Trial Outcomes & Findings for Study To Investigate the Efficacy and Safety of Sitravatinib in Combination With Tislelizumab in Participants With Esophageal Squamous Cell Carcinoma (NCT NCT05461794)
NCT ID: NCT05461794
Last Updated: 2025-06-13
Results Overview
ORR is defined as the percentage of participants with a confirmed complete response (CR) or partial response (PR) as assessed by the investigator per the Response Evaluation Criteria in Solid Tumors (RECIST) Version (v) 1.1.
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
96 participants
Primary outcome timeframe
Through study completion data cut-off date of February 26th, 2024 (maximum time on study was 12 months)
Results posted on
2025-06-13
Participant Flow
Participants were enrolled across multiple study centers in China. The first participant provided consent on October 3, 2022, and the last participant completed the study on February 26, 2024.
Participants were randomly assigned to one of three treatment groups in a 2:1:2 ratio. Randomization was stratified by PD-L1 expressions status (Tumor Area Positivity \[TAP\] score ≥ 10% versus TAP score \< 10%)
Participant milestones
| Measure |
Arm A: Tislelizumab + Sitravatinib
Sitravatinib was administered orally at a dose of 100 mg once daily, while tislelizumab was given intravenously at 200 mg once every three weeks.
|
Arm B: Sitravatinib
Sitravatinib was administered orally at a dose of 100 mg once daily.
|
Arm C: Investigator-chosen Chemotherapy (ICC)
Investigators selected either docetaxel, administered intravenously at 75 mg/m² on Day 1 of each 21-day cycle, or irinotecan, given intravenously at 125 mg/m² on Days 1 and 8 of each 21-day cycle.
|
|---|---|---|---|
|
Overall Study
STARTED
|
39
|
19
|
38
|
|
Overall Study
Treated
|
39
|
19
|
34
|
|
Overall Study
COMPLETED
|
0
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
39
|
19
|
38
|
Reasons for withdrawal
| Measure |
Arm A: Tislelizumab + Sitravatinib
Sitravatinib was administered orally at a dose of 100 mg once daily, while tislelizumab was given intravenously at 200 mg once every three weeks.
|
Arm B: Sitravatinib
Sitravatinib was administered orally at a dose of 100 mg once daily.
|
Arm C: Investigator-chosen Chemotherapy (ICC)
Investigators selected either docetaxel, administered intravenously at 75 mg/m² on Day 1 of each 21-day cycle, or irinotecan, given intravenously at 125 mg/m² on Days 1 and 8 of each 21-day cycle.
|
|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
1
|
3
|
|
Overall Study
Study Terminated By Sponsor
|
18
|
13
|
16
|
|
Overall Study
Death
|
20
|
5
|
19
|
Baseline Characteristics
Study To Investigate the Efficacy and Safety of Sitravatinib in Combination With Tislelizumab in Participants With Esophageal Squamous Cell Carcinoma
Baseline characteristics by cohort
| Measure |
Arm A: Tislelizumab + Sitravatinib
n=39 Participants
Sitravatinib was administered orally at