
n=42 Participants
0 Participants
n=42 Participants
0 Participants
n=42 Participants
0 Participants
n=42 Participants
0 Participants
n=36 Participants
0 Participants
n=36 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants
n=5 Participants
2 Participants
n=7 Participants
0 Participants
n=5 Participants
0 Participants
n=4 Participants
0 Participants
n=21 Participants
3 Participants
n=8 Participants
5 Participants
n=8 Participants
0 Participants
n=24 Participants
1 Participants
n=42 Participants
1 Participants
n=42 Participants
4 Participants
n=42 Participants
0 Participants
n=42 Participants
5 Participants
n=36 Participants
21 Participants
n=36 Participants

PRIMARY outcome

Timeframe: From first dose of study drug(s) to 28 days post-dose (up to approximately 1 year and 6 months)

Population: The dose-escalation safety analysis set comprised all dose-escalation phase participants who received pamiparib and/or TMZ.

A DLT is defined as one of the following toxicities occurring during the DLT assessment window: Grade ≥3 non-hematologic, non-hepatic major organ adverse event (AE) Grade 4 neutropenia lasting \>7 days Grade ≥3 febrile neutropenia Grade 3 thrombocytopenia with clinically significant bleeding Grade 4 thrombocytopenia lasting \> 3 days and requiring transfusion, or any decreased platelet count \<15,000/mm3/ \<15.0 x 109/L Grade ≥4 anemia Grade ≥3 total bilirubin or hepatic transaminases (ALT or AST)

Outcome measures

Outcome measures
Measure
Dose Escalation: Pamiparib + Temozolomide (TMZ) 40 mg (Days 1-7)
n=4 Participants
Pamiparib 60 mg twice daily on Days 1 to 28 in combination with pulse dosing of TMZ 40 mg once daily on Days 1 to 7 within a 28-day cycle
Dose Escalation: Pamiparib + TMZ 60 mg (Days 1-7)
n=13 Participants
Pamiparib 60 mg twice daily on Days 1 to 28 in combination with pulse dosing of TMZ 60 mg once daily on Days 1 to 7 within a 28-day cycle
Dose Escalation: Pamiparib + TMZ 80 mg (Days 1-7)
n=9 Participants
Pamiparib 60 mg twice daily on Days 1 to 28 in combination with pulse dosing of TMZ 80 mg once daily on Days 1 to 7 within a 28-day cycle
Dose Escalation: Pamiparib + TMZ 100 mg (Days 1-7)
n=3 Participants
Pamiparib 60 mg twice daily on Days 1 to 28 in combination with pulse dosing of TMZ 100 mg once daily on Days 1 to 7 within a 28-day cycle
Dose Escalation: Pamiparib + TMZ 120 mg (Days 1-7)
n=3 Participants
Pamiparib 60 mg twice daily on Days 1 to 28 in combination with pulse dosing of TMZ 120 mg once daily on Days 1 to 7 within a 28-day cycle
Dose Escalation: Pamiparib + TMZ 40 mg (Days 1-14)
n=14 Participants
Pamiparib 60 mg twice daily on Days 1 to 28 in combination with pulse dosing of TMZ 40 mg once daily on Days 1 to 14 within a 28-day cycle
Dose Escalation: Pamiparib + TMZ 20 mg (Days 1-28)
n=14 Participants
Pamiparib 60 mg twice daily in combination with TMZ 20 mg once daily administered continuously on Days 1 to 28 within a 28-day cycle
Dose Escalation: Pamiparib + TMZ 40 mg (Days 1-28)
n=6 Participants
Pamiparib 60 mg twice daily in combination with TMZ 40 mg once daily administered continuously on Days 1 to 28 within a 28-day cycle
Dose Expansion: Gastric Cancer
Participants with gastric or gastroesophageal junction cancer received TMZ 60 mg once daily administered on Days 1 to 7 in combination with pamiparib 60 mg twice daily on Days 1 to 28 of each cycle
Dose Expansion: Ovarian Cancer
Participants with ovarian cancer, fallopian cancer, or primary peritoneal cancer received TMZ 60 mg once daily administered on Days 1 to 7 in combination with pamiparib 60 mg twice daily on Days 1 to 28 of each cycle
Dose Expansion: SCLC
Participants with Small Cell Lung Cancer (SCLC) received TMZ 60 mg once daily administered on Days 1 to 7 in combination with pamiparib 60 mg twice daily on Days 1 to 28 of each cycle
Dose Expansion: TNBC
Participants with triple negative breast cancer (TNBC) received TMZ 60 mg once daily administered on Days 1 to 7 in combination with pamiparib 60 mg twice daily on Days 1 to 28 of each cycle
Dose Expansion: Other HRD+ Cancers
Participants with non-small cell lung cancer (NSCLC), esophageal cancer, squamous head and neck cancer, or soft tissue sarcomas whose tumors are homologous recombination deficiency (HRD)+ received TMZ 60 mg once daily administered on Days 1 to 7 in combination with pamiparib 60 mg twice daily on Days 1 to 28 of each cycle
Dose Escalation: Number of Participants With Dose Limiting Toxicities (DLTs)
0 Participants
0 Participants
0 Participants
2 Participants
2 Participants
0 Participants
0 Participants
0 Participants

PRIMARY outcome

Timeframe: From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months

Population: The Safety Analysis Set included all participants who received any dose of pamiparib and/or TMZ.

Number of participants with treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs), including laboratory values, vital signs, physical examination findings, and electrocardiogram results, graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), v4.03

Outcome measures

Outcome measures
Measure
Dose Escalation: Pamiparib + Temozolomide (TMZ) 40 mg (Days 1-7)
n=4 Participants
Pamiparib 60 mg twice daily on Days 1 to 28 in combination with pulse dosing of TMZ 40 mg once daily on Days 1 to 7 within a 28-day cycle
Dose Escalation: Pamiparib + TMZ 60 mg (Days 1-7)
n=13 Participants
Pamiparib 60 mg twice daily on Days 1 to 28 in combination with pulse dosing of TMZ 60 mg once daily on Days 1 to 7 within a 28-day cycle
Dose Escalation: Pamiparib + TMZ 80 mg (Days 1-7)
n=9 Participants
Pamiparib 60 mg twice daily on Days 1 to 28 in combination with pulse dosing of TMZ 80 mg once daily on Days 1 to 7 within a 28-day cycle
Dose Escalation: Pamiparib + TMZ 100 mg (Days 1-7)
n=3 Participants
Pamiparib 60 mg twice daily on Days 1 to 28 in combination with pulse dosing of TMZ 100 mg once daily on Days 1 to 7 within a 28-day cycle
Dose Escalation: Pamiparib + TMZ 120 mg (Days 1-7)
n=3 Participants
Pamiparib 60 mg twice daily on Days 1 to 28 in combination with pulse dosing of TMZ 120 mg once daily on Days 1 to 7 within a 28-day cycle
Dose Escalation: Pamiparib + TMZ 40 mg (Days 1-14)
n=14 Participants
Pamiparib 60 mg twice daily on Days 1 to 28 in combination with pulse dosing of TMZ 40 mg once daily on Days 1 to 14 within a 28-day cycle
Dose Escalation: Pamiparib + TMZ 20 mg (Days 1-28)
n=14 Participants
Pamiparib 60 mg twice daily in combination with TMZ 20 mg once daily administered continuously on Days 1 to 28 within a 28-day cycle
Dose Escalation: Pamiparib + TMZ 40 mg (Days 1-28)
n=6 Participants
Pamiparib 60 mg twice daily in combination with TMZ 40 mg once daily administered continuously on Days 1 to 28 within a 28-day cycle
Dose Expansion: Gastric Cancer
n=21 Participants
Participants with gastric or gastroesophageal junction cancer received TMZ 60 mg once daily administered on Days 1 to 7 in combination with pamiparib 60 mg twice daily on Days 1 to 28 of each cycle
Dose Expansion: Ovarian Cancer
n=4 Participants
Participants with ovarian cancer, fallopian cancer, or primary peritoneal cancer received TMZ 60 mg once daily administered on Days 1 to 7 in combination with pamiparib 60 mg twice daily on Days 1 to 28 of each cycle
Dose Expansion: SCLC
n=22 Participants
Participants with Small Cell Lung Cancer (SCLC) received TMZ 60 mg once daily administered on Days 1 to 7 in combination with pamiparib 60 mg twice daily on Days 1 to 28 of each cycle
Dose Expansion: TNBC
n=1 Participants
Participants with triple negative breast cancer (TNBC) received TMZ 60 mg once daily administered on Days 1 to 7 in combination with pamiparib 60 mg twice daily on Days 1 to 28 of each cycle
Dose Expansion: Other HRD+ Cancers
n=25 Participants
Participants with non-small cell lung cancer (NSCLC), esophageal cancer, squamous head and neck cancer, or soft tissue sarcomas whose tumors are homologous recombination deficiency (HRD)+ received TMZ 60 mg once daily administered on Days 1 to 7 in combination with pamiparib 60 mg twice daily on Days 1 to 28 of each cycle
Number of Participants Experiencing Adverse Events (AEs)
Participants With At Least 1 TEAE
4 Participants
13 Participants
9 Participants
3 Participants
3 Participants
14 Participants
14 Participants
6 Participants
20 Participants
4 Participants
22 Participants
1 Participants
24 Participants
Number of Participants Experiencing Adverse Events (AEs)
Participants with Serious TEAEs
1 Participants
4 Participants
1 Participants
2 Participants
2 Participants
5 Participants
5 Participants
0 Participants
9 Participants
3 Participants
9 Participants
0 Participants
9 Participants

PRIMARY outcome

Timeframe: Up to approximately 5 years and 10 months

Population: The Efficacy Analysis Set included all participants who were in the safety analysis set, had measurable disease at baseline and had at least one postbaseline tumor assessment unless discontinued treatment due to clinical progression or death prior to tumor assessment.

ORR is defined as the percentage of participants who have a best overall response (BOR) of complete response (CR) or partial response (PR) based on investigator assessment using Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1, where BOR is defined as the best response recorded from the first postbaseline tumor assessment until data cutoff date, disease progression or start of new anticancer treatment.

Outcome measures

Outcome measures
Measure
Dose Escalation: Pamiparib + Temozolomide (TMZ) 40 mg (Days 1-7)
n=3 Participants
Pamiparib 60 mg twice daily on Days 1 to 28 in combination with pulse dosing of TMZ 40 mg once daily on Days 1 to 7 within a 28-day cycle
Dose Escalation: Pamiparib + TMZ 60 mg (Days 1-7)
n=12 Participants
Pamiparib 60 mg twice daily on Days 1 to 28 in combination with pulse dosing of TMZ 60 mg once daily on Days 1 to 7 within a 28-day cycle
Dose Escalation: Pamiparib + TMZ 80 mg (Days 1-7)
n=8 Participants
Pamiparib 60 mg twice daily on Days 1 to 28 in combination with pulse dosing of TMZ 80 mg once daily on Days 1 to 7 within a 28-day cycle
Dose Escalation: Pamiparib + TMZ 100 mg (Days 1-7)
n=2 Participants
Pamiparib 60 mg twice daily on Days 1 to 28 in combination with pulse dosing of TMZ 100 mg once daily on Days 1 to 7 within a 28-day cycle
Dose Escalation: Pamiparib + TMZ 120 mg (Days 1-7)
n=2 Participants
Pamiparib 60 mg twice daily on Days 1 to 28 in combination with pulse dosing of TMZ 120 mg once daily on Days 1 to 7 within a 28-day cycle
Dose Escalation: Pamiparib + TMZ 40 mg (Days 1-14)
n=14 Participants
Pamiparib 60 mg twice daily on Days 1 to 28 in combination with pulse dosing of TMZ 40 mg once daily on Days 1 to 14 within a 28-day cycle
Dose Escalation: Pamiparib + TMZ 20 mg (Days 1-28)
n=13 Participants
Pamiparib 60 mg twice daily in combination with TMZ 20 mg once daily administered continuously on Days 1 to 28 within a 28-day cycle
Dose Escalation: Pamiparib + TMZ 40 mg (Days 1-28)
n=4 Participants
Pamiparib 60 mg twice daily in combination with TMZ 40 mg once daily administered continuously on Days 1 to 28 within a 28-day cycle
Dose Expansion: Gastric Cancer
n=19 Participants
Participants with gastric or gastroesophageal junction cancer received TMZ 60 mg once daily administered on Days 1 to 7 in combination with pamiparib 60 mg twice daily on Days 1 to 28 of each cycle
Dose Expansion: Ovarian Cancer
n=4 Participants
Participants with ovarian cancer, fallopian cancer, or primary peritoneal cancer received TMZ 60 mg once daily administered on Days 1 to 7 in combination with pamiparib 60 mg twice daily on Days 1 to 28 of each cycle
Dose Expansion: SCLC
n=20 Participants
Participants with Small Cell Lung Cancer (SCLC) received TMZ 60 mg once daily administered on Days 1 to 7 in combination with pamiparib 60 mg twice daily on Days 1 to 28 of each cycle
Dose Expansion: TNBC
n=1 Participants
Participants with triple negative breast cancer (TNBC) received TMZ 60 mg once daily administered on Days 1 to 7 in combination with pamiparib 60 mg twice daily on Days 1 to 28 of each cycle
Dose Expansion: Other HRD+ Cancers
n=25 Participants
Participants with non-small cell lung cancer (NSCLC), esophageal cancer, squamous head and neck cancer, or soft tissue sarcomas whose tumors are homologous recombination deficiency (HRD)+ received TMZ 60 mg once daily administered on Days 1 to 7 in combination with pamiparib 60 mg twice daily on Days 1 to 28 of each cycle
Objective Response Rate (ORR)
0.0 percentage of participants
Interval 0.0 to 63.2
16.7 percentage of participants
Interval 3.0 to 43.8
25.0 percentage of participants
Interval 4.6 to 60.0
0.0 percentage of participants
Interval 0.0 to 77.6
0.0 percentage of participants
Interval 0.0 to 77.6
21.4 percentage of participants
Interval 6.1 to 46.6
0.0 percentage of participants
Interval 0.0 to 20.6
25.0 percentage of participants
Interval 1.3 to 75.1
0.0 percentage of participants
Interval 0.0 to 14.6
50.0 percentage of participants
Interval 9.8 to 90.2
15.0 percentage of participants
Interval 4.2 to 34.4
100.0 percentage of participants
Interval 5.0 to 100.0
8.0 percentage of participants
Interval 1.4 to 23.1

SECONDARY outcome

Timeframe: 2 days before Cycle 1 Day 1 (Day -2) at predose, 30 min, 1, 2, 4, 6, 24, and 48 hours after dosing, and on Cycle 1 Day 15 at predose, 1, 2, and 4 hours postdose (each cycle is 28 days)

Population: The pamiparib pharmacokinetic analysis included the first 20 participants enrolled in the dose escalation phase; per the prespecified analysis, participants were analyzed in one group, regardless of dose of TMZ they received. Only 13 participants had data available for calculation of Cmax on Day 15.

Pamiparib pharmakokinetic (PK) parameters were assessed in the first 20 participants enrolled in the dose escalation phase after a single dose on Day -2 and at steady state in combination with TMZ on Day 15.

Outcome measures

Outcome measures
Measure
Dose Escalation: Pamiparib + Temozolomide (TMZ) 40 mg (Days 1-7)
n=20 Participants
Pamiparib 60 mg twice daily on Days 1 to 28 in combination with pulse dosing of TMZ 40 mg once daily on Days 1 to 7 within a 28-day cycle
Dose Escalation: Pamiparib + TMZ 60 mg (Days 1-7)
Pamiparib 60 mg twice daily on Days 1 to 28 in combination with pulse dosing of TMZ 60 mg once daily on Days 1 to 7 within a 28-day cycle
Dose Escalation: Pamiparib + TMZ 80 mg (Days 1-7)
Pamiparib 60 mg twice daily on Days 1 to 28 in combination with pulse dosing of TMZ 80 mg once daily on Days 1 to 7 within a 28-day cycle
Dose Escalation: Pamiparib + TMZ 100 mg (Days 1-7)
Pamiparib 60 mg twice daily on Days 1 to 28 in combination with pulse dosing of TMZ 100 mg once daily on Days 1 to 7 within a 28-day cycle
Dose Escalation: Pamiparib + TMZ 120 mg (Days 1-7)
Pamiparib 60 mg twice daily on Days 1 to 28 in combination with pulse dosing of TMZ 120 mg once daily on Days 1 to 7 within a 28-day cycle
Dose Escalation: Pamiparib + TMZ 40 mg (Days 1-14)
Pamiparib 60 mg twice daily on Days 1 to 28 in combination with pulse dosing of TMZ 40 mg once daily on Days 1 to 14 within a 28-day cycle
Dose Escalation: Pamiparib + TMZ 20 mg (Days 1-28)
Pamiparib 60 mg twice daily in combination with TMZ 20 mg once daily administered continuously on Days 1 to 28 within a 28-day cycle
Dose Escalation: Pamiparib + TMZ 40 mg (Days 1-28)
Pamiparib 60 mg twice daily in combination with TMZ 40 mg once daily administered continuously on Days 1 to 28 within a 28-day cycle
Dose Expansion: Gastric Cancer
Participants with gastric or gastroesophageal junction cancer received TMZ 60 mg once daily administered on Days 1 to 7 in combination with pamiparib 60 mg twice daily on Days 1 to 28 of each cycle
Dose Expansion: Ovarian Cancer
Participants with ovarian cancer, fallopian cancer, or primary peritoneal cancer received TMZ 60 mg once daily administered on Days 1 to 7 in combination with pamiparib 60 mg twice daily on Days 1 to 28 of each cycle
Dose Expansion: SCLC
Participants with Small Cell Lung Cancer (SCLC) received TMZ 60 mg once daily administered on Days 1 to 7 in combination with pamiparib 60 mg twice daily on Days 1 to 28 of each cycle
Dose Expansion: TNBC
Participants with triple negative breast cancer (TNBC) received TMZ 60 mg once daily administered on Days 1 to 7 in combination with pamiparib 60 mg twice daily on Days 1 to 28 of each cycle
Dose Expansion: Other HRD+ Cancers
Participants with non-small cell lung cancer (NSCLC), esophageal cancer, squamous head and neck cancer, or soft tissue sarcomas whose tumors are homologous recombination deficiency (HRD)+ received TMZ 60 mg once daily administered on Days 1 to 7 in combination with pamiparib 60 mg twice daily on Days 1 to 28 of each cycle
Maximum Observed Plasma Concentration (Cmax) of Pamiparib
Day -2
1945.31 ng/mL
Geometric Coefficient of Variation 25
Maximum Observed Plasma Concentration (Cmax) of Pamiparib
Cycle 1 Day 15
3796.06 ng/mL
Geometric Coefficient of Variation 33

SECONDARY outcome

Timeframe: Cycle 1 Day 15 predose

Population: The pamiparib pharmacokinetic analysis included the first 20 participants enrolled in the dose escalation phase; per the prespecified analysis, participants were analyzed in one group, regardless of dose of TMZ they received. Only 14 participants had data available for calculation of Ctrough on Day 15.

Outcome measures

Outcome measures
Measure
Dose Escalation: Pamiparib + Temozolomide (TMZ) 40 mg (Days 1-7)
n=14 Participants
Pamiparib 60 mg twice daily on Days 1 to 28 in combination with pulse dosing of TMZ 40 mg once daily on Days 1 to 7 within a 28-day cycle
Dose Escalation: Pamiparib + TMZ 60 mg (Days 1-7)
Pamiparib 60 mg twice daily on Days 1 to 28 in combination with pulse dosing of TMZ 60 mg once daily on Days 1 to 7 within a 28-day cycle
Dose Escalation: Pamiparib + TMZ 80 mg (Days 1-7)
Pamiparib 60 mg twice daily on Days 1 to 28 in combination with pulse dosing of TMZ 80 mg once daily on Days 1 to 7 within a 28-day cycle
Dose Escalation: Pamiparib + TMZ 100 mg (Days 1-7)
Pamiparib 60 mg twice daily on Days 1 to 28 in combination with pulse dosing of TMZ 100 mg once daily on Days 1 to 7 within a 28-day cycle
Dose Escalation: Pamiparib + TMZ 120 mg (Days 1-7)
Pamiparib 60 mg twice daily on Days 1 to 28 in combination with pulse dosing of TMZ 120 mg once daily on Days 1 to 7 within a 28-day cycle
Dose Escalation: Pamiparib + TMZ 40 mg (Days 1-14)
Pamiparib 60 mg twice daily on Days 1 to 28 in combination with pulse dosing of TMZ 40 mg once daily on Days 1 to 14 within a 28-day cycle
Dose Escalation: Pamiparib + TMZ 20 mg (Days 1-28)
Pamiparib 60 mg twice daily in combination with TMZ 20 mg once daily administered continuously on Days 1 to 28 within a 28-day cycle
Dose Escalation: Pamiparib + TMZ 40 mg (Days 1-28)
Pamiparib 60 mg twice daily in combination with TMZ 40 mg once daily administered continuously on Days 1 to 28 within a 28-day cycle
Dose Expansion: Gastric Cancer
Participants with gastric or gastroesophageal junction cancer received TMZ 60 mg once daily administered on Days 1 to 7 in combination with pamiparib 60 mg twice daily on Days 1 to 28 of each cycle
Dose Expansion: Ovarian Cancer
Participants with ovarian cancer, fallopian cancer, or primary peritoneal cancer received TMZ 60 mg once daily administered on Days 1 to 7 in combination with pamiparib 60 mg twice daily on Days 1 to 28 of each cycle
Dose Expansion: SCLC
Participants with Small Cell Lung Cancer (SCLC) received TMZ 60 mg once daily administered on Days 1 to 7 in combination with pamiparib 60 mg twice daily on Days 1 to 28 of each cycle
Dose Expansion: TNBC
Participants with triple negative breast cancer (TNBC) received TMZ 60 mg once daily administered on Days 1 to 7 in combination with pamiparib 60 mg twice daily on Days 1 to 28 of each cycle
Dose Expansion: Other HRD+ Cancers
Participants with non-small cell lung cancer (NSCLC), esophageal cancer, squamous head and neck cancer, or soft tissue sarcomas whose tumors are homologous recombination deficiency (HRD)+ received TMZ 60 mg once daily administered on Days 1 to 7 in combination with pamiparib 60 mg twice daily on Days 1 to 28 of each cycle
Plasma Trough Concentrations of Pamiparib (Ctrough)
2335.6 ng/mL
Geometric Coefficient of Variation 76

SECONDARY outcome

Timeframe: 2 days before Cycle 1 Day 1 (Day -2) at predose, 30 min, 1, 2, 4, 6, 24, and 48 hours after dosing, and on Cycle 1 Day 15 at predose, 1, 2, and 4 hours postdose.

Population: The pamiparib pharmacokinetic analysis included the first 20 participants enrolled in the dose escalation phase; per the prespecified analysis, participants were analyzed in one group, regardless of dose of TMZ they received. Only 13 participants had data available for calculation of Tmax on Day 15.

Outcome measures

Outcome measures
Measure
Dose Escalation: Pamiparib + Temozolomide (TMZ) 40 mg (Days 1-7)
n=20 Participants
Pamiparib 60 mg twice daily on Days 1 to 28 in combination with pulse dosing of TMZ 40 mg once daily on Days 1 to 7 within a 28-day cycle
Dose Escalation: Pamiparib + TMZ 60 mg (Days 1-7)
Pamiparib 60 mg twice daily on Days 1 to 28 in combination with pulse dosing of TMZ 60 mg once daily on Days 1 to 7 within a 28-day cycle
Dose Escalation: Pamiparib + TMZ 80 mg (Days 1-7)
Pamiparib 60 mg twice daily on Days 1 to 28 in combination with pulse dosing of TMZ 80 mg once daily on Days 1 to 7 within a 28-day cycle
Dose Escalation: Pamiparib + TMZ 100 mg (Days 1-7)
Pamiparib 60 mg twice daily on Days 1 to 28 in combination with pulse dosing of TMZ 100 mg once daily on Days 1 to 7 within a 28-day cycle
Dose Escalation: Pamiparib + TMZ 120 mg (Days 1-7)
Pamiparib 60 mg twice daily on Days 1 to 28 in combination with pulse dosing of TMZ 120 mg once daily on Days 1 to 7 within a 28-day cycle
Dose Escalation: Pamiparib + TMZ 40 mg (Days 1-14)
Pamiparib 60 mg twice daily on Days 1 to 28 in combination with pulse dosing of TMZ 40 mg once daily on Days 1 to 14 within a 28-day cycle
Dose Escalation: Pamiparib + TMZ 20 mg (Days 1-28)
Pamiparib 60 mg twice daily in combination with TMZ 20 mg once daily administered continuously on Days 1 to 28 within a 28-day cycle
Dose Escalation: Pamiparib + TMZ 40 mg (Days 1-28)
Pamiparib 60 mg twice daily in combination with TMZ 40 mg once daily administered continuously on Days 1 to 28 within a 28-day cycle
Dose Expansion: Gastric Cancer
Participants with gastric or gastroesophageal junction cancer received TMZ 60 mg once daily administered on Days 1 to 7 in combination with pamiparib 60 mg twice daily on Days 1 to 28 of each cycle
Dose Expansion: Ovarian Cancer
Participants with ovarian cancer, fallopian cancer, or primary peritoneal cancer received TMZ 60 mg once daily administered on Days 1 to 7 in combination with pamiparib 60 mg twice daily on Days 1 to 28 of each cycle
Dose Expansion: SCLC
Participants with Small Cell Lung Cancer (SCLC) received TMZ 60 mg once daily administered on Days 1 to 7 in combination with pamiparib 60 mg twice daily on Days 1 to 28 of each cycle
Dose Expansion: TNBC
Participants with triple negative breast cancer (TNBC) received TMZ 60 mg once daily administered on Days 1 to 7 in combination with pamiparib 60 mg twice daily on Days 1 to 28 of each cycle
Dose Expansion: Other HRD+ Cancers
Participants with non-small cell lung cancer (NSCLC), esophageal cancer, squamous head and neck cancer, or soft tissue sarcomas whose tumors are homologous recombination deficiency (HRD)+ received TMZ 60 mg once daily administered on Days 1 to 7 in combination with pamiparib 60 mg twice daily on Days 1 to 28 of each cycle
Time to Reach Cmax (Tmax) of Pamiparib
Day -2
2.00 hours
Interval 1.0 to 23.92
Time to Reach Cmax (Tmax) of Pamiparib
Cycle 1 Day 15
1.83 hours
Interval 0.83 to 2.17

SECONDARY outcome

Timeframe: 2 days before Cycle 1 Day 1 (Day -2) at predose, 30 min, 1, 2, and 4 hours after dosing, and on Cycle 1 Day 15 at predose, 1, 2, and 4 hours postdose.

Population: The pamiparib pharmacokinetic analysis included the first 20 participants enrolled in the dose escalation phase; per the prespecified analysis participants were analyzed in one group, regardless of dose of TMZ they received. Only 8 participants had available data to calculate AUC0-4 on Day 15.

Outcome measures

Outcome measures
Measure
Dose Escalation: Pamiparib + Temozolomide (TMZ) 40 mg (Days 1-7)
n=20 Participants
Pamiparib 60 mg twice daily on Days 1 to 28 in combination with pulse dosing of TMZ 40 mg once daily on Days 1 to 7 within a 28-day cycle
Dose Escalation: Pamiparib + TMZ 60 mg (Days 1-7)
Pamiparib 60 mg twice daily on Days 1 to 28 in combination with pulse dosing of TMZ 60 mg once daily on Days 1 to 7 within a 28-day cycle
Dose Escalation: Pamiparib + TMZ 80 mg (Days 1-7)
Pamiparib 60 mg twice daily on Days 1 to 28 in combination with pulse dosing of TMZ 80 mg once daily on Days 1 to 7 within a 28-day cycle
Dose Escalation: Pamiparib + TMZ 100 mg (Days 1-7)
Pamiparib 60 mg twice daily on Days 1 to 28 in combination with pulse dosing of TMZ 100 mg once daily on Days 1 to 7 within a 28-day cycle
Dose Escalation: Pamiparib + TMZ 120 mg (Days 1-7)
Pamiparib 60 mg twice daily on Days 1 to 28 in combination with pulse dosing of TMZ 120 mg once daily on Days 1 to 7 within a 28-day cycle
Dose Escalation: Pamiparib + TMZ 40 mg (Days 1-14)
Pamiparib 60 mg twice daily on Days 1 to 28 in combination with pulse dosing of TMZ 40 mg once daily on Days 1 to 14 within a 28-day cycle
Dose Escalation: Pamiparib + TMZ 20 mg (Days 1-28)
Pamiparib 60 mg twice daily in combination with TMZ 20 mg once daily administered continuously on Days 1 to 28 within a 28-day cycle
Dose Escalation: Pamiparib + TMZ 40 mg (Days 1-28)
Pamiparib 60 mg twice daily in combination with TMZ 40 mg once daily administered continuously on Days 1 to 28 within a 28-day cycle
Dose Expansion: Gastric Cancer
Participants with gastric or gastroesophageal junction cancer received TMZ 60 mg once daily administered on Days 1 to 7 in combination with pamiparib 60 mg twice daily on Days 1 to 28 of each cycle
Dose Expansion: Ovarian Cancer
Participants with ovarian cancer, fallopian cancer, or primary peritoneal cancer received TMZ 60 mg once daily administered on Days 1 to 7 in combination with pamiparib 60 mg twice daily on Days 1 to 28 of each cycle
Dose Expansion: SCLC
Participants with Small Cell Lung Cancer (SCLC) received TMZ 60 mg once daily administered on Days 1 to 7 in combination with pamiparib 60 mg twice daily on Days 1 to 28 of each cycle
Dose Expansion: TNBC
Participants with triple negative breast cancer (TNBC) received TMZ 60 mg once daily administered on Days 1 to 7 in combination with pamiparib 60 mg twice daily on Days 1 to 28 of each cycle
Dose Expansion: Other HRD+ Cancers
Participants with non-small cell lung cancer (NSCLC), esophageal cancer, squamous head and neck cancer, or soft tissue sarcomas whose tumors are homologous recombination deficiency (HRD)+ received TMZ 60 mg once daily administered on Days 1 to 7 in combination with pamiparib 60 mg twice daily on Days 1 to 28 of each cycle
Area Under the Curve From Time 0 to 4 Hours (AUC0-4h) of Pamiparib
Day -2
4646.4 h*ng/mL
Geometric Coefficient of Variation 45
Area Under the Curve From Time 0 to 4 Hours (AUC0-4h) of Pamiparib
Cycle 1 Day 15
11119.5 h*ng/mL
Geometric Coefficient of Variation 41

SECONDARY outcome

Timeframe: 2 days before Cycle 1 Day 1 (Day -2) at predose, 30 min, 1, 2, 4, 6, 24, and 48 hours after dosing

Population: The pamiparib pharmacokinetic analysis included the first 20 participants enrolled in the dose escalation phase; AUC0-inf could only be calculated for 15 participants.

Outcome measures

Outcome measures
Measure
Dose Escalation: Pamiparib + Temozolomide (TMZ) 40 mg (Days 1-7)
n=15 Participants
Pamiparib 60 mg twice daily on Days 1 to 28 in combination with pulse dosing of TMZ 40 mg once daily on Days 1 to 7 within a 28-day cycle
Dose Escalation: Pamiparib + TMZ 60 mg (Days 1-7)
Pamiparib 60 mg twice daily on Days 1 to 28 in combination with pulse dosing of TMZ 60 mg once daily on Days 1 to 7 within a 28-day cycle
Dose Escalation: Pamiparib + TMZ 80 mg (Days 1-7)
Pamiparib 60 mg twice daily on Days 1 to 28 in combination with pulse dosing of TMZ 80 mg once daily on Days 1 to 7 within a 28-day cycle
Dose Escalation: Pamiparib + TMZ 100 mg (Days 1-7)
Pamiparib 60 mg twice daily on Days 1 to 28 in combination with pulse dosing of TMZ 100 mg once daily on Days 1 to 7 within a 28-day cycle
Dose Escalation: Pamiparib + TMZ 120 mg (Days 1-7)
Pamiparib 60 mg twice daily on Days 1 to 28 in combination with pulse dosing of TMZ 120 mg once daily on Days 1 to 7 within a 28-day cycle
Dose Escalation: Pamiparib + TMZ 40 mg (Days 1-14)
Pamiparib 60 mg twice daily on Days 1 to 28 in combination with pulse dosing of TMZ 40 mg once daily on Days 1 to 14 within a 28-day cycle
Dose Escalation: Pamiparib + TMZ 20 mg (Days 1-28)
Pamiparib 60 mg twice daily in combination with TMZ 20 mg once daily administered continuously on Days 1 to 28 within a 28-day cycle
Dose Escalation: Pamiparib + TMZ 40 mg (Days 1-28)
Pamiparib 60 mg twice daily in combination with TMZ 40 mg once daily administered continuously on Days 1 to 28 within a 28-day cycle
Dose Expansion: Gastric Cancer
Participants with gastric or gastroesophageal junction cancer received TMZ 60 mg once daily administered on Days 1 to 7 in combination with pamiparib 60 mg twice daily on Days 1 to 28 of each cycle
Dose Expansion: Ovarian Cancer
Participants with ovarian cancer, fallopian cancer, or primary peritoneal cancer received TMZ 60 mg once daily administered on Days 1 to 7 in combination with pamiparib 60 mg twice daily on Days 1 to 28 of each cycle
Dose Expansion: SCLC
Participants with Small Cell Lung Cancer (SCLC) received TMZ 60 mg once daily administered on Days 1 to 7 in combination with pamiparib 60 mg twice daily on Days 1 to 28 of each cycle
Dose Expansion: TNBC
Participants with triple negative breast cancer (TNBC) received TMZ 60 mg once daily administered on Days 1 to 7 in combination with pamiparib 60 mg twice daily on Days 1 to 28 of each cycle
Dose Expansion: Other HRD+ Cancers
Participants with non-small cell lung cancer (NSCLC), esophageal cancer, squamous head and neck cancer, or soft tissue sarcomas whose tumors are homologous recombination deficiency (HRD)+ received TMZ 60 mg once daily administered on Days 1 to 7 in combination with pamiparib 60 mg twice daily on Days 1 to 28 of each cycle
Area Under the Curve From Time 0 to Infinity (AUC0-inf) of Pamiparib
25287.0 h*ng/mL
Geometric Coefficient of Variation 50

SECONDARY outcome

Timeframe: 2 days before Cycle 1 Day 1 (Day -2) at predose, 30 min, 1, 2, 4, 6, 24, and 48 hours after dosing (each cycle is 28 days)

Population: The pamiparib pharmacokinetic analysis included the first 20 participants enrolled in the dose escalation phase; Only 17 participants had data available to calculate T1/2.

Outcome measures

Outcome measures
Measure
Dose Escalation: Pamiparib + Temozolomide (TMZ) 40 mg (Days 1-7)
n=17 Participants
Pamiparib 60 mg twice daily on Days 1 to 28 in combination with pulse dosing of TMZ 40 mg once daily on Days 1 to 7 within a 28-day cycle
Dose Escalation: Pamiparib + TMZ 60 mg (Days 1-7)
Pamiparib 60 mg twice daily on Days 1 to 28 in combination with pulse dosing of TMZ 60 mg once daily on Days 1 to 7 within a 28-day cycle
Dose Escalation: Pamiparib + TMZ 80 mg (Days 1-7)
Pamiparib 60 mg twice daily on Days 1 to 28 in combination with pulse dosing of TMZ 80 mg once daily on Days 1 to 7 within a 28-day cycle
Dose Escalation: Pamiparib + TMZ 100 mg (Days 1-7)
Pamiparib 60 mg twice daily on Days 1 to 28 in combination with pulse dosing of TMZ 100 mg once daily on Days 1 to 7 within a 28-day cycle
Dose Escalation: Pamiparib + TMZ 120 mg (Days 1-7)
Pamiparib 60 mg twice daily on Days 1 to 28 in combination with pulse dosing of TMZ 120 mg once daily on Days 1 to 7 within a 28-day cycle
Dose Escalation: Pamiparib + TMZ 40 mg (Days 1-14)
Pamiparib 60 mg twice daily on Days 1 to 28 in combination with pulse dosing of TMZ 40 mg once daily on Days 1 to 14 within a 28-day cycle
Dose Escalation: Pamiparib + TMZ 20 mg (Days 1-28)
Pamiparib 60 mg twice daily in combination with TMZ 20 mg once daily administered continuously on Days 1 to 28 within a 28-day cycle
Dose Escalation: Pamiparib + TMZ 40 mg (Days 1-28)
Pamiparib 60 mg twice daily in combination with TMZ 40 mg once daily administered continuously on Days 1 to 28 within a 28-day cycle
Dose Expansion: Gastric Cancer
Participants with gastric or gastroesophageal junction cancer received TMZ 60 mg once daily administered on Days 1 to 7 in combination with pamiparib 60 mg twice daily on Days 1 to 28 of each cycle
Dose Expansion: Ovarian Cancer
Participants with ovarian cancer, fallopian cancer, or primary peritoneal cancer received TMZ 60 mg once daily administered on Days 1 to 7 in combination with pamiparib 60 mg twice daily on Days 1 to 28 of each cycle
Dose Expansion: SCLC
Participants with Small Cell Lung Cancer (SCLC) received TMZ 60 mg once daily administered on Days 1 to 7 in combination with pamiparib 60 mg twice daily on Days 1 to 28 of each cycle
Dose Expansion: TNBC
Participants with triple negative breast cancer (TNBC) received TMZ 60 mg once daily administered on Days 1 to 7 in combination with pamiparib 60 mg twice daily on Days 1 to 28 of each cycle
Dose Expansion: Other HRD+ Cancers
Participants with non-small cell lung cancer (NSCLC), esophageal cancer, squamous head and neck cancer, or soft tissue sarcomas whose tumors are homologous recombination deficiency (HRD)+ received TMZ 60 mg once daily administered on Days 1 to 7 in combination with pamiparib 60 mg twice daily on Days 1 to 28 of each cycle
Terminal Elimination Half-life (t1/2) of Pamiparib
11.82 hours
Interval 5.94 to 33.58

SECONDARY outcome

Timeframe: 2 days before Cycle 1 Day 1 (Day -2) at predose, 30 min, 1, 2, 4, 6, 24, and 48 hours after dosing (each cycle is 28 days)

Population: The pamiparib pharmacokinetic analysis included the first 20 participants enrolled in the dose escalation phase; Only 15 participants had data available to calculate CL/F.

Outcome measures

Outcome measures
Measure
Dose Escalation: Pamiparib + Temozolomide (TMZ) 40 mg (Days 1-7)
n=15 Participants
Pamiparib 60 mg twice daily on Days 1 to 28 in combination with pulse dosing of TMZ 40 mg once daily on Days 1 to 7 within a 28-day cycle
Dose Escalation: Pamiparib + TMZ 60 mg (Days 1-7)
Pamiparib 60 mg twice daily on Days 1 to 28 in combination with pulse dosing of TMZ 60 mg once daily on Days 1 to 7 within a 28-day cycle
Dose Escalation: Pamiparib + TMZ 80 mg (Days 1-7)
Pamiparib 60 mg twice daily on Days 1 to 28 in combination with pulse dosing of TMZ 80 mg once daily on Days 1 to 7 within a 28-day cycle
Dose Escalation: Pamiparib + TMZ 100 mg (Days 1-7)
Pamiparib 60 mg twice daily on Days 1 to 28 in combination with pulse dosing of TMZ 100 mg once daily on Days 1 to 7 within a 28-day cycle
Dose Escalation: Pamiparib + TMZ 120 mg (Days 1-7)
Pamiparib 60 mg twice daily on Days 1 to 28 in combination with pulse dosing of TMZ 120 mg once daily on Days 1 to 7 within a 28-day cycle
Dose Escalation: Pamiparib + TMZ 40 mg (Days 1-14)
Pamiparib 60 mg twice daily on Days 1 to 28 in combination with pulse dosing of TMZ 40 mg once daily on Days 1 to 14 within a 28-day cycle
Dose Escalation: Pamiparib + TMZ 20 mg (Days 1-28)
Pamiparib 60 mg twice daily in combination with TMZ 20 mg once daily administered continuously on Days 1 to 28 within a 28-day cycle
Dose Escalation: Pamiparib + TMZ 40 mg (Days 1-28)
Pamiparib 60 mg twice daily in combination with TMZ 40 mg once daily administered continuously on Days 1 to 28 within a 28-day cycle
Dose Expansion: Gastric Cancer
Participants with gastric or gastroesophageal junction cancer received TMZ 60 mg once daily administered on Days 1 to 7 in combination with pamiparib 60 mg twice daily on Days 1 to 28 of each cycle
Dose Expansion: Ovarian Cancer
Participants with ovarian cancer, fallopian cancer, or primary peritoneal cancer received TMZ 60 mg once daily administered on Days 1 to 7 in combination with pamiparib 60 mg twice daily on Days 1 to 28 of each cycle
Dose Expansion: SCLC
Participants with Small Cell Lung Cancer (SCLC) received TMZ 60 mg once daily administered on Days 1 to 7 in combination with pamiparib 60 mg twice daily on Days 1 to 28 of each cycle
Dose Expansion: TNBC
Participants with triple negative breast cancer (TNBC) received TMZ 60 mg once daily administered on Days 1 to 7 in combination with pamiparib 60 mg twice daily on Days 1 to 28 of each cycle
Dose Expansion: Other HRD+ Cancers
Participants with non-small cell lung cancer (NSCLC), esophageal cancer, squamous head and neck cancer, or soft tissue sarcomas whose tumors are homologous recombination deficiency (HRD)+ received TMZ 60 mg once daily administered on Days 1 to 7 in combination with pamiparib 60 mg twice daily on Days 1 to 28 of each cycle
Apparent Clearance (CL/F) of Pamiparib
2.37 L/h
Geometric Coefficient of Variation 50

SECONDARY outcome

Timeframe: 2 days before Cycle 1 Day 1 (Day -2) at predose, 30 min, 1, 2, 4, 6, 24, and 48 hours after dosing (each cycle is 28 days)

Population: The pamiparib pharmacokinetic analysis included the first 20 participants enrolled in the dose escalation phase; Only 15 participants had data available to calculate Vz/F.

Outcome measures

Outcome measures
Measure
Dose Escalation: Pamiparib + Temozolomide (TMZ) 40 mg (Days 1-7)
n=15 Participants
Pamiparib 60 mg twice daily on Days 1 to 28 in combination with pulse dosing of TMZ 40 mg once daily on Days 1 to 7 within a 28-day cycle
Dose Escalation: Pamiparib + TMZ 60 mg (Days 1-7)
Pamiparib 60 mg twice daily on Days 1 to 28 in combination with pulse dosing of TMZ 60 mg once daily on Days 1 to 7 within a 28-day cycle
Dose Escalation: Pamiparib + TMZ 80 mg (Days 1-7)
Pamiparib 60 mg twice daily on Days 1 to 28 in combination with pulse dosing of TMZ 80 mg once daily on Days 1 to 7 within a 28-day cycle
Dose Escalation: Pamiparib + TMZ 100 mg (Days 1-7)
Pamiparib 60 mg twice daily on Days 1 to 28 in combination with pulse dosing of TMZ 100 mg once daily on Days 1 to 7 within a 28-day cycle
Dose Escalation: Pamiparib + TMZ 120 mg (Days 1-7)
Pamiparib 60 mg twice daily on Days 1 to 28 in combination with pulse dosing of TMZ 120 mg once daily on Days 1 to 7 within a 28-day cycle
Dose Escalation: Pamiparib + TMZ 40 mg (Days 1-14)
Pamiparib 60 mg twice daily on Days 1 to 28 in combination with pulse dosing of TMZ 40 mg once daily on Days 1 to 14 within a 28-day cycle
Dose Escalation: Pamiparib + TMZ 20 mg (Days 1-28)
Pamiparib 60 mg twice daily in combination with TMZ 20 mg once daily administered continuously on Days 1 to 28 within a 28-day cycle
Dose Escalation: Pamiparib + TMZ 40 mg (Days 1-28)
Pamiparib 60 mg twice daily in combination with TMZ 40 mg once daily administered continuously on Days 1 to 28 within a 28-day cycle
Dose Expansion: Gastric Cancer
Participants with gastric or gastroesophageal junction cancer received TMZ 60 mg once daily administered on Days 1 to 7 in combination with pamiparib 60 mg twice daily on Days 1 to 28 of each cycle
Dose Expansion: Ovarian Cancer
Participants with ovarian cancer, fallopian cancer, or primary peritoneal cancer received TMZ 60 mg once daily administered on Days 1 to 7 in combination with pamiparib 60 mg twice daily on Days 1 to 28 of each cycle
Dose Expansion: SCLC
Participants with Small Cell Lung Cancer (SCLC) received TMZ 60 mg once daily administered on Days 1 to 7 in combination with pamiparib 60 mg twice daily on Days 1 to 28 of each cycle
Dose Expansion: TNBC
Participants with triple negative breast cancer (TNBC) received TMZ 60 mg once daily administered on Days 1 to 7 in combination with pamiparib 60 mg twice daily on Days 1 to 28 of each cycle
Dose Expansion: Other HRD+ Cancers
Participants with non-small cell lung cancer (NSCLC), esophageal cancer, squamous head and neck cancer, or soft tissue sarcomas whose tumors are homologous recombination deficiency (HRD)+ received TMZ 60 mg once daily administered on Days 1 to 7 in combination with pamiparib 60 mg twice daily on Days 1 to 28 of each cycle
Apparent Volume of Distribution During Terminal Phase (Vz/F) of Pamiparib
38.14 liters
Geometric Coefficient of Variation 15

SECONDARY outcome

Timeframe: Predose (within 30 min prior to dose) and 1 hour post dose on Cycle 1 Day 1 and Cycle 1 Day 7

Population: PK Analysis Set: includes participants who received any dose of TMZ and contributed at least one plasma concentration.

Outcome measures

Outcome measures
Measure
Dose Escalation: Pamiparib + Temozolomide (TMZ) 40 mg (Days 1-7)
n=14 Participants
Pamiparib 60 mg twice daily on Days 1 to 28 in combination with pulse dosing of TMZ 40 mg once daily on Days 1 to 7 within a 28-day cycle
Dose Escalation: Pamiparib + TMZ 60 mg (Days 1-7)
n=24 Participants
Pamiparib 60 mg twice daily on Days 1 to 28 in combination with pulse dosing of TMZ 60 mg once daily on Days 1 to 7 within a 28-day cycle
Dose Escalation: Pamiparib + TMZ 80 mg (Days 1-7)
n=85 Participants
Pamiparib 60 mg twice daily on Days 1 to 28 in combination with pulse dosing of TMZ 80 mg once daily on Days 1 to 7 within a 28-day cycle
Dose Escalation: Pamiparib + TMZ 100 mg (Days 1-7)
n=9 Participants
Pamiparib 60 mg twice daily on Days 1 to 28 in combination with pulse dosing of TMZ 100 mg once daily on Days 1 to 7 within a 28-day cycle
Dose Escalation: Pamiparib + TMZ 120 mg (Days 1-7)
n=3 Participants
Pamiparib 60 mg twice daily on Days 1 to 28 in combination with pulse dosing of TMZ 120 mg once daily on Days 1 to 7 within a 28-day cycle
Dose Escalation: Pamiparib + TMZ 40 mg (Days 1-14)
n=3 Participants
Pamiparib 60 mg twice daily on Days 1 to 28 in combination with pulse dosing of TMZ 40 mg once daily on Days 1 to 14 within a 28-day cycle
Dose Escalation: Pamiparib + TMZ 20 mg (Days 1-28)
Pamiparib 60 mg twice daily in combination with TMZ 20 mg once daily administered continuously on Days 1 to 28 within a 28-day cycle
Dose Escalation: Pamiparib + TMZ 40 mg (Days 1-28)
Pamiparib 60 mg twice daily in combination with TMZ 40 mg once daily administered continuously on Days 1 to 28 within a 28-day cycle
Dose Expansion: Gastric Cancer
Participants with gastric or gastroesophageal junction cancer received TMZ 60 mg once daily administered on Days 1 to 7 in combination with pamiparib 60 mg twice daily on Days 1 to 28 of each cycle
Dose Expansion: Ovarian Cancer
Participants with ovarian cancer, fallopian cancer, or primary peritoneal cancer received TMZ 60 mg once daily administered on Days 1 to 7 in combination with pamiparib 60 mg twice daily on Days 1 to 28 of each cycle
Dose Expansion: SCLC
Participants with Small Cell Lung Cancer (SCLC) received TMZ 60 mg once daily administered on Days 1 to 7 in combination with pamiparib 60 mg twice daily on Days 1 to 28 of each cycle
Dose Expansion: TNBC
Participants with triple negative breast cancer (TNBC) received TMZ 60 mg once daily administered on Days 1 to 7 in combination with pamiparib 60 mg twice daily on Days 1 to 28 of each cycle
Dose Expansion: Other HRD+ Cancers
Participants with non-small cell lung cancer (NSCLC), esophageal cancer, squamous head and neck cancer, or soft tissue sarcomas whose tumors are homologous recombination deficiency (HRD)+ received TMZ 60 mg once daily administered on Days 1 to 7 in combination with pamiparib 60 mg twice daily on Days 1 to 28 of each cycle
Plasma Concentration of Temozolomide (TMZ)
C1D7 Postdose 1H
340.9 ng/mL
Geometric Coefficient of Variation 86
636.7 ng/mL
Geometric Coefficient of Variation 57
761.1 ng/mL
Geometric Coefficient of Variation 103
1959.8 ng/mL
Geometric Coefficient of Variation 40
1520.0 ng/mL
1775.6 ng/mL
Geometric Coefficient of Variation 71
Plasma Concentration of Temozolomide (TMZ)
C1D1 Predose
NA ng/mL
Geometric Coefficient of Variation NA
All pre-dose concentrations noted as NA were below limit of quantitation
NA ng/mL
Geometric Coefficient of Variation NA
All pre-dose concentrations noted as NA were below limit of quantitation
NA ng/mL
Geometric Coefficient of Variation NA
All pre-dose concentrations noted as NA were below limit of quantitation
NA ng/mL
Geometric Coefficient of Variation NA
All pre-dose concentrations noted as NA were below limit of quantitation
NA ng/mL
Geometric Coefficient of Variation NA
All pre-dose concentrations noted as NA were below limit of quantitation
NA ng/mL
Geometric Coefficient of Variation NA
All pre-dose concentrations noted as NA were below limit of quantitation
Plasma Concentration of Temozolomide (TMZ)
C1D1 Postdose 1H
322.8 ng/mL
Geometric Coefficient of Variation 35
601.3 ng/mL
Geometric Coefficient of Variation 68
822.3 ng/mL
Geometric Coefficient of Variation 74
1366.1 ng/mL
Geometric Coefficient of Variation 46
1157.9 ng/mL
Geometric Coefficient of Variation 123
1464.5 ng/mL
Geometric Coefficient of Variation 31
Plasma Concentration of Temozolomide (TMZ)
C1D7 Predose
NA ng/mL
Geometric Coefficient of Variation NA
All pre-dose concentrations noted as NA were below limit of quantitation
NA ng/mL
Geometric Coefficient of Variation NA
All pre-dose concentrations noted as NA were below limit of quantitation
NA ng/mL
Geometric Coefficient of Variation NA
All pre-dose concentrations noted as NA were below limit of quantitation
NA ng/mL
Geometric Coefficient of Variation NA
All pre-dose concentrations noted as NA were below limit of quantitation
NA ng/mL
Geometric Coefficient of Variation NA
All pre-dose concentrations noted as NA were below limit of quantitation

SECONDARY outcome

Timeframe: Up to approximately 5 years and 10 months

Population: Efficacy Analysis Set

DCR is defined as the percentage of participants with BOR of CR, PR, or stable disease (SD) based on investigator assessment using RECIST v1.1.

Outcome measures

Outcome measures
Measure
Dose Escalation: Pamiparib + Temozolomide (TMZ) 40 mg (Days 1-7)
n=3 Participants
Pamiparib 60 mg twice daily on Days 1 to 28 in combination with pulse dosing of TMZ 40 mg once daily on Days 1 to 7 within a 28-day cycle
Dose Escalation: Pamiparib + TMZ 60 mg (Days 1-7)
n=12 Participants
Pamiparib 60 mg twice daily on Days 1 to 28 in combination with pulse dosing of TMZ 60 mg once daily on Days 1 to 7 within a 28-day cycle
Dose Escalation: Pamiparib + TMZ 80 mg (Days 1-7)
n=8 Participants
Pamiparib 60 mg twice daily on Days 1 to 28 in combination with pulse dosing of TMZ 80 mg once daily on Days 1 to 7 within a 28-day cycle
Dose Escalation: Pamiparib + TMZ 100 mg (Days 1-7)
n=2 Participants
Pamiparib 60 mg twice daily on Days 1 to 28 in combination with pulse dosing of TMZ 100 mg once daily on Days 1 to 7 within a 28-day cycle
Dose Escalation: Pamiparib + TMZ 120 mg (Days 1-7)
n=2 Participants
Pamiparib 60 mg twice daily on Days 1 to 28 in combination with pulse dosing of TMZ 120 mg once daily on Days 1 to 7 within a 28-day cycle
Dose Escalation: Pamiparib + TMZ 40 mg (Days 1-14)
n=14 Participants
Pamiparib 60 mg twice daily on Days 1 to 28 in combination with pulse dosing of TMZ 40 mg once daily on Days 1 to 14 within a 28-day cycle
Dose Escalation: Pamiparib + TMZ 20 mg (Days 1-28)
n=13 Participants
Pamiparib 60 mg twice daily in combination with TMZ 20 mg once daily administered continuously on Days 1 to 28 within a 28-day cycle
Dose Escalation: Pamiparib + TMZ 40 mg (Days 1-28)
n=4 Participants
Pamiparib 60 mg twice daily in combination with TMZ 40 mg once daily administered continuously on Days 1 to 28 within a 28-day cycle
Dose Expansion: Gastric Cancer
n=19 Participants
Participants with gastric or gastroesophageal junction cancer received TMZ 60 mg once daily administered on Days 1 to 7 in combination with pamiparib 60 mg twice daily on Days 1 to 28 of each cycle
Dose Expansion: Ovarian Cancer
n=4 Participants
Participants with ovarian cancer, fallopian cancer, or primary peritoneal cancer received TMZ 60 mg once daily administered on Days 1 to 7 in combination with pamiparib 60 mg twice daily on Days 1 to 28 of each cycle
Dose Expansion: SCLC
n=20 Participants
Participants with Small Cell Lung Cancer (SCLC) received TMZ 60 mg once daily administered on Days 1 to 7 in combination with pamiparib 60 mg twice daily on Days 1 to 28 of each cycle
Dose Expansion: TNBC
n=1 Participants
Participants with triple negative breast cancer (TNBC) received TMZ 60 mg once daily administered on Days 1 to 7 in combination with pamiparib 60 mg twice daily on Days 1 to 28 of each cycle
Dose Expansion: Other HRD+ Cancers
n=25 Participants
Participants with non-small cell lung cancer (NSCLC), esophageal cancer, squamous head and neck cancer, or soft tissue sarcomas whose tumors are homologous recombination deficiency (HRD)+ received TMZ 60 mg once daily administered on Days 1 to 7 in combination with pamiparib 60 mg twice daily on Days 1 to 28 of each cycle
Disease Control Rate (DCR)
33.3 percentage of participants
Interval 1.7 to 86.5
91.7 percentage of participants
Interval 66.1 to 99.6
75.0 percentage of participants
Interval 40.0 to 95.4
100.0 percentage of participants
Interval 22.4 to 100.0
50.0 percentage of participants
Interval 2.5 to 97.5
42.9 percentage of participants
Interval 20.6 to 67.5
53.8 percentage of participants
Interval 28.7 to 77.6
75.0 percentage of participants
Interval 24.9 to 98.7
42.1 percentage of participants
Interval 23.0 to 63.2
75.0 percentage of participants
Interval 24.9 to 98.7
75.0 percentage of participants
Interval 54.4 to 89.6
100.0 percentage of participants
Interval 5.0 to 100.0
52.0 percentage of participants
Interval 34.1 to 69.5

SECONDARY outcome

Timeframe: Up to approximately 5 years and 10 months

Population: Efficacy Analysis Set

DOR is defined as the time from the date of the earliest documented CR or PR (that is subsequently confirmed) to disease progression or death due to any cause, whichever occurs earlier, based on investigator assessment using RECIST v1.1. Only responders will be included in the assessment.

Outcome measures

Outcome measures
Measure
Dose Escalation: Pamiparib + Temozolomide (TMZ) 40 mg (Days 1-7)
Pamiparib 60 mg twice daily on Days 1 to 28 in combination with pulse dosing of TMZ 40 mg once daily on Days 1 to 7 within a 28-day cycle
Dose Escalation: Pamiparib + TMZ 60 mg (Days 1-7)
n=2 Participants
Pamiparib 60 mg twice daily on Days 1 to 28 in combination with pulse dosing of TMZ 60 mg once daily on Days 1 to 7 within a 28-day cycle
Dose Escalation: Pamiparib + TMZ 80 mg (Days 1-7)
n=2 Participants
Pamiparib 60 mg twice daily on Days 1 to 28 in combination with pulse dosing of TMZ 80 mg once daily on Days 1 to 7 within a 28-day cycle
Dose Escalation: Pamiparib + TMZ 100 mg (Days 1-7)
Pamiparib 60 mg twice daily on Days 1 to 28 in combination with pulse dosing of TMZ 100 mg once daily on Days 1 to 7 within a 28-day cycle
Dose Escalation: Pamiparib + TMZ 120 mg (Days 1-7)
Pamiparib 60 mg twice daily on Days 1 to 28 in combination with pulse dosing of TMZ 120 mg once daily on Days 1 to 7 within a 28-day cycle
Dose Escalation: Pamiparib + TMZ 40 mg (Days 1-14)
n=3 Participants
Pamiparib 60 mg twice daily on Days 1 to 28 in combination with pulse dosing of TMZ 40 mg once daily on Days 1 to 14 within a 28-day cycle
Dose Escalation: Pamiparib + TMZ 20 mg (Days 1-28)
Pamiparib 60 mg twice daily in combination with TMZ 20 mg once daily administered continuously on Days 1 to 28 within a 28-day cycle
Dose Escalation: Pamiparib + TMZ 40 mg (Days 1-28)
n=1 Participants
Pamiparib 60 mg twice daily in combination with TMZ 40 mg once daily administered continuously on Days 1 to 28 within a 28-day cycle
Dose Expansion: Gastric Cancer
Participants with gastric or gastroesophageal junction cancer received TMZ 60 mg once daily administered on Days 1 to 7 in combination with pamiparib 60 mg twice daily on Days 1 to 28 of each cycle
Dose Expansion: Ovarian Cancer
n=2 Participants
Participants with ovarian cancer, fallopian cancer, or primary peritoneal cancer received TMZ 60 mg once daily administered on Days 1 to 7 in combination with pamiparib 60 mg twice daily on Days 1 to 28 of each cycle
Dose Expansion: SCLC
n=3 Participants
Participants with Small Cell Lung Cancer (SCLC) received TMZ 60 mg once daily administered on Days 1 to 7 in combination with pamiparib 60 mg twice daily on Days 1 to 28 of each cycle
Dose Expansion: TNBC
n=1 Participants
Participants with triple negative breast cancer (TNBC) received TMZ 60 mg once daily administered on Days 1 to 7 in combination with pamiparib 60 mg twice daily on Days 1 to 28 of each cycle
Dose Expansion: Other HRD+ Cancers
n=2 Participants
Participants with non-small cell lung cancer (NSCLC), esophageal cancer, squamous head and neck cancer, or soft tissue sarcomas whose tumors are homologous recombination deficiency (HRD)+ received TMZ 60 mg once daily administered on Days 1 to 7 in combination with pamiparib 60 mg twice daily on Days 1 to 28 of each cycle
Duration of Response (DOR)
13.0 months
NA = Not estimable due to insufficient number of participants with events
6.4 months
Interval 5.5 to
NA = Not estimable due to insufficient number of participants with events
9.2 months
Interval 7.7 to
NA = Not estimable due to insufficient number of participants with events
3.7 months
NA = Not estimable due to insufficient number of participants with events
5.4 months
Interval 4.9 to
NA = Not estimable due to insufficient number of participants with events
3.8 months
Interval 3.2 to
NA = Not estimable due to insufficient number of participants with events
11.0 months
NA = Not estimable due to insufficient number of participants with events
NA months
Interval 7.4 to
NA = Not estimable due to insufficient number of participants with events

SECONDARY outcome

Timeframe: Up to approximately 5 years and 10 months)

Population: Efficacy Analysis Set

PFS is defined as the time (months) from the date of the first dose of combination treatment to disease progression or death due to any cause, whichever occurs first, based on investigator assessment using RECIST v1.1

Outcome measures

Outcome measures
Measure
Dose Escalation: Pamiparib + Temozolomide (TMZ) 40 mg (Days 1-7)
n=3 Participants
Pamiparib 60 mg twice daily on Days 1 to 28 in combination with pulse dosing of TMZ 40 mg once daily on Days 1 to 7 within a 28-day cycle
Dose Escalation: Pamiparib + TMZ 60 mg (Days 1-7)
n=12 Participants
Pamiparib 60 mg twice daily on Days 1 to 28 in combination with pulse dosing of TMZ 60 mg once daily on Days 1 to 7 within a 28-day cycle
Dose Escalation: Pamiparib + TMZ 80 mg (Days 1-7)
n=8 Participants
Pamiparib 60 mg twice daily on Days 1 to 28 in combination with pulse dosing of TMZ 80 mg once daily on Days 1 to 7 within a 28-day cycle
Dose Escalation: Pamiparib + TMZ 100 mg (Days 1-7)
n=2 Participants
Pamiparib 60 mg twice daily on Days 1 to 28 in combination with pulse dosing of TMZ 100 mg once daily on Days 1 to 7 within a 28-day cycle
Dose Escalation: Pamiparib + TMZ 120 mg (Days 1-7)
n=2 Participants
Pamiparib 60 mg twice daily on Days 1 to 28 in combination with pulse dosing of TMZ 120 mg once daily on Days 1 to 7 within a 28-day cycle
Dose Escalation: Pamiparib + TMZ 40 mg (Days 1-14)
n=14 Participants
Pamiparib 60 mg twice daily on Days 1 to 28 in combination with pulse dosing of TMZ 40 mg once daily on Days 1 to 14 within a 28-day cycle
Dose Escalation: Pamiparib + TMZ 20 mg (Days 1-28)
n=13 Participants
Pamiparib 60 mg twice daily in combination with TMZ 20 mg once daily administered continuously on Days 1 to 28 within a 28-day cycle
Dose Escalation: Pamiparib + TMZ 40 mg (Days 1-28)
n=4 Participants
Pamiparib 60 mg twice daily in combination with TMZ 40 mg once daily administered continuously on Days 1 to 28 within a 28-day cycle
Dose Expansion: Gastric Cancer
n=19 Participants
Participants with gastric or gastroesophageal junction cancer received TMZ 60 mg once daily administered on Days 1 to 7 in combination with pamiparib 60 mg twice daily on Days 1 to 28 of each cycle
Dose Expansion: Ovarian Cancer
n=4 Participants
Participants with ovarian cancer, fallopian cancer, or primary peritoneal cancer received TMZ 60 mg once daily administered on Days 1 to 7 in combination with pamiparib 60 mg twice daily on Days 1 to 28 of each cycle
Dose Expansion: SCLC
n=20 Participants
Participants with Small Cell Lung Cancer (SCLC) received TMZ 60 mg once daily administered on Days 1 to 7 in combination with pamiparib 60 mg twice daily on Days 1 to 28 of each cycle
Dose Expansion: TNBC
n=1 Participants
Participants with triple negative breast cancer (TNBC) received TMZ 60 mg once daily administered on Days 1 to 7 in combination with pamiparib 60 mg twice daily on Days 1 to 28 of each cycle
Dose Expansion: Other HRD+ Cancers
n=25 Participants
Participants with non-small cell lung cancer (NSCLC), esophageal cancer, squamous head and neck cancer, or soft tissue sarcomas whose tumors are homologous recombination deficiency (HRD)+ received TMZ 60 mg once daily administered on Days 1 to 7 in combination with pamiparib 60 mg twice daily on Days 1 to 28 of each cycle
Progression Free Survival (PFS)
2.0 months
Interval 1.2 to
NA = Not estimable due to insufficient number of participants with events
5.6 months
Interval 2.7 to 22.0
5.3 months
Interval 1.8 to 7.5
NA months
Interval 4.5 to
NA = Not estimable due to insufficient number of participants with events
NA months
Interval 1.8 to
NA = Not estimable due to insufficient number of participants with events
2.8 months
Interval 1.7 to 3.7
3.1 months
Interval 1.7 to 3.9
3.5 months
Interval 1.1 to
NA = Not estimable due to insufficient number of participants with events
1.9 months
Interval 1.7 to 3.3
6.4 months
Interval 2.6 to
NA = Not estimable due to insufficient number of participants with events
3.5 months
Interval 2.3 to 4.1
14.8 months
NA = Not estimable due to insufficient number of participants with events
2.6 months
Interval 1.9 to 3.6

SECONDARY outcome

Timeframe: Up to approximately 5 years and 10 months

Population: The Safety Analysis Set included all participants who received any dose of pamiparib and/or TMZ.

OS is defined as the time from the date of the first dose of combination treatment to death due to any cause.

Outcome measures

Outcome measures
Measure
Dose Escalation: Pamiparib + Temozolomide (TMZ) 40 mg (Days 1-7)
n=4 Participants
Pamiparib 60 mg twice daily on Days 1 to 28 in combination with pulse dosing of TMZ 40 mg once daily on Days 1 to 7 within a 28-day cycle
Dose Escalation: Pamiparib + TMZ 60 mg (Days 1-7)
n=13 Participants
Pamiparib 60 mg twice daily on Days 1 to 28 in combination with pulse dosing of TMZ 60 mg once daily on Days 1 to 7 within a 28-day cycle
Dose Escalation: Pamiparib + TMZ 80 mg (Days 1-7)
n=9 Participants
Pamiparib 60 mg twice daily on Days 1 to 28 in combination with pulse dosing of TMZ 80 mg once daily on Days 1 to 7 within a 28-day cycle
Dose Escalation: Pamiparib + TMZ 100 mg (Days 1-7)
n=3 Participants
Pamiparib 60 mg twice daily on Days 1 to 28 in combination with pulse dosing of TMZ 100 mg once daily on Days 1 to 7 within a 28-day cycle
Dose Escalation: Pamiparib + TMZ 120 mg (Days 1-7)
n=3 Participants
Pamiparib 60 mg twice daily on Days 1 to 28 in combination with pulse dosing of TMZ 120 mg once daily on Days 1 to 7 within a 28-day cycle
Dose Escalation: Pamiparib + TMZ 40 mg (Days 1-14)
n=14 Participants
Pamiparib 60 mg twice daily on Days 1 to 28 in combination with pulse dosing of TMZ 40 mg once daily on Days 1 to 14 within a 28-day cycle
Dose Escalation: Pamiparib + TMZ 20 mg (Days 1-28)
n=14 Participants
Pamiparib 60 mg twice daily in combination with TMZ 20 mg once daily administered continuously on Days 1 to 28 within a 28-day cycle
Dose Escalation: Pamiparib + TMZ 40 mg (Days 1-28)
n=6 Participants
Pamiparib 60 mg twice daily in combination with TMZ 40 mg once daily administered continuously on Days 1 to 28 within a 28-day cycle
Dose Expansion: Gastric Cancer
n=21 Participants
Participants with gastric or gastroesophageal junction cancer received TMZ 60 mg once daily administered on Days 1 to 7 in combination with pamiparib 60 mg twice daily on Days 1 to 28 of each cycle
Dose Expansion: Ovarian Cancer
n=4 Participants
Participants with ovarian cancer, fallopian cancer, or primary peritoneal cancer received TMZ 60 mg once daily administered on Days 1 to 7 in combination with pamiparib 60 mg twice daily on Days 1 to 28 of each cycle
Dose Expansion: SCLC
n=22 Participants
Participants with Small Cell Lung Cancer (SCLC) received TMZ 60 mg once daily administered on Days 1 to 7 in combination with pamiparib 60 mg twice daily on Days 1 to 28 of each cycle
Dose Expansion: TNBC
n=1 Participants
Participants with triple negative breast cancer (TNBC) received TMZ 60 mg once daily administered on Days 1 to 7 in combination with pamiparib 60 mg twice daily on Days 1 to 28 of each cycle
Dose Expansion: Other HRD+ Cancers
n=25 Participants
Participants with non-small cell lung cancer (NSCLC), esophageal cancer, squamous head and neck cancer, or soft tissue sarcomas whose tumors are homologous recombination deficiency (HRD)+ received TMZ 60 mg once daily administered on Days 1 to 7 in combination with pamiparib 60 mg twice daily on Days 1 to 28 of each cycle
Overall Survival (OS)
7.6 months
Interval 2.2 to
NA = Not estimable due to insufficient number of events
14.8 months
Interval 8.4 to
NA = Not estimable due to insufficient number of events
12.7 months
Interval 9.4 to
NA = Not estimable due to insufficient number of events
12.4 months
Interval 4.5 to
NA = Not estimable due to insufficient number of events
12.3 months
Interval 4.2 to
NA = Not estimable due to insufficient number of events
6.3 months
Interval 3.4 to 31.8
13.9 months
Interval 8.0 to
NA = Not estimable due to insufficient number of events
8.2 months
Interval 1.1 to 12.7
6.6 months
Interval 3.8 to 9.9
21.2 months
Interval 11.1 to
NA = Not estimable due to insufficient number of events
7.7 months
Interval 4.1 to 13.1
19.4 months
NA = Not estimable due to insufficient number of events
9.8 months
Interval 7.6 to 11.7

Adverse Events

Dose Escalation: Pamiparib + Temozolomide (TMZ) 40 mg (Days 1-7)

Serious events: 1 serious events
Other events: 4 other events
Deaths: 4 deaths

Dose Escalation: Pamiparib + TMZ 60 mg (Days 1-7)

Serious events: 4 serious events
Other events: 13 other events
Deaths: 8 deaths

Dose Escalation: Pamiparib + TMZ 80 mg (Days 1-7)

Serious events: 1 serious events
Other events: 9 other events
Deaths: 7 deaths

Dose Escalation: Pamiparib + TMZ 100 mg (Days 1-7)

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

Dose Escalation: Pamiparib + TMZ 120 mg (Days 1-7)

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

Dose Escalation: Pamiparib + TMZ 40 mg (Days 1-14)

Serious events: 5 serious events
Other events: 14 other events
Deaths: 10 deaths

Dose Escalation: Pamiparib + TMZ 20 mg (Days 1-28)

Serious events: 5 serious events
Other events: 14 other events
Deaths: 8 deaths

Dose Escalation: Pamiparib + TMZ 40 mg (Days 1-28)

Serious events: 0 serious events
Other events: 6 other events
Deaths: 6 deaths

Dose Expansion: Gastric Cancer

Serious events: 9 serious events
Other events: 20 other events
Deaths: 18 deaths

Dose Expansion: Ovarian Cancer

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

Dose Expansion: SCLC

Serious events: 9 serious events
Other events: 22 other events
Deaths: 19 deaths

Dose Expansion: TNBC

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

Dose Expansion: Other HRD+ Cancers

Serious events: 9 serious events
Other events: 24 other events
Deaths: 19 deaths

Serious adverse events

Serious adverse events
Measure
Dose Escalation: Pamiparib + Temozolomide (TMZ) 40 mg (Days 1-7)
n=4 participants at risk
Pamiparib 60 mg twice daily on Days 1 to 28 in combination with pulse dosing of TMZ 40 mg once daily on Days 1 to 7 within a 28-day cycle
Dose Escalation: Pamiparib + TMZ 60 mg (Days 1-7)
n=13 participants at risk
Pamiparib 60 mg twice daily on Days 1 to 28 in combination with pulse dosing of TMZ 60 mg once daily on Days 1 to 7 within a 28-day cycle
Dose Escalation: Pamiparib + TMZ 80 mg (Days 1-7)
n=9 participants at risk
Pamiparib 60 mg twice daily on Days 1 to 28 in combination with pulse dosing of TMZ 80 mg once daily on Days 1 to 7 within a 28-day cycle
Dose Escalation: Pamiparib + TMZ 100 mg (Days 1-7)
n=3 participants at risk
Pamiparib 60 mg twice daily on Days 1 to 28 in combination with pulse dosing of TMZ 100 mg once daily on Days 1 to 7 within a 28-day cycle
Dose Escalation: Pamiparib + TMZ 120 mg (Days 1-7)
n=3 participants at risk
Pamiparib 60 mg twice daily on Days 1 to 28 in combination with pulse dosing of TMZ 120 mg once daily on Days 1 to 7 within a 28-day cycle
Dose Escalation: Pamiparib + TMZ 40 mg (Days 1-14)
n=14 participants at risk
Pamiparib 60 mg twice daily on Days 1 to 28 in combination with pulse dosing of TMZ 40 mg once daily on Days 1 to 14 within a 28-day cycle
Dose Escalation: Pamiparib + TMZ 20 mg (Days 1-28)
n=14 participants at risk
Pamiparib 60 mg twice daily in combination with TMZ 20 mg once daily administered continuously on Days 1 to 28 within a 28-day cycle
Dose Escalation: Pamiparib + TMZ 40 mg (Days 1-28)
n=6 participants at risk
Pamiparib 60 mg twice daily in combination with TMZ 40 mg once daily administered continuously on Days 1 to 28 within a 28-day cycle
Dose Expansion: Gastric Cancer
n=21 participants at risk
Participants with gastric or gastroesophageal junction cancer received TMZ 60 mg once daily administered on Days 1 to 7 in combination with pamiparib 60 mg twice daily on Days 1 to 28 of each cycle
Dose Expansion: Ovarian Cancer
n=4 participants at risk
Participants with ovarian cancer, fallopian cancer, or primary peritoneal cancer received TMZ 60 mg once daily administered on Days 1 to 7 in combination with pamiparib 60 mg twice daily on Days 1 to 28 of each cycle
Dose Expansion: SCLC
n=22 participants at risk
Participants with Small Cell Lung Cancer (SCLC) received TMZ 60 mg once daily administered on Days 1 to 7 in combination with pamiparib 60 mg twice daily on Days 1 to 28 of each cycle
Dose Expansion: TNBC
n=1 participants at risk
Participants with triple negative breast cancer (TNBC) received TMZ 60 mg once daily administered on Days 1 to 7 in combination with pamiparib 60 mg twice daily on Days 1 to 28 of each cycle
Dose Expansion: Other HRD+ Cancers
n=25 participants at risk
Participants with non-small cell lung cancer (NSCLC), esophageal cancer, squamous head and neck cancer, or soft tissue sarcomas whose tumors are homologous recombination deficiency (HRD)+ received TMZ 60 mg once daily administered on Days 1 to 7 in combination with pamiparib 60 mg twice daily on Days 1 to 28 of each cycle
Blood and lymphatic system disorders
Anaemia
0.00%
0/4 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/13 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/9 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/3 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/3 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/14 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/14 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/6 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
9.5%
2/21 • Number of events 2 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
25.0%
1/4 • Number of events 1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/22 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
4.0%
1/25 • Number of events 1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
Blood and lymphatic system disorders
Febrile neutropenia
0.00%
0/4 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/13 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/9 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/3 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/3 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
7.1%
1/14 • Number of events 1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/14 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/6 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/21 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/4 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/22 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/25 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
Blood and lymphatic system disorders
Neutropenia
0.00%
0/4 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/13 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/9 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/3 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/3 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/14 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
7.1%
1/14 • Number of events 1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/6 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
4.8%
1/21 • Number of events 1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
25.0%
1/4 • Number of events 1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
4.5%
1/22 • Number of events 1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/25 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
Blood and lymphatic system disorders
Pancytopenia
0.00%
0/4 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/13 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/9 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/3 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/3 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/14 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/14 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/6 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/21 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/4 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
4.5%
1/22 • Number of events 1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
4.0%
1/25 • Number of events 1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
Blood and lymphatic system disorders
Thrombocytopenia
0.00%
0/4 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/13 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/9 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/3 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/3 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/14 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/14 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/6 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
4.8%
1/21 • Number of events 1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/4 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
4.5%
1/22 • Number of events 1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
4.0%
1/25 • Number of events 1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
Congenital, familial and genetic disorders
Right-to-left cardiac shunt
0.00%
0/4 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/13 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/9 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/3 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/3 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/14 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
7.1%
1/14 • Number of events 1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/6 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/21 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/4 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/22 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/25 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
Gastrointestinal disorders
Abdominal pain
0.00%
0/4 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
15.4%
2/13 • Number of events 2 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/9 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/3 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
33.3%
1/3 • Number of events 1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/14 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/14 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/6 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
4.8%
1/21 • Number of events 1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
25.0%
1/4 • Number of events 1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
4.5%
1/22 • Number of events 1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/25 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
Gastrointestinal disorders
Ascites
0.00%
0/4 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/13 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/9 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/3 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/3 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/14 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/14 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/6 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/21 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/4 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/22 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
4.0%
1/25 • Number of events 1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
Gastrointestinal disorders
Constipation
0.00%
0/4 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/13 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/9 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/3 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/3 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/14 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/14 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/6 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/21 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/4 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
4.5%
1/22 • Number of events 1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/25 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
Gastrointestinal disorders
Dysphagia
0.00%
0/4 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/13 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/9 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/3 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/3 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/14 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/14 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/6 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
4.8%
1/21 • Number of events 1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/4 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/22 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/25 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
Gastrointestinal disorders
Gastric perforation
0.00%
0/4 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/13 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/9 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/3 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/3 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/14 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/14 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/6 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/21 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/4 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/22 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
4.0%
1/25 • Number of events 1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
Gastrointestinal disorders
Gastrointestinal obstruction
0.00%
0/4 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/13 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/9 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/3 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/3 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
7.1%
1/14 • Number of events 1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/14 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/6 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/21 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/4 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/22 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/25 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
Gastrointestinal disorders
Large intestine perforation
0.00%
0/4 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/13 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/9 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/3 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/3 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/14 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/14 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/6 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/21 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
25.0%
1/4 • Number of events 1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/22 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/25 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
Gastrointestinal disorders
Oesophagitis
0.00%
0/4 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/13 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/9 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
33.3%
1/3 • Number of events 1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/3 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/14 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/14 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/6 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/21 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/4 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/22 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/25 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
Gastrointestinal disorders
Upper gastrointestinal haemorrhage
0.00%
0/4 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/13 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/9 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/3 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/3 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/14 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/14 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/6 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
4.8%
1/21 • Number of events 1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/4 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/22 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/25 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
General disorders
Asthenia
0.00%
0/4 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/13 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/9 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/3 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/3 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/14 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/14 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/6 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
4.8%
1/21 • Number of events 1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/4 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
4.5%
1/22 • Number of events 1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/25 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
General disorders
Fatigue
0.00%
0/4 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/13 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/9 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/3 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/3 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/14 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/14 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/6 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
9.5%
2/21 • Number of events 2 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/4 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/22 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/25 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
General disorders
Pyrexia
0.00%
0/4 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/13 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/9 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/3 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/3 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/14 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/14 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/6 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/21 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/4 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/22 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
4.0%
1/25 • Number of events 1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
Hepatobiliary disorders
Hyperbilirubinaemia
0.00%
0/4 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/13 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/9 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/3 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/3 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/14 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/14 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/6 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
4.8%
1/21 • Number of events 1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/4 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/22 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/25 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
Infections and infestations
Abdominal abscess
25.0%
1/4 • Number of events 1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/13 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/9 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/3 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/3 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/14 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/14 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/6 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/21 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/4 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/22 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/25 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
Infections and infestations
Appendicitis
0.00%
0/4 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/13 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/9 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/3 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/3 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/14 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/14 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/6 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/21 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/4 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/22 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
4.0%
1/25 • Number of events 1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
Infections and infestations
Biliary sepsis
0.00%
0/4 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/13 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/9 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/3 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/3 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
7.1%
1/14 • Number of events 1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/14 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/6 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/21 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/4 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/22 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/25 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
Infections and infestations
COVID-19
0.00%
0/4 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/13 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/9 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/3 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/3 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/14 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/14 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/6 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/21 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/4 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/22 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
4.0%
1/25 • Number of events 1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
Infections and infestations
Endocarditis
0.00%
0/4 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/13 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/9 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/3 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/3 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/14 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/14 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/6 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
4.8%
1/21 • Number of events 1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/4 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/22 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/25 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
Infections and infestations
Groin abscess
0.00%
0/4 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/13 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/9 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/3 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/3 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
7.1%
1/14 • Number of events 1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/14 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/6 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/21 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/4 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/22 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/25 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
Infections and infestations
Infectious pleural effusion
0.00%
0/4 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/13 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/9 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/3 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/3 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
7.1%
1/14 • Number of events 1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/14 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/6 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/21 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/4 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/22 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/25 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
Infections and infestations
Influenza
0.00%
0/4 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/13 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/9 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/3 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/3 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/14 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
7.1%
1/14 • Number of events 1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/6 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/21 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/4 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/22 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/25 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
Infections and infestations
Pneumocystis jirovecii infection
0.00%
0/4 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/13 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/9 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/3 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/3 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/14 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/14 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/6 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/21 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/4 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
4.5%
1/22 • Number of events 1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/25 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
Infections and infestations
Pneumonia
0.00%
0/4 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/13 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/9 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/3 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/3 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
7.1%
1/14 • Number of events 1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
7.1%
1/14 • Number of events 1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/6 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/21 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/4 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
4.5%
1/22 • Number of events 1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/25 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
Infections and infestations
Respiratory tract infection
0.00%
0/4 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/13 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/9 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/3 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/3 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/14 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/14 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/6 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/21 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/4 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
9.1%
2/22 • Number of events 2 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/25 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
Infections and infestations
Sepsis
0.00%
0/4 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/13 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/9 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/3 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/3 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
7.1%
1/14 • Number of events 1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/14 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/6 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/21 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/4 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/22 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/25 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
Infections and infestations
Urinary tract infection
0.00%
0/4 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/13 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/9 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/3 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
33.3%
1/3 • Number of events 1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/14 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/14 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/6 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
4.8%
1/21 • Number of events 1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/4 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/22 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/25 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
Injury, poisoning and procedural complications
Fall
0.00%
0/4 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/13 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/9 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/3 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/3 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/14 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
7.1%
1/14 • Number of events 1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/6 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/21 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/4 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/22 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
4.0%
1/25 • Number of events 1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
Injury, poisoning and procedural complications
Spinal compression fracture
0.00%
0/4 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/13 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/9 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/3 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
33.3%
1/3 • Number of events 1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/14 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/14 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/6 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/21 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/4 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/22 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/25 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
Injury, poisoning and procedural complications
Stoma site haemorrhage
0.00%
0/4 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/13 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/9 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/3 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/3 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
7.1%
1/14 • Number of events 1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/14 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/6 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/21 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/4 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/22 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/25 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
Investigations
Alanine aminotransferase increased
0.00%
0/4 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/13 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/9 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/3 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/3 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/14 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/14 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/6 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/21 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
25.0%
1/4 • Number of events 1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/22 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/25 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
Investigations
Aspartate aminotransferase increased
0.00%
0/4 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/13 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/9 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/3 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/3 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/14 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/14 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/6 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/21 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
25.0%
1/4 • Number of events 1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/22 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/25 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
Metabolism and nutrition disorders
Hypoglycaemia
0.00%
0/4 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/13 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
11.1%
1/9 • Number of events 1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/3 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/3 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/14 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/14 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/6 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/21 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/4 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/22 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/25 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
Musculoskeletal and connective tissue disorders
Bone pain
0.00%
0/4 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/13 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/9 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/3 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/3 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/14 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/14 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/6 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
4.8%
1/21 • Number of events 1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/4 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/22 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/25 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cancer pain
0.00%
0/4 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/13 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/9 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/3 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/3 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/14 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/14 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/6 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/21 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/4 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/22 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
4.0%
1/25 • Number of events 1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour pain
0.00%
0/4 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/13 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/9 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/3 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/3 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/14 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/14 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/6 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
4.8%
1/21 • Number of events 1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/4 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/22 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/25 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
Nervous system disorders
Ataxia
0.00%
0/4 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/13 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/9 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/3 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/3 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/14 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/14 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/6 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/21 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/4 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
4.5%
1/22 • Number of events 1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/25 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
Nervous system disorders
Cerebrovascular accident
0.00%
0/4 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/13 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/9 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/3 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/3 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/14 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/14 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/6 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
4.8%
1/21 • Number of events 2 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/4 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/22 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/25 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
Nervous system disorders
Peripheral sensory neuropathy
0.00%
0/4 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
7.7%
1/13 • Number of events 1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/9 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/3 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/3 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/14 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/14 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/6 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/21 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/4 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/22 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/25 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
Nervous system disorders
Precerebral artery embolism
0.00%
0/4 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/13 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/9 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/3 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/3 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/14 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/14 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/6 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
4.8%
1/21 • Number of events 1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/4 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/22 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/25 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
Renal and urinary disorders
Acute kidney injury
0.00%
0/4 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/13 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/9 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/3 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
33.3%
1/3 • Number of events 1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/14 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/14 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/6 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/21 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/4 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/22 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/25 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
Renal and urinary disorders
Haematuria
0.00%
0/4 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/13 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/9 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/3 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
33.3%
1/3 • Number of events 1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/14 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/14 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/6 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/21 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/4 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/22 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/25 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
Renal and urinary disorders
Hydronephrosis
0.00%
0/4 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/13 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/9 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/3 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
33.3%
1/3 • Number of events 1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/14 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/14 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/6 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/21 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/4 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/22 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/25 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
Respiratory, thoracic and mediastinal disorders
Dyspnoea
0.00%
0/4 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/13 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/9 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/3 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/3 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/14 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
7.1%
1/14 • Number of events 1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/6 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/21 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/4 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/22 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
4.0%
1/25 • Number of events 1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
Respiratory, thoracic and mediastinal disorders
Pleural effusion
0.00%
0/4 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/13 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/9 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
33.3%
1/3 • Number of events 1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/3 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/14 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/14 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/6 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/21 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/4 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/22 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/25 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
Respiratory, thoracic and mediastinal disorders
Pneumonitis
0.00%
0/4 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/13 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/9 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/3 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/3 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/14 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/14 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/6 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/21 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/4 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
4.5%
1/22 • Number of events 1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/25 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
Respiratory, thoracic and mediastinal disorders
Pneumothorax
0.00%
0/4 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/13 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/9 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
33.3%
1/3 • Number of events 1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/3 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/14 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/14 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/6 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/21 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/4 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/22 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/25 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
0.00%
0/4 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
7.7%
1/13 • Number of events 1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/9 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/3 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/3 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/14 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/14 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/6 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/21 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/4 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/22 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/25 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
Respiratory, thoracic and mediastinal disorders
Respiratory failure
0.00%
0/4 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/13 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/9 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/3 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/3 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/14 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/14 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/6 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/21 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/4 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
4.5%
1/22 • Number of events 1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/25 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
Vascular disorders
Superior vena cava syndrome
0.00%
0/4 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/13 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/9 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/3 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/3 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/14 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/14 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/6 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/21 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/4 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/22 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
4.0%
1/25 • Number of events 1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.

Other adverse events

Other adverse events
Measure
Dose Escalation: Pamiparib + Temozolomide (TMZ) 40 mg (Days 1-7)
n=4 participants at risk
Pamiparib 60 mg twice daily on Days 1 to 28 in combination with pulse dosing of TMZ 40 mg once daily on Days 1 to 7 within a 28-day cycle
Dose Escalation: Pamiparib + TMZ 60 mg (Days 1-7)
n=13 participants at risk
Pamiparib 60 mg twice daily on Days 1 to 28 in combination with pulse dosing of TMZ 60 mg once daily on Days 1 to 7 within a 28-day cycle
Dose Escalation: Pamiparib + TMZ 80 mg (Days 1-7)
n=9 participants at risk
Pamiparib 60 mg twice daily on Days 1 to 28 in combination with pulse dosing of TMZ 80 mg once daily on Days 1 to 7 within a 28-day cycle
Dose Escalation: Pamiparib + TMZ 100 mg (Days 1-7)
n=3 participants at risk
Pamiparib 60 mg twice daily on Days 1 to 28 in combination with pulse dosing of TMZ 100 mg once daily on Days 1 to 7 within a 28-day cycle
Dose Escalation: Pamiparib + TMZ 120 mg (Days 1-7)
n=3 participants at risk
Pamiparib 60 mg twice daily on Days 1 to 28 in combination with pulse dosing of TMZ 120 mg once daily on Days 1 to 7 within a 28-day cycle
Dose Escalation: Pamiparib + TMZ 40 mg (Days 1-14)
n=14 participants at risk
Pamiparib 60 mg twice daily on Days 1 to 28 in combination with pulse dosing of TMZ 40 mg once daily on Days 1 to 14 within a 28-day cycle
Dose Escalation: Pamiparib + TMZ 20 mg (Days 1-28)
n=14 participants at risk
Pamiparib 60 mg twice daily in combination with TMZ 20 mg once daily administered continuously on Days 1 to 28 within a 28-day cycle
Dose Escalation: Pamiparib + TMZ 40 mg (Days 1-28)
n=6 participants at risk
Pamiparib 60 mg twice daily in combination with TMZ 40 mg once daily administered continuously on Days 1 to 28 within a 28-day cycle
Dose Expansion: Gastric Cancer
n=21 participants at risk
Participants with gastric or gastroesophageal junction cancer received TMZ 60 mg once daily administered on Days 1 to 7 in combination with pamiparib 60 mg twice daily on Days 1 to 28 of each cycle
Dose Expansion: Ovarian Cancer
n=4 participants at risk
Participants with ovarian cancer, fallopian cancer, or primary peritoneal cancer received TMZ 60 mg once daily administered on Days 1 to 7 in combination with pamiparib 60 mg twice daily on Days 1 to 28 of each cycle
Dose Expansion: SCLC
n=22 participants at risk
Participants with Small Cell Lung Cancer (SCLC) received TMZ 60 mg once daily administered on Days 1 to 7 in combination with pamiparib 60 mg twice daily on Days 1 to 28 of each cycle
Dose Expansion: TNBC
n=1 participants at risk
Participants with triple negative breast cancer (TNBC) received TMZ 60 mg once daily administered on Days 1 to 7 in combination with pamiparib 60 mg twice daily on Days 1 to 28 of each cycle
Dose Expansion: Other HRD+ Cancers
n=25 participants at risk
Participants with non-small cell lung cancer (NSCLC), esophageal cancer, squamous head and neck cancer, or soft tissue sarcomas whose tumors are homologous recombination deficiency (HRD)+ received TMZ 60 mg once daily administered on Days 1 to 7 in combination with pamiparib 60 mg twice daily on Days 1 to 28 of each cycle
Hepatobiliary disorders
Hepatomegaly
0.00%
0/4 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/13 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/9 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/3 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/3 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/14 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/14 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
16.7%
1/6 • Number of events 1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/21 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/4 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/22 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/25 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
Hepatobiliary disorders
Hyperbilirubinaemia
0.00%
0/4 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/13 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/9 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/3 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/3 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/14 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/14 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/6 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
4.8%
1/21 • Number of events 1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/4 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/22 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/25 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
Blood and lymphatic system disorders
Anaemia
0.00%
0/4 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
61.5%
8/13 • Number of events 11 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
55.6%
5/9 • Number of events 8 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
66.7%
2/3 • Number of events 8 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
100.0%
3/3 • Number of events 4 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
71.4%
10/14 • Number of events 15 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
42.9%
6/14 • Number of events 10 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
50.0%
3/6 • Number of events 4 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
57.1%
12/21 • Number of events 15 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
50.0%
2/4 • Number of events 4 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
59.1%
13/22 • Number of events 18 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
100.0%
1/1 • Number of events 4 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
64.0%
16/25 • Number of events 25 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
Blood and lymphatic system disorders
Leukopenia
0.00%
0/4 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/13 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/9 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/3 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
33.3%
1/3 • Number of events 1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/14 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
7.1%
1/14 • Number of events 1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
16.7%
1/6 • Number of events 1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/21 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/4 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/22 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/25 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
Blood and lymphatic system disorders
Lymphadenopathy
0.00%
0/4 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/13 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/9 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/3 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/3 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/14 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/14 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/6 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/21 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/4 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/22 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
100.0%
1/1 • Number of events 1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/25 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
Blood and lymphatic system disorders
Lymphopenia
25.0%
1/4 • Number of events 2 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/13 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/9 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/3 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
33.3%
1/3 • Number of events 1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/14 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/14 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/6 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/21 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/4 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
4.5%
1/22 • Number of events 1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/25 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
Blood and lymphatic system disorders
Neutropenia
25.0%
1/4 • Number of events 1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
30.8%
4/13 • Number of events 8 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
33.3%
3/9 • Number of events 5 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
66.7%
2/3 • Number of events 8 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
100.0%
3/3 • Number of events 4 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
35.7%
5/14 • Number of events 16 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
21.4%
3/14 • Number of events 4 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
16.7%
1/6 • Number of events 1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
23.8%
5/21 • Number of events 6 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
75.0%
3/4 • Number of events 3 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
27.3%
6/22 • Number of events 7 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
100.0%
1/1 • Number of events 5 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
20.0%
5/25 • Number of events 6 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
Blood and lymphatic system disorders
Thrombocytopenia
25.0%
1/4 • Number of events 3 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
38.5%
5/13 • Number of events 10 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
44.4%
4/9 • Number of events 5 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
33.3%
1/3 • Number of events 6 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
100.0%
3/3 • Number of events 9 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
50.0%
7/14 • Number of events 15 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
7.1%
1/14 • Number of events 1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
33.3%
2/6 • Number of events 2 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
28.6%
6/21 • Number of events 6 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
50.0%
2/4 • Number of events 5 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
27.3%
6/22 • Number of events 12 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
12.0%
3/25 • Number of events 4 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
Blood and lymphatic system disorders
Thrombocytosis
0.00%
0/4 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/13 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/9 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/3 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/3 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/14 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/14 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/6 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/21 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/4 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/22 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
4.0%
1/25 • Number of events 1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
Cardiac disorders
Aortic valve disease
0.00%
0/4 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/13 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/9 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/3 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
33.3%
1/3 • Number of events 1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/14 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/14 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/6 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/21 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/4 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/22 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/25 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
Cardiac disorders
Palpitations
0.00%
0/4 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/13 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/9 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/3 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/3 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/14 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
7.1%
1/14 • Number of events 1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/6 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/21 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/4 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/22 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/25 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
Cardiac disorders
Sinus bradycardia
0.00%
0/4 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/13 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/9 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/3 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
33.3%
1/3 • Number of events 1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/14 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/14 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/6 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/21 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/4 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/22 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/25 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
Cardiac disorders
Tachycardia
0.00%
0/4 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
7.7%
1/13 • Number of events 1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/9 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/3 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/3 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
7.1%
1/14 • Number of events 1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/14 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/6 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/21 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/4 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/22 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/25 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
Ear and labyrinth disorders
Deafness unilateral
0.00%
0/4 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/13 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/9 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/3 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/3 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/14 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/14 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/6 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/21 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/4 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
4.5%
1/22 • Number of events 1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/25 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
Ear and labyrinth disorders
Ear pain
0.00%
0/4 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/13 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/9 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
33.3%
1/3 • Number of events 1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/3 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
7.1%
1/14 • Number of events 1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/14 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/6 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/21 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/4 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/22 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/25 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
Ear and labyrinth disorders
Vertigo
0.00%
0/4 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/13 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/9 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/3 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/3 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/14 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
7.1%
1/14 • Number of events 2 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/6 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/21 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/4 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/22 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/25 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
Endocrine disorders
Adrenal insufficiency
0.00%
0/4 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/13 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/9 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/3 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/3 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
7.1%
1/14 • Number of events 1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/14 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/6 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/21 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/4 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/22 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/25 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
Eye disorders
Cataract
0.00%
0/4 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/13 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/9 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/3 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/3 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
7.1%
1/14 • Number of events 1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
7.1%
1/14 • Number of events 1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/6 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/21 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/4 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/22 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/25 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
Eye disorders
Glaucoma
0.00%
0/4 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/13 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/9 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/3 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/3 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
7.1%
1/14 • Number of events 1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/14 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/6 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/21 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/4 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/22 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/25 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
Eye disorders
Iridocyclitis
0.00%
0/4 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/13 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/9 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/3 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/3 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/14 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/14 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/6 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/21 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/4 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
4.5%
1/22 • Number of events 1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/25 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
Eye disorders
Ocular hyperaemia
0.00%
0/4 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/13 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/9 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/3 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/3 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/14 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/14 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/6 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/21 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/4 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
4.5%
1/22 • Number of events 1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/25 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
Eye disorders
Photophobia
0.00%
0/4 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/13 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/9 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/3 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/3 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/14 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/14 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/6 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/21 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
25.0%
1/4 • Number of events 1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/22 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/25 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
Eye disorders
Vision blurred
25.0%
1/4 • Number of events 1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/13 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/9 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/3 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/3 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
7.1%
1/14 • Number of events 1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/14 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/6 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/21 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/4 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/22 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/25 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
Eye disorders
Vitreous floaters
0.00%
0/4 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
7.7%
1/13 • Number of events 1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/9 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/3 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/3 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
7.1%
1/14 • Number of events 1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/14 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/6 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/21 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/4 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/22 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/25 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
Gastrointestinal disorders
Abdominal discomfort
0.00%
0/4 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/13 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/9 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/3 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/3 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/14 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/14 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/6 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
14.3%
3/21 • Number of events 3 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/4 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/22 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/25 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
Gastrointestinal disorders
Abdominal distension
0.00%
0/4 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/13 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/9 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/3 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/3 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/14 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/14 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/6 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
4.8%
1/21 • Number of events 1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/4 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
4.5%
1/22 • Number of events 1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/25 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
Gastrointestinal disorders
Abdominal pain
0.00%
0/4 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
15.4%
2/13 • Number of events 2 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
22.2%
2/9 • Number of events 2 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/3 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
33.3%
1/3 • Number of events 1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
14.3%
2/14 • Number of events 2 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
7.1%
1/14 • Number of events 1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
16.7%
1/6 • Number of events 1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
14.3%
3/21 • Number of events 3 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
25.0%
1/4 • Number of events 1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
9.1%
2/22 • Number of events 2 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
100.0%
1/1 • Number of events 1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
12.0%
3/25 • Number of events 3 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
Gastrointestinal disorders
Abdominal pain lower
0.00%
0/4 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
7.7%
1/13 • Number of events 1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/9 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/3 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/3 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/14 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/14 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/6 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/21 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/4 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/22 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/25 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
Gastrointestinal disorders
Abdominal pain upper
0.00%
0/4 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
7.7%
1/13 • Number of events 1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/9 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/3 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/3 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/14 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/14 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
33.3%
2/6 • Number of events 2 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
4.8%
1/21 • Number of events 1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/4 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/22 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
8.0%
2/25 • Number of events 2 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
Gastrointestinal disorders
Anal inflammation
0.00%
0/4 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/13 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/9 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/3 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/3 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/14 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/14 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/6 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/21 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/4 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
4.5%
1/22 • Number of events 1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/25 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
Gastrointestinal disorders
Anorectal discomfort
0.00%
0/4 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/13 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/9 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/3 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/3 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/14 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/14 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/6 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/21 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/4 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
4.5%
1/22 • Number of events 1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/25 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
Gastrointestinal disorders
Ascites
0.00%
0/4 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/13 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/9 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/3 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/3 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
7.1%
1/14 • Number of events 1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/14 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/6 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
4.8%
1/21 • Number of events 1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/4 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/22 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/25 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
Gastrointestinal disorders
Cheilitis
0.00%
0/4 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/13 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/9 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/3 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
33.3%
1/3 • Number of events 1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/14 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/14 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/6 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/21 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/4 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/22 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/25 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
Gastrointestinal disorders
Constipation
0.00%
0/4 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
7.7%
1/13 • Number of events 2 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/9 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/3 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/3 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
7.1%
1/14 • Number of events 1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
42.9%
6/14 • Number of events 6 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
16.7%
1/6 • Number of events 1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
23.8%
5/21 • Number of events 6 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
50.0%
2/4 • Number of events 2 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
27.3%
6/22 • Number of events 6 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
16.0%
4/25 • Number of events 8 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
Gastrointestinal disorders
Diarrhoea
0.00%
0/4 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
23.1%
3/13 • Number of events 5 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
33.3%
3/9 • Number of events 4 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
33.3%
1/3 • Number of events 1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
33.3%
1/3 • Number of events 1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
28.6%
4/14 • Number of events 4 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
21.4%
3/14 • Number of events 3 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
33.3%
2/6 • Number of events 2 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
23.8%
5/21 • Number of events 9 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
50.0%
2/4 • Number of events 4 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
13.6%
3/22 • Number of events 6 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
100.0%
1/1 • Number of events 1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
12.0%
3/25 • Number of events 4 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
Gastrointestinal disorders
Dry mouth
0.00%
0/4 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/13 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/9 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/3 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/3 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/14 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/14 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/6 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/21 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/4 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
13.6%
3/22 • Number of events 4 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
4.0%
1/25 • Number of events 1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
Gastrointestinal disorders
Dyspepsia
0.00%
0/4 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
7.7%
1/13 • Number of events 1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
11.1%
1/9 • Number of events 1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/3 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/3 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
7.1%
1/14 • Number of events 1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
7.1%
1/14 • Number of events 1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/6 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
4.8%
1/21 • Number of events 1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/4 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
4.5%
1/22 • Number of events 1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
4.0%
1/25 • Number of events 1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
Gastrointestinal disorders
Dysphagia
0.00%
0/4 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/13 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/9 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/3 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/3 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/14 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/14 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/6 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
9.5%
2/21 • Number of events 2 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/4 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/22 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/25 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
Gastrointestinal disorders
Eructation
0.00%
0/4 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/13 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/9 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/3 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/3 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/14 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/14 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/6 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/21 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/4 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
4.5%
1/22 • Number of events 1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/25 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
Gastrointestinal disorders
Flatulence
0.00%
0/4 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/13 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/9 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/3 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/3 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
7.1%
1/14 • Number of events 1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/14 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/6 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
9.5%
2/21 • Number of events 2 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
25.0%
1/4 • Number of events 1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/22 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/25 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
Gastrointestinal disorders
Gastritis
0.00%
0/4 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/13 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/9 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/3 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/3 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/14 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/14 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/6 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/21 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
25.0%
1/4 • Number of events 1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/22 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/25 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
Gastrointestinal disorders
Gastrointestinal haemorrhage
0.00%
0/4 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/13 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/9 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/3 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/3 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/14 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/14 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/6 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
4.8%
1/21 • Number of events 1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/4 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/22 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/25 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
Gastrointestinal disorders
Gastrooesophageal reflux disease
25.0%
1/4 • Number of events 1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/13 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
11.1%
1/9 • Number of events 1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/3 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/3 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
7.1%
1/14 • Number of events 1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/14 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/6 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
4.8%
1/21 • Number of events 1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/4 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
4.5%
1/22 • Number of events 1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/25 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
Gastrointestinal disorders
Gingival bleeding
0.00%
0/4 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/13 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/9 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/3 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/3 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/14 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/14 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/6 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/21 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/4 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
4.5%
1/22 • Number of events 1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/25 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
Gastrointestinal disorders
Haematochezia
0.00%
0/4 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/13 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/9 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/3 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/3 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/14 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/14 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/6 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/21 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/4 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
4.5%
1/22 • Number of events 1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/25 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
Gastrointestinal disorders
Haemorrhoidal haemorrhage
0.00%
0/4 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/13 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/9 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/3 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/3 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/14 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/14 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/6 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/21 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
25.0%
1/4 • Number of events 2 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/22 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/25 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
Gastrointestinal disorders
Hypoaesthesia oral
0.00%
0/4 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
7.7%
1/13 • Number of events 1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/9 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/3 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/3 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/14 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/14 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/6 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/21 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/4 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/22 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/25 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
Gastrointestinal disorders
Nausea
75.0%
3/4 • Number of events 3 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
69.2%
9/13 • Number of events 12 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
55.6%
5/9 • Number of events 5 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
66.7%
2/3 • Number of events 2 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
66.7%
2/3 • Number of events 2 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
35.7%
5/14 • Number of events 6 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
42.9%
6/14 • Number of events 8 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
66.7%
4/6 • Number of events 4 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
57.1%
12/21 • Number of events 14 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
100.0%
4/4 • Number of events 4 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
54.5%
12/22 • Number of events 20 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
100.0%
1/1 • Number of events 1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
28.0%
7/25 • Number of events 10 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
Gastrointestinal disorders
Odynophagia
0.00%
0/4 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/13 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/9 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/3 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/3 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/14 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/14 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/6 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/21 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/4 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
9.1%
2/22 • Number of events 2 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/25 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
Gastrointestinal disorders
Oesophageal pain
0.00%
0/4 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/13 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/9 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
33.3%
1/3 • Number of events 1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/3 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/14 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/14 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/6 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/21 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/4 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/22 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/25 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
Gastrointestinal disorders
Oesophagitis
0.00%
0/4 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/13 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/9 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/3 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/3 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/14 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/14 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/6 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
4.8%
1/21 • Number of events 1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/4 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/22 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/25 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
Gastrointestinal disorders
Oral pain
0.00%
0/4 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/13 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/9 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/3 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/3 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/14 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/14 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/6 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/21 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/4 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/22 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
4.0%
1/25 • Number of events 1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
Gastrointestinal disorders
Regurgitation
0.00%
0/4 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/13 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/9 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/3 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/3 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/14 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/14 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/6 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
4.8%
1/21 • Number of events 1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/4 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/22 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/25 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
Gastrointestinal disorders
Saliva altered
0.00%
0/4 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/13 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/9 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/3 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/3 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/14 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/14 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/6 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/21 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/4 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/22 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
4.0%
1/25 • Number of events 1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
Gastrointestinal disorders
Salivary hypersecretion
0.00%
0/4 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/13 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/9 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/3 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/3 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
7.1%
1/14 • Number of events 1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/14 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/6 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
4.8%
1/21 • Number of events 1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/4 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/22 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/25 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
Gastrointestinal disorders
Small intestinal obstruction
25.0%
1/4 • Number of events 1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/13 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/9 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/3 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/3 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/14 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/14 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/6 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/21 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/4 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/22 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/25 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
Gastrointestinal disorders
Small intestinal perforation
25.0%
1/4 • Number of events 1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/13 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/9 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/3 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/3 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/14 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/14 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/6 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/21 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/4 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/22 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/25 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
Gastrointestinal disorders
Stomatitis
0.00%
0/4 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
7.7%
1/13 • Number of events 1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/9 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/3 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/3 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
7.1%
1/14 • Number of events 1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/14 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/6 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/21 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
50.0%
2/4 • Number of events 2 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
13.6%
3/22 • Number of events 3 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
4.0%
1/25 • Number of events 1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
Gastrointestinal disorders
Tongue pigmentation
0.00%
0/4 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/13 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/9 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/3 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/3 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
7.1%
1/14 • Number of events 1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/14 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/6 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/21 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/4 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/22 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/25 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
Gastrointestinal disorders
Toothache
0.00%
0/4 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
7.7%
1/13 • Number of events 1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/9 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/3 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/3 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/14 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/14 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/6 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/21 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/4 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/22 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/25 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
Gastrointestinal disorders
Upper gastrointestinal haemorrhage
0.00%
0/4 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/13 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/9 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/3 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/3 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/14 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/14 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/6 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
4.8%
1/21 • Number of events 1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/4 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/22 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/25 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
Gastrointestinal disorders
Vomiting
25.0%
1/4 • Number of events 2 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
38.5%
5/13 • Number of events 5 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
11.1%
1/9 • Number of events 1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
33.3%
1/3 • Number of events 1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
66.7%
2/3 • Number of events 2 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
28.6%
4/14 • Number of events 10 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
14.3%
2/14 • Number of events 2 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
16.7%
1/6 • Number of events 1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
47.6%
10/21 • Number of events 15 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
50.0%
2/4 • Number of events 2 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
31.8%
7/22 • Number of events 12 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
16.0%
4/25 • Number of events 4 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
General disorders
Asthenia
0.00%
0/4 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/13 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/9 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/3 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/3 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/14 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/14 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/6 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
4.8%
1/21 • Number of events 2 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
25.0%
1/4 • Number of events 1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
9.1%
2/22 • Number of events 2 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
20.0%
5/25 • Number of events 7 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
General disorders
Axillary pain
0.00%
0/4 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/13 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/9 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/3 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/3 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/14 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/14 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/6 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/21 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/4 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/22 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
4.0%
1/25 • Number of events 1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
General disorders
Chest pain
0.00%
0/4 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/13 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/9 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/3 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/3 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/14 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
7.1%
1/14 • Number of events 1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/6 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/21 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/4 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
9.1%
2/22 • Number of events 2 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/25 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
General disorders
Chills
25.0%
1/4 • Number of events 1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
7.7%
1/13 • Number of events 1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/9 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/3 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/3 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
14.3%
2/14 • Number of events 2 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/14 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/6 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/21 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/4 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/22 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/25 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
General disorders
Early satiety
0.00%
0/4 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/13 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/9 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/3 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/3 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
7.1%
1/14 • Number of events 1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/14 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/6 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/21 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
25.0%
1/4 • Number of events 1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/22 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/25 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
General disorders
Fatigue
50.0%
2/4 • Number of events 2 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
69.2%
9/13 • Number of events 10 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
55.6%
5/9 • Number of events 5 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
33.3%
1/3 • Number of events 2 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
33.3%
1/3 • Number of events 1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
71.4%
10/14 • Number of events 10 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
28.6%
4/14 • Number of events 6 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
33.3%
2/6 • Number of events 2 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
57.1%
12/21 • Number of events 13 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
75.0%
3/4 • Number of events 3 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
59.1%
13/22 • Number of events 19 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
28.0%
7/25 • Number of events 9 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
General disorders
Gait disturbance
0.00%
0/4 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/13 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/9 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/3 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/3 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/14 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/14 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/6 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/21 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/4 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
4.5%
1/22 • Number of events 1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/25 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
General disorders
Localised oedema
0.00%
0/4 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
7.7%
1/13 • Number of events 1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/9 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/3 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/3 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/14 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/14 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/6 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/21 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/4 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/22 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/25 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
General disorders
Malaise
0.00%
0/4 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/13 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
11.1%
1/9 • Number of events 1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/3 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/3 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/14 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/14 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/6 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/21 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/4 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/22 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/25 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
General disorders
Non-cardiac chest pain
0.00%
0/4 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
7.7%
1/13 • Number of events 1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/9 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
33.3%
1/3 • Number of events 1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/3 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/14 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/14 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/6 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/21 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/4 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/22 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/25 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
General disorders
Oedema peripheral
0.00%
0/4 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
15.4%
2/13 • Number of events 2 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
22.2%
2/9 • Number of events 2 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
33.3%
1/3 • Number of events 1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/3 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
21.4%
3/14 • Number of events 3 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/14 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
16.7%
1/6 • Number of events 1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/21 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/4 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
4.5%
1/22 • Number of events 1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/25 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
General disorders
Pain
0.00%
0/4 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
7.7%
1/13 • Number of events 1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/9 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/3 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/3 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/14 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/14 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/6 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/21 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/4 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/22 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/25 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
General disorders
Peripheral swelling
0.00%
0/4 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/13 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/9 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/3 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/3 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
7.1%
1/14 • Number of events 1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
7.1%
1/14 • Number of events 1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/6 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/21 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/4 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/22 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
4.0%
1/25 • Number of events 1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
General disorders
Pyrexia
25.0%
1/4 • Number of events 1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
7.7%
1/13 • Number of events 2 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
11.1%
1/9 • Number of events 1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/3 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
33.3%
1/3 • Number of events 1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
28.6%
4/14 • Number of events 5 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
7.1%
1/14 • Number of events 1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/6 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
4.8%
1/21 • Number of events 2 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
50.0%
2/4 • Number of events 2 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/22 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
4.0%
1/25 • Number of events 1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
General disorders
Sluggishness
0.00%
0/4 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
7.7%
1/13 • Number of events 1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/9 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/3 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/3 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/14 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/14 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/6 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/21 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/4 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/22 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/25 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
General disorders
Vascular device occlusion
0.00%
0/4 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
7.7%
1/13 • Number of events 3 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/9 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/3 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/3 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/14 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/14 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/6 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/21 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/4 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/22 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/25 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
Hepatobiliary disorders
Gallbladder obstruction
0.00%
0/4 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/13 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/9 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/3 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/3 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/14 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/14 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
16.7%
1/6 • Number of events 1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/21 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/4 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/22 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/25 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
Hepatobiliary disorders
Hypertransaminasaemia
0.00%
0/4 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
7.7%
1/13 • Number of events 2 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/9 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/3 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/3 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/14 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/14 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/6 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/21 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/4 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
4.5%
1/22 • Number of events 1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/25 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
Immune system disorders
Seasonal allergy
0.00%
0/4 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/13 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/9 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/3 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
33.3%
1/3 • Number of events 1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/14 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/14 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/6 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/21 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/4 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/22 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/25 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
Infections and infestations
Bronchitis
0.00%
0/4 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/13 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/9 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/3 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/3 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/14 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/14 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/6 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/21 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/4 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
4.5%
1/22 • Number of events 1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/25 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
Infections and infestations
COVID-19
0.00%
0/4 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
7.7%
1/13 • Number of events 1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/9 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/3 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/3 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/14 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/14 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/6 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/21 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/4 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/22 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
8.0%
2/25 • Number of events 2 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
Infections and infestations
Clostridium difficile infection
0.00%
0/4 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/13 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/9 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/3 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/3 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
7.1%
1/14 • Number of events 1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/14 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/6 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/21 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/4 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/22 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/25 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
Infections and infestations
Cystitis
0.00%
0/4 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/13 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/9 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/3 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/3 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
7.1%
1/14 • Number of events 2 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/14 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/6 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/21 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/4 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/22 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/25 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
Infections and infestations
Gastroenteritis viral
0.00%
0/4 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
7.7%
1/13 • Number of events 1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/9 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/3 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/3 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/14 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/14 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
16.7%
1/6 • Number of events 1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/21 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/4 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/22 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/25 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
Infections and infestations
Groin abscess
0.00%
0/4 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/13 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/9 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/3 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/3 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
7.1%
1/14 • Number of events 1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/14 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/6 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/21 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/4 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/22 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/25 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
Infections and infestations
Groin infection
0.00%
0/4 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/13 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/9 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/3 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/3 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
7.1%
1/14 • Number of events 1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/14 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/6 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/21 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/4 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/22 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/25 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
Infections and infestations
Herpes zoster
0.00%
0/4 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
7.7%
1/13 • Number of events 1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/9 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/3 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/3 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
7.1%
1/14 • Number of events 1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/14 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/6 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/21 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
25.0%
1/4 • Number of events 1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/22 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/25 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
Infections and infestations
Infected bite
0.00%
0/4 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/13 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/9 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/3 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/3 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/14 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/14 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/6 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
4.8%
1/21 • Number of events 1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/4 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/22 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/25 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
Infections and infestations
Influenza
0.00%
0/4 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/13 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/9 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/3 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/3 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/14 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
7.1%
1/14 • Number of events 1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/6 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/21 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/4 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
4.5%
1/22 • Number of events 1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/25 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
Infections and infestations
Lower respiratory tract infection
0.00%
0/4 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/13 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/9 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/3 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/3 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/14 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/14 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/6 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
4.8%
1/21 • Number of events 1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/4 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
4.5%
1/22 • Number of events 1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
8.0%
2/25 • Number of events 3 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
Infections and infestations
Nasopharyngitis
0.00%
0/4 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/13 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/9 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/3 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/3 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/14 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/14 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/6 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/21 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/4 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
4.5%
1/22 • Number of events 1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
100.0%
1/1 • Number of events 1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/25 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
Infections and infestations
Onychomycosis
0.00%
0/4 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/13 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/9 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/3 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
33.3%
1/3 • Number of events 1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/14 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/14 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/6 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/21 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/4 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/22 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/25 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
Infections and infestations
Oral herpes
0.00%
0/4 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/13 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/9 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/3 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/3 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/14 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
7.1%
1/14 • Number of events 1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/6 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/21 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/4 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/22 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/25 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
Infections and infestations
Oropharyngeal candidiasis
0.00%
0/4 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/13 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/9 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/3 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/3 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/14 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/14 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/6 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/21 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/4 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
4.5%
1/22 • Number of events 1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/25 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
Infections and infestations
Pneumonia
0.00%
0/4 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/13 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/9 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/3 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/3 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/14 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/14 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/6 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/21 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/4 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/22 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
4.0%
1/25 • Number of events 1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
Infections and infestations
Respiratory tract infection
0.00%
0/4 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/13 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/9 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/3 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/3 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/14 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/14 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/6 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/21 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/4 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/22 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
8.0%
2/25 • Number of events 4 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
Infections and infestations
Sinusitis
0.00%
0/4 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/13 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/9 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/3 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/3 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/14 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/14 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/6 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/21 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/4 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/22 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
4.0%
1/25 • Number of events 1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
Infections and infestations
Tooth infection
0.00%
0/4 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/13 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/9 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/3 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/3 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/14 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/14 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/6 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/21 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/4 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
4.5%
1/22 • Number of events 1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/25 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
Infections and infestations
Upper respiratory tract infection
0.00%
0/4 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
7.7%
1/13 • Number of events 1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
11.1%
1/9 • Number of events 1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
33.3%
1/3 • Number of events 1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/3 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
7.1%
1/14 • Number of events 1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
7.1%
1/14 • Number of events 1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/6 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
4.8%
1/21 • Number of events 1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/4 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
9.1%
2/22 • Number of events 2 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
4.0%
1/25 • Number of events 1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
Infections and infestations
Urinary tract infection
0.00%
0/4 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
7.7%
1/13 • Number of events 1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/9 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/3 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/3 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
14.3%
2/14 • Number of events 2 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
14.3%
2/14 • Number of events 2 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/6 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
4.8%
1/21 • Number of events 1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
50.0%
2/4 • Number of events 3 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/22 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
8.0%
2/25 • Number of events 2 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
Infections and infestations
Viral upper respiratory tract infection
0.00%
0/4 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/13 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/9 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/3 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/3 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
7.1%
1/14 • Number of events 1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/14 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/6 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/21 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/4 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/22 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/25 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
Injury, poisoning and procedural complications
Compression fracture
0.00%
0/4 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/13 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/9 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/3 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
33.3%
1/3 • Number of events 1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/14 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/14 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/6 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/21 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/4 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/22 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/25 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
Injury, poisoning and procedural complications
Contusion
0.00%
0/4 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
15.4%
2/13 • Number of events 2 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/9 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/3 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
33.3%
1/3 • Number of events 1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/14 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/14 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/6 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/21 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/4 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/22 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
100.0%
1/1 • Number of events 1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/25 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
Injury, poisoning and procedural complications
Fall
0.00%
0/4 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
7.7%
1/13 • Number of events 3 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
11.1%
1/9 • Number of events 1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/3 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/3 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
7.1%
1/14 • Number of events 2 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/14 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/6 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/21 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/4 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/22 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
4.0%
1/25 • Number of events 1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
Injury, poisoning and procedural complications
Fibula fracture
0.00%
0/4 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/13 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/9 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
33.3%
1/3 • Number of events 1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/3 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/14 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/14 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/6 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/21 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/4 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/22 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/25 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
Injury, poisoning and procedural complications
Foot fracture
0.00%
0/4 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/13 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
11.1%
1/9 • Number of events 1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/3 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/3 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/14 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/14 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/6 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/21 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/4 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/22 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/25 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
Injury, poisoning and procedural complications
Procedural pain
0.00%
0/4 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
7.7%
1/13 • Number of events 1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/9 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/3 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/3 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/14 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/14 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/6 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/21 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/4 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/22 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
4.0%
1/25 • Number of events 1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
Injury, poisoning and procedural complications
Radius fracture
0.00%
0/4 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/13 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/9 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/3 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/3 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/14 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/14 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/6 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/21 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/4 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/22 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
4.0%
1/25 • Number of events 1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
Injury, poisoning and procedural complications
Skin abrasion
0.00%
0/4 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/13 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
11.1%
1/9 • Number of events 1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/3 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
33.3%
1/3 • Number of events 1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/14 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/14 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/6 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/21 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/4 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/22 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/25 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
Investigations
Alanine aminotransferase increased
0.00%
0/4 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/13 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
11.1%
1/9 • Number of events 1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/3 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/3 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
21.4%
3/14 • Number of events 3 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/14 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
16.7%
1/6 • Number of events 1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
9.5%
2/21 • Number of events 2 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/4 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/22 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
20.0%
5/25 • Number of events 5 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
Investigations
Aspartate aminotransferase increased
0.00%
0/4 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
15.4%
2/13 • Number of events 2 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
11.1%
1/9 • Number of events 1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/3 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/3 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
21.4%
3/14 • Number of events 3 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
7.1%
1/14 • Number of events 1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
33.3%
2/6 • Number of events 2 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
14.3%
3/21 • Number of events 3 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/4 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
4.5%
1/22 • Number of events 1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
8.0%
2/25 • Number of events 2 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
Investigations
Blood alkaline phosphatase increased
0.00%
0/4 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
7.7%
1/13 • Number of events 1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
22.2%
2/9 • Number of events 2 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/3 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/3 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/14 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/14 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/6 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
9.5%
2/21 • Number of events 2 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/4 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/22 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
4.0%
1/25 • Number of events 1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
Investigations
Blood bilirubin increased
0.00%
0/4 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
15.4%
2/13 • Number of events 4 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/9 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/3 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/3 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
21.4%
3/14 • Number of events 3 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/14 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
16.7%
1/6 • Number of events 1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
9.5%
2/21 • Number of events 4 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/4 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/22 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
100.0%
1/1 • Number of events 2 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
8.0%
2/25 • Number of events 2 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
Investigations
Blood calcium decreased
0.00%
0/4 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/13 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/9 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/3 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/3 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/14 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/14 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/6 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/21 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/4 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/22 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
100.0%
1/1 • Number of events 1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/25 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
Investigations
Blood creatinine increased
0.00%
0/4 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/13 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/9 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/3 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/3 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/14 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
7.1%
1/14 • Number of events 1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/6 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
4.8%
1/21 • Number of events 1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/4 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
4.5%
1/22 • Number of events 1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/25 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
Investigations
Gamma-glutamyltransferase increased
0.00%
0/4 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/13 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/9 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/3 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/3 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/14 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/14 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/6 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
4.8%
1/21 • Number of events 1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/4 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/22 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/25 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
Investigations
Lymphocyte count decreased
0.00%
0/4 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/13 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
11.1%
1/9 • Number of events 1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/3 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/3 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
7.1%
1/14 • Number of events 1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/14 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/6 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/21 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/4 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/22 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/25 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
Investigations
Neutrophil count decreased
0.00%
0/4 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
15.4%
2/13 • Number of events 2 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
22.2%
2/9 • Number of events 2 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
33.3%
1/3 • Number of events 1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/3 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
14.3%
2/14 • Number of events 2 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
21.4%
3/14 • Number of events 4 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
33.3%
2/6 • Number of events 2 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
19.0%
4/21 • Number of events 5 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/4 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
31.8%
7/22 • Number of events 11 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
32.0%
8/25 • Number of events 15 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
Investigations
Platelet count decreased
25.0%
1/4 • Number of events 1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/13 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
33.3%
3/9 • Number of events 5 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
33.3%
1/3 • Number of events 1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/3 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
14.3%
2/14 • Number of events 2 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
21.4%
3/14 • Number of events 7 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
33.3%
2/6 • Number of events 2 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
23.8%
5/21 • Number of events 5 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
25.0%
1/4 • Number of events 1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
40.9%
9/22 • Number of events 14 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
100.0%
1/1 • Number of events 6 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
32.0%
8/25 • Number of events 8 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
Investigations
Weight decreased
0.00%
0/4 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/13 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
22.2%
2/9 • Number of events 2 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
66.7%
2/3 • Number of events 2 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
33.3%
1/3 • Number of events 1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/14 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
14.3%
2/14 • Number of events 2 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/6 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
9.5%
2/21 • Number of events 2 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/4 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/22 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
100.0%
1/1 • Number of events 1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
8.0%
2/25 • Number of events 2 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
Investigations
White blood cell count decreased
0.00%
0/4 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
7.7%
1/13 • Number of events 1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
33.3%
3/9 • Number of events 3 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/3 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/3 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
7.1%
1/14 • Number of events 1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
14.3%
2/14 • Number of events 3 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
33.3%
2/6 • Number of events 2 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
4.8%
1/21 • Number of events 1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/4 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
18.2%
4/22 • Number of events 4 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
8.0%
2/25 • Number of events 2 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
Metabolism and nutrition disorders
Decreased appetite
25.0%
1/4 • Number of events 1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
46.2%
6/13 • Number of events 6 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
22.2%
2/9 • Number of events 2 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
33.3%
1/3 • Number of events 1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/3 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
28.6%
4/14 • Number of events 4 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
35.7%
5/14 • Number of events 8 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
16.7%
1/6 • Number of events 1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
38.1%
8/21 • Number of events 8 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
75.0%
3/4 • Number of events 3 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
50.0%
11/22 • Number of events 12 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
16.0%
4/25 • Number of events 5 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
Metabolism and nutrition disorders
Dehydration
25.0%
1/4 • Number of events 1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
23.1%
3/13 • Number of events 3 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
11.1%
1/9 • Number of events 1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
33.3%
1/3 • Number of events 1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/3 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
35.7%
5/14 • Number of events 5 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
14.3%
2/14 • Number of events 2 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/6 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/21 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/4 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/22 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/25 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
Metabolism and nutrition disorders
Gout
0.00%
0/4 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/13 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/9 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/3 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/3 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/14 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/14 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
16.7%
1/6 • Number of events 1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/21 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/4 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/22 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/25 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
Metabolism and nutrition disorders
Hypercalcaemia
0.00%
0/4 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
7.7%
1/13 • Number of events 1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/9 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/3 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/3 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/14 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
7.1%
1/14 • Number of events 1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/6 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/21 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/4 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/22 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
4.0%
1/25 • Number of events 1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
Metabolism and nutrition disorders
Hyperglycaemia
0.00%
0/4 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/13 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
11.1%
1/9 • Number of events 1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/3 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/3 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
14.3%
2/14 • Number of events 2 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
7.1%
1/14 • Number of events 1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
16.7%
1/6 • Number of events 1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/21 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/4 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/22 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/25 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
Metabolism and nutrition disorders
Hyperkalaemia
0.00%
0/4 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/13 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/9 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/3 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/3 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/14 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
21.4%
3/14 • Number of events 6 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/6 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
4.8%
1/21 • Number of events 1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/4 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/22 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/25 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
Metabolism and nutrition disorders
Hypernatraemia
0.00%
0/4 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
7.7%
1/13 • Number of events 1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/9 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/3 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/3 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/14 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/14 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/6 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/21 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/4 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/22 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/25 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
Metabolism and nutrition disorders
Hypoalbuminaemia
0.00%
0/4 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/13 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/9 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/3 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/3 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/14 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/14 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
16.7%
1/6 • Number of events 1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/21 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/4 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
4.5%
1/22 • Number of events 1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/25 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
Metabolism and nutrition disorders
Hypocalcaemia
0.00%
0/4 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/13 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/9 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/3 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/3 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
7.1%
1/14 • Number of events 1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
7.1%
1/14 • Number of events 2 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/6 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/21 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/4 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/22 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/25 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
Metabolism and nutrition disorders
Hypokalaemia
0.00%
0/4 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
7.7%
1/13 • Number of events 1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/9 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
33.3%
1/3 • Number of events 2 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
33.3%
1/3 • Number of events 2 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
28.6%
4/14 • Number of events 6 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
7.1%
1/14 • Number of events 1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/6 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
4.8%
1/21 • Number of events 1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/4 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
4.5%
1/22 • Number of events 1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/25 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
Metabolism and nutrition disorders
Hypomagnesaemia
0.00%
0/4 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/13 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/9 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/3 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/3 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/14 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/14 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/6 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/21 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
25.0%
1/4 • Number of events 1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/22 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/25 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
Metabolism and nutrition disorders
Hyponatraemia
0.00%
0/4 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
7.7%
1/13 • Number of events 1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/9 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/3 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/3 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
14.3%
2/14 • Number of events 2 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/14 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/6 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
9.5%
2/21 • Number of events 2 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/4 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/22 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/25 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
Metabolism and nutrition disorders
Hypophosphataemia
25.0%
1/4 • Number of events 1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/13 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
11.1%
1/9 • Number of events 2 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/3 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/3 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
7.1%
1/14 • Number of events 3 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
14.3%
2/14 • Number of events 3 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
16.7%
1/6 • Number of events 1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
4.8%
1/21 • Number of events 1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/4 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/22 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/25 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
Metabolism and nutrition disorders
Vitamin B12 deficiency
0.00%
0/4 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
7.7%
1/13 • Number of events 1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/9 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/3 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/3 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/14 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/14 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/6 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/21 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/4 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/22 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/25 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
Metabolism and nutrition disorders
Vitamin D deficiency
0.00%
0/4 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/13 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/9 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/3 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/3 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
7.1%
1/14 • Number of events 1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/14 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/6 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/21 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/4 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/22 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/25 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
Musculoskeletal and connective tissue disorders
Arthralgia
25.0%
1/4 • Number of events 1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
30.8%
4/13 • Number of events 4 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/9 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
33.3%
1/3 • Number of events 1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
33.3%
1/3 • Number of events 2 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
14.3%
2/14 • Number of events 2 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
7.1%
1/14 • Number of events 1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
16.7%
1/6 • Number of events 2 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
4.8%
1/21 • Number of events 1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
25.0%
1/4 • Number of events 1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
13.6%
3/22 • Number of events 4 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
4.0%
1/25 • Number of events 1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
Musculoskeletal and connective tissue disorders
Back pain
0.00%
0/4 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
7.7%
1/13 • Number of events 1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/9 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/3 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
66.7%
2/3 • Number of events 3 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/14 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
7.1%
1/14 • Number of events 1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
16.7%
1/6 • Number of events 1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
4.8%
1/21 • Number of events 1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
25.0%
1/4 • Number of events 1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
22.7%
5/22 • Number of events 5 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
16.0%
4/25 • Number of events 4 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
Musculoskeletal and connective tissue disorders
Flank pain
0.00%
0/4 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/13 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/9 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/3 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
33.3%
1/3 • Number of events 1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/14 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/14 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/6 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
4.8%
1/21 • Number of events 1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/4 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
4.5%
1/22 • Number of events 1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
4.0%
1/25 • Number of events 1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
Musculoskeletal and connective tissue disorders
Groin pain
0.00%
0/4 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/13 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/9 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/3 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/3 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/14 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
7.1%
1/14 • Number of events 1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/6 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/21 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/4 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/22 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/25 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
Musculoskeletal and connective tissue disorders
Muscle spasms
0.00%
0/4 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
23.1%
3/13 • Number of events 4 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
11.1%
1/9 • Number of events 1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
33.3%
1/3 • Number of events 1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
33.3%
1/3 • Number of events 1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
21.4%
3/14 • Number of events 3 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/14 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/6 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
4.8%
1/21 • Number of events 1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/4 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/22 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
4.0%
1/25 • Number of events 1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
Musculoskeletal and connective tissue disorders
Muscle tightness
0.00%
0/4 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/13 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/9 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/3 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/3 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/14 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/14 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/6 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
4.8%
1/21 • Number of events 1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/4 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/22 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/25 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
Musculoskeletal and connective tissue disorders
Muscular weakness
25.0%
1/4 • Number of events 1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
7.7%
1/13 • Number of events 1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/9 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/3 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/3 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
7.1%
1/14 • Number of events 2 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/14 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/6 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/21 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/4 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/22 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
4.0%
1/25 • Number of events 1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
0.00%
0/4 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
7.7%
1/13 • Number of events 1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
11.1%
1/9 • Number of events 1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/3 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/3 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
14.3%
2/14 • Number of events 2 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/14 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/6 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/21 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/4 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
9.1%
2/22 • Number of events 2 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
8.0%
2/25 • Number of events 2 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
0.00%
0/4 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
7.7%
1/13 • Number of events 1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/9 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/3 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/3 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/14 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
7.1%
1/14 • Number of events 1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/6 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/21 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/4 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/22 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
4.0%
1/25 • Number of events 1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
Musculoskeletal and connective tissue disorders
Myalgia
0.00%
0/4 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
7.7%
1/13 • Number of events 1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/9 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
33.3%
1/3 • Number of events 1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
33.3%
1/3 • Number of events 1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/14 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
7.1%
1/14 • Number of events 1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/6 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/21 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/4 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
4.5%
1/22 • Number of events 1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
4.0%
1/25 • Number of events 1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
Musculoskeletal and connective tissue disorders
Neck pain
0.00%
0/4 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/13 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/9 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/3 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/3 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
7.1%
1/14 • Number of events 1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/14 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/6 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
4.8%
1/21 • Number of events 1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/4 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
4.5%
1/22 • Number of events 1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
4.0%
1/25 • Number of events 2 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
Musculoskeletal and connective tissue disorders
Osteopenia
0.00%
0/4 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/13 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/9 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/3 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
33.3%
1/3 • Number of events 1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/14 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/14 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/6 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/21 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/4 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/22 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/25 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
Musculoskeletal and connective tissue disorders
Pain in extremity
0.00%
0/4 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
15.4%
2/13 • Number of events 2 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
11.1%
1/9 • Number of events 1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/3 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/3 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
14.3%
2/14 • Number of events 2 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/14 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/6 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/21 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/4 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/22 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
4.0%
1/25 • Number of events 1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder transitional cell carcinoma
0.00%
0/4 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/13 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/9 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/3 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
33.3%
1/3 • Number of events 1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/14 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/14 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/6 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/21 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/4 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/22 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/25 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cancer pain
0.00%
0/4 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/13 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
11.1%
1/9 • Number of events 1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/3 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/3 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
7.1%
1/14 • Number of events 1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/14 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/6 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
9.5%
2/21 • Number of events 2 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/4 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/22 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/25 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Infected neoplasm
0.00%
0/4 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/13 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/9 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/3 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/3 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/14 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/14 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/6 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/21 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/4 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
4.5%
1/22 • Number of events 1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/25 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant ascites
0.00%
0/4 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/13 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/9 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/3 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/3 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/14 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/14 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/6 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
4.8%
1/21 • Number of events 1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/4 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/22 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/25 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
Nervous system disorders
Aphasia
0.00%
0/4 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/13 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
11.1%
1/9 • Number of events 1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/3 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/3 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/14 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/14 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/6 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/21 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/4 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/22 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/25 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
Nervous system disorders
Areflexia
0.00%
0/4 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/13 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/9 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/3 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/3 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/14 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/14 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/6 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
4.8%
1/21 • Number of events 1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/4 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/22 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/25 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
Nervous system disorders
Balance disorder
0.00%
0/4 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/13 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/9 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/3 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/3 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/14 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/14 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/6 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/21 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/4 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
4.5%
1/22 • Number of events 1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/25 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
Nervous system disorders
Cognitive disorder
0.00%
0/4 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/13 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/9 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/3 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/3 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
14.3%
2/14 • Number of events 2 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/14 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/6 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/21 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/4 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/22 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/25 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
Nervous system disorders
Depressed level of consciousness
0.00%
0/4 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/13 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/9 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/3 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/3 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/14 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/14 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/6 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/21 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/4 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
4.5%
1/22 • Number of events 1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/25 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
Nervous system disorders
Dizziness
25.0%
1/4 • Number of events 1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
7.7%
1/13 • Number of events 1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
11.1%
1/9 • Number of events 1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
33.3%
1/3 • Number of events 1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/3 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
21.4%
3/14 • Number of events 3 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
28.6%
4/14 • Number of events 4 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/6 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
9.5%
2/21 • Number of events 2 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
25.0%
1/4 • Number of events 2 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
4.5%
1/22 • Number of events 1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/25 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
Nervous system disorders
Dizziness postural
0.00%
0/4 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
7.7%
1/13 • Number of events 1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/9 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/3 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/3 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/14 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/14 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/6 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/21 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/4 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/22 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/25 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
Nervous system disorders
Dysaesthesia
0.00%
0/4 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/13 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/9 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/3 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/3 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/14 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/14 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/6 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/21 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/4 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
4.5%
1/22 • Number of events 1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/25 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
Nervous system disorders
Dysarthria
0.00%
0/4 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/13 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/9 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/3 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/3 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/14 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/14 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/6 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/21 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/4 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
4.5%
1/22 • Number of events 1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/25 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
Nervous system disorders
Dysgeusia
25.0%
1/4 • Number of events 1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
7.7%
1/13 • Number of events 1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
11.1%
1/9 • Number of events 1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/3 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/3 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
14.3%
2/14 • Number of events 2 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/14 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/6 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
4.8%
1/21 • Number of events 1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
25.0%
1/4 • Number of events 1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
4.5%
1/22 • Number of events 1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
4.0%
1/25 • Number of events 1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
Nervous system disorders
Headache
0.00%
0/4 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
30.8%
4/13 • Number of events 4 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/9 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/3 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/3 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
21.4%
3/14 • Number of events 3 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
14.3%
2/14 • Number of events 2 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/6 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/21 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
25.0%
1/4 • Number of events 3 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
18.2%
4/22 • Number of events 6 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
100.0%
1/1 • Number of events 1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
8.0%
2/25 • Number of events 2 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
Nervous system disorders
Hemiparesis
0.00%
0/4 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/13 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/9 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/3 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/3 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/14 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/14 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/6 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/21 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/4 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
4.5%
1/22 • Number of events 1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/25 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
Nervous system disorders
Lethargy
0.00%
0/4 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/13 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/9 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/3 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/3 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/14 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/14 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/6 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
4.8%
1/21 • Number of events 1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/4 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
4.5%
1/22 • Number of events 1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/25 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
Nervous system disorders
Lumbar radiculopathy
0.00%
0/4 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/13 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/9 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/3 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
33.3%
1/3 • Number of events 1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/14 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/14 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/6 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/21 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/4 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/22 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/25 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
Nervous system disorders
Mental impairment
25.0%
1/4 • Number of events 1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/13 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/9 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/3 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/3 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/14 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/14 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/6 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/21 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/4 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/22 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/25 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
Nervous system disorders
Multiple sclerosis
0.00%
0/4 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
7.7%
1/13 • Number of events 1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/9 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/3 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/3 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/14 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/14 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/6 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/21 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/4 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/22 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/25 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
Nervous system disorders
Paraparesis
0.00%
0/4 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/13 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/9 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/3 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/3 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/14 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/14 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/6 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/21 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/4 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/22 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
4.0%
1/25 • Number of events 1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
Nervous system disorders
Parosmia
0.00%
0/4 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/13 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/9 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/3 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/3 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/14 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/14 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/6 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/21 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/4 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
4.5%
1/22 • Number of events 1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/25 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
Nervous system disorders
Peripheral motor neuropathy
0.00%
0/4 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/13 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/9 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/3 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/3 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
7.1%
1/14 • Number of events 1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/14 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/6 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/21 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/4 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/22 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/25 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
Nervous system disorders
Peripheral sensory neuropathy
0.00%
0/4 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
7.7%
1/13 • Number of events 1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/9 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/3 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/3 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/14 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/14 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/6 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
9.5%
2/21 • Number of events 2 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/4 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/22 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/25 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
Nervous system disorders
Sciatica
0.00%
0/4 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
7.7%
1/13 • Number of events 1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/9 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/3 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/3 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/14 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/14 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/6 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/21 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/4 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/22 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/25 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
Nervous system disorders
Somnolence
0.00%
0/4 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/13 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/9 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/3 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/3 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/14 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/14 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/6 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
9.5%
2/21 • Number of events 2 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/4 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
13.6%
3/22 • Number of events 3 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/25 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
Nervous system disorders
Taste disorder
25.0%
1/4 • Number of events 1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/13 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/9 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/3 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/3 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/14 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/14 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/6 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/21 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/4 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
4.5%
1/22 • Number of events 1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/25 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
Nervous system disorders
Tremor
0.00%
0/4 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
7.7%
1/13 • Number of events 1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/9 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/3 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/3 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/14 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/14 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/6 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/21 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/4 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/22 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/25 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
Psychiatric disorders
Anxiety
0.00%
0/4 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/13 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/9 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/3 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/3 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
7.1%
1/14 • Number of events 1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/14 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/6 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/21 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/4 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/22 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
100.0%
1/1 • Number of events 1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/25 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
Psychiatric disorders
Depression
0.00%
0/4 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
7.7%
1/13 • Number of events 1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/9 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/3 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/3 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/14 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/14 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
33.3%
2/6 • Number of events 2 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
4.8%
1/21 • Number of events 1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/4 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
4.5%
1/22 • Number of events 1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/25 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
Psychiatric disorders
Hallucination
0.00%
0/4 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/13 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/9 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/3 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/3 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/14 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/14 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/6 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/21 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/4 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
4.5%
1/22 • Number of events 1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/25 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
Psychiatric disorders
Insomnia
0.00%
0/4 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
23.1%
3/13 • Number of events 3 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
11.1%
1/9 • Number of events 1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/3 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/3 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
14.3%
2/14 • Number of events 2 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/14 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
33.3%
2/6 • Number of events 2 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
4.8%
1/21 • Number of events 1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
25.0%
1/4 • Number of events 1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
4.5%
1/22 • Number of events 1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
8.0%
2/25 • Number of events 2 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
Renal and urinary disorders
Acute kidney injury
0.00%
0/4 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
7.7%
1/13 • Number of events 1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/9 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/3 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/3 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
7.1%
1/14 • Number of events 1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/14 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/6 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/21 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/4 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/22 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/25 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
Renal and urinary disorders
Dysuria
0.00%
0/4 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
7.7%
1/13 • Number of events 1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/9 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/3 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/3 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
7.1%
1/14 • Number of events 1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/14 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/6 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/21 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
25.0%
1/4 • Number of events 1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/22 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/25 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
Renal and urinary disorders
Haematuria
0.00%
0/4 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/13 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/9 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/3 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
33.3%
1/3 • Number of events 1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/14 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/14 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/6 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/21 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/4 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/22 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/25 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
Renal and urinary disorders
Nephrolithiasis
0.00%
0/4 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
7.7%
1/13 • Number of events 1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/9 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/3 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/3 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/14 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/14 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/6 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/21 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/4 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/22 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/25 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
Renal and urinary disorders
Nocturia
0.00%
0/4 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/13 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/9 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/3 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/3 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
7.1%
1/14 • Number of events 1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/14 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/6 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/21 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/4 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/22 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/25 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
Renal and urinary disorders
Pollakiuria
0.00%
0/4 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/13 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/9 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/3 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/3 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/14 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/14 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/6 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
4.8%
1/21 • Number of events 1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/4 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/22 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
4.0%
1/25 • Number of events 1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
Renal and urinary disorders
Proteinuria
0.00%
0/4 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/13 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/9 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/3 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
33.3%
1/3 • Number of events 1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/14 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/14 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
16.7%
1/6 • Number of events 1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/21 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/4 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/22 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/25 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
Renal and urinary disorders
Renal colic
0.00%
0/4 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/13 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/9 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/3 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/3 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/14 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/14 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/6 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/21 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/4 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
4.5%
1/22 • Number of events 1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/25 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
Renal and urinary disorders
Urethral stenosis
0.00%
0/4 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
7.7%
1/13 • Number of events 1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/9 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/3 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/3 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/14 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/14 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/6 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/21 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/4 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/22 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/25 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
Renal and urinary disorders
Urinary incontinence
0.00%
0/4 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/13 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/9 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/3 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/3 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
7.1%
1/14 • Number of events 1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/14 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/6 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/21 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/4 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/22 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/25 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
Renal and urinary disorders
Urinary retention
0.00%
0/4 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
7.7%
1/13 • Number of events 1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/9 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/3 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/3 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/14 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/14 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/6 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/21 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/4 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/22 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/25 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
Reproductive system and breast disorders
Heavy menstrual bleeding
0.00%
0/4 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/13 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/9 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/3 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/3 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/14 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/14 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/6 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
4.8%
1/21 • Number of events 1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/4 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/22 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/25 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
Reproductive system and breast disorders
Nipple pain
0.00%
0/4 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/13 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/9 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/3 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
33.3%
1/3 • Number of events 1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/14 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/14 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/6 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/21 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/4 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/22 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/25 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
Respiratory, thoracic and mediastinal disorders
Aphonia
0.00%
0/4 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/13 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/9 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/3 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/3 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/14 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/14 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/6 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/21 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/4 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/22 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
4.0%
1/25 • Number of events 1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
Respiratory, thoracic and mediastinal disorders
Cough
50.0%
2/4 • Number of events 2 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
15.4%
2/13 • Number of events 2 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
11.1%
1/9 • Number of events 2 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
33.3%
1/3 • Number of events 1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/3 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
21.4%
3/14 • Number of events 3 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
14.3%
2/14 • Number of events 2 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/6 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
4.8%
1/21 • Number of events 1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
25.0%
1/4 • Number of events 1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
22.7%
5/22 • Number of events 6 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
16.0%
4/25 • Number of events 6 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
Respiratory, thoracic and mediastinal disorders
Dysphonia
0.00%
0/4 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/13 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/9 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/3 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/3 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/14 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/14 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/6 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/21 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/4 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
9.1%
2/22 • Number of events 2 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
4.0%
1/25 • Number of events 1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
Respiratory, thoracic and mediastinal disorders
Dyspnoea
25.0%
1/4 • Number of events 1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
23.1%
3/13 • Number of events 3 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
11.1%
1/9 • Number of events 1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
33.3%
1/3 • Number of events 4 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/3 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
14.3%
2/14 • Number of events 2 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
14.3%
2/14 • Number of events 2 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
16.7%
1/6 • Number of events 1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
4.8%
1/21 • Number of events 1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/4 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
9.1%
2/22 • Number of events 2 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
12.0%
3/25 • Number of events 3 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
0.00%
0/4 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
15.4%
2/13 • Number of events 2 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/9 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/3 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/3 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/14 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
7.1%
1/14 • Number of events 2 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/6 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/21 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
25.0%
1/4 • Number of events 1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/22 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/25 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
Respiratory, thoracic and mediastinal disorders
Epistaxis
0.00%
0/4 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
15.4%
2/13 • Number of events 2 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
11.1%
1/9 • Number of events 1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/3 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/3 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/14 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
7.1%
1/14 • Number of events 1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/6 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/21 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/4 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
4.5%
1/22 • Number of events 1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/25 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
Respiratory, thoracic and mediastinal disorders
Haemoptysis
0.00%
0/4 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/13 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/9 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/3 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/3 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
7.1%
1/14 • Number of events 1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/14 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/6 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/21 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/4 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
4.5%
1/22 • Number of events 1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
4.0%
1/25 • Number of events 1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
Respiratory, thoracic and mediastinal disorders
Hiccups
0.00%
0/4 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/13 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/9 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/3 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/3 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/14 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/14 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/6 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
14.3%
3/21 • Number of events 3 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/4 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
4.5%
1/22 • Number of events 1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/25 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
Respiratory, thoracic and mediastinal disorders
Hypoxia
0.00%
0/4 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/13 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/9 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/3 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/3 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/14 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
7.1%
1/14 • Number of events 1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/6 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/21 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/4 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/22 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/25 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
Respiratory, thoracic and mediastinal disorders
Increased bronchial secretion
0.00%
0/4 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/13 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/9 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/3 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/3 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/14 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/14 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/6 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/21 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/4 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
4.5%
1/22 • Number of events 1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/25 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
Respiratory, thoracic and mediastinal disorders
Increased upper airway secretion
0.00%
0/4 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/13 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/9 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/3 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/3 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/14 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/14 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/6 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/21 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/4 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
4.5%
1/22 • Number of events 1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/25 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
Respiratory, thoracic and mediastinal disorders
Nasal congestion
0.00%
0/4 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/13 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/9 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
33.3%
1/3 • Number of events 1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/3 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/14 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
7.1%
1/14 • Number of events 1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/6 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/21 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/4 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/22 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/25 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
Respiratory, thoracic and mediastinal disorders
Nasal inflammation
0.00%
0/4 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/13 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/9 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/3 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/3 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/14 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/14 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/6 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/21 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/4 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
4.5%
1/22 • Number of events 1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/25 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
0.00%
0/4 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
7.7%
1/13 • Number of events 1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/9 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/3 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/3 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/14 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/14 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/6 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/21 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
25.0%
1/4 • Number of events 2 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
4.5%
1/22 • Number of events 1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/25 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
Respiratory, thoracic and mediastinal disorders
Pleural effusion
25.0%
1/4 • Number of events 1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/13 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/9 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
33.3%
1/3 • Number of events 3 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/3 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/14 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/14 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/6 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/21 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/4 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/22 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
4.0%
1/25 • Number of events 1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
Respiratory, thoracic and mediastinal disorders
Productive cough
0.00%
0/4 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
7.7%
1/13 • Number of events 1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/9 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/3 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/3 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/14 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/14 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/6 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/21 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/4 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
9.1%
2/22 • Number of events 2 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
8.0%
2/25 • Number of events 2 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
0.00%
0/4 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/13 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/9 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/3 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/3 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/14 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
7.1%
1/14 • Number of events 1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/6 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/21 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/4 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/22 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/25 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
Respiratory, thoracic and mediastinal disorders
Rhinitis allergic
0.00%
0/4 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/13 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/9 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/3 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/3 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/14 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
14.3%
2/14 • Number of events 2 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/6 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/21 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/4 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/22 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/25 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
Respiratory, thoracic and mediastinal disorders
Sinus congestion
0.00%
0/4 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
7.7%
1/13 • Number of events 2 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/9 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
33.3%
1/3 • Number of events 1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/3 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/14 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/14 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/6 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/21 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/4 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/22 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/25 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
Respiratory, thoracic and mediastinal disorders
Wheezing
0.00%
0/4 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
7.7%
1/13 • Number of events 1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/9 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/3 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/3 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/14 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/14 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/6 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
4.8%
1/21 • Number of events 1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/4 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/22 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/25 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
Skin and subcutaneous tissue disorders
Alopecia
0.00%
0/4 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/13 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/9 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/3 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/3 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/14 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
7.1%
1/14 • Number of events 1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/6 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/21 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/4 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/22 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/25 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
Skin and subcutaneous tissue disorders
Dry skin
0.00%
0/4 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/13 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/9 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/3 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/3 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/14 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/14 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
16.7%
1/6 • Number of events 1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
4.8%
1/21 • Number of events 1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
25.0%
1/4 • Number of events 1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/22 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
4.0%
1/25 • Number of events 1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
Skin and subcutaneous tissue disorders
Ecchymosis
0.00%
0/4 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/13 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/9 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/3 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/3 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
7.1%
1/14 • Number of events 1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/14 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/6 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/21 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/4 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/22 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/25 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
Skin and subcutaneous tissue disorders
Hyperhidrosis
0.00%
0/4 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/13 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
11.1%
1/9 • Number of events 1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/3 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/3 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/14 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/14 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/6 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/21 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/4 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/22 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/25 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
Skin and subcutaneous tissue disorders
Nail discolouration
0.00%
0/4 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
7.7%
1/13 • Number of events 1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/9 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/3 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/3 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/14 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/14 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/6 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/21 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/4 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/22 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/25 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
Skin and subcutaneous tissue disorders
Nail disorder
0.00%
0/4 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/13 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/9 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/3 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/3 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
7.1%
1/14 • Number of events 1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/14 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/6 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/21 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/4 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/22 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/25 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
Skin and subcutaneous tissue disorders
Onychoclasis
0.00%
0/4 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/13 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/9 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
33.3%
1/3 • Number of events 1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/3 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/14 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/14 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/6 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/21 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/4 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/22 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/25 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
Skin and subcutaneous tissue disorders
Pruritus
0.00%
0/4 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/13 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/9 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/3 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/3 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/14 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/14 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
16.7%
1/6 • Number of events 1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
4.8%
1/21 • Number of events 1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/4 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
4.5%
1/22 • Number of events 1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
4.0%
1/25 • Number of events 1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
Skin and subcutaneous tissue disorders
Rash
0.00%
0/4 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/13 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
11.1%
1/9 • Number of events 1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/3 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/3 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/14 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
7.1%
1/14 • Number of events 1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/6 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
4.8%
1/21 • Number of events 1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/4 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/22 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
100.0%
1/1 • Number of events 1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/25 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
Skin and subcutaneous tissue disorders
Rash maculo-papular
0.00%
0/4 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/13 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/9 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/3 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/3 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/14 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/14 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/6 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/21 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/4 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
4.5%
1/22 • Number of events 2 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
4.0%
1/25 • Number of events 1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
Skin and subcutaneous tissue disorders
Xanthoma
0.00%
0/4 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
7.7%
1/13 • Number of events 1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/9 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/3 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/3 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/14 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/14 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/6 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/21 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/4 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/22 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/25 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
Vascular disorders
Capillary fragility
0.00%
0/4 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/13 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/9 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/3 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/3 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/14 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/14 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/6 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/21 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/4 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/22 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
4.0%
1/25 • Number of events 1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
Vascular disorders
Deep vein thrombosis
0.00%
0/4 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
7.7%
1/13 • Number of events 1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/9 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/3 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/3 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
7.1%
1/14 • Number of events 1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/14 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/6 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/21 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/4 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/22 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/25 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
Vascular disorders
Haematoma
0.00%
0/4 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/13 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/9 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/3 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/3 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/14 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/14 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/6 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/21 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/4 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
4.5%
1/22 • Number of events 1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/25 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
Vascular disorders
Hot flush
0.00%
0/4 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/13 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
11.1%
1/9 • Number of events 1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/3 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/3 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
7.1%
1/14 • Number of events 1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/14 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/6 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/21 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/4 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/22 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/25 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
Vascular disorders
Hypertension
0.00%
0/4 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/13 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/9 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/3 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/3 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
14.3%
2/14 • Number of events 2 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/14 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/6 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/21 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/4 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
4.5%
1/22 • Number of events 2 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/25 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
Vascular disorders
Hypotension
0.00%
0/4 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/13 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/9 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/3 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/3 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/14 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
7.1%
1/14 • Number of events 1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/6 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/21 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/4 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/22 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/25 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
Vascular disorders
Peripheral venous disease
0.00%
0/4 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/13 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/9 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/3 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
33.3%
1/3 • Number of events 1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/14 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/14 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/6 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/21 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/4 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/22 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
0.00%
0/25 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 5 years and 10 months
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.

Additional Information

Study Director

BeiGene

Phone: +1-877-828-5568

Results disclosure agreements

  • Principal investigator is a sponsor employee BeiGene has 18 months from the end of the study at all sites to publish overall study results. After the 1st multi-site publication or the expiration of publication period, Investigators are free to publish/present the results of the study. Investigators must submit all draft publications/presentations to us for review 60 days prior to the planned publication/presentation date. BeiGene may request deletion of its confidential information \& may request a further delay to protect its IP rights
  • Publication restrictions are in place

Restriction type: OTHER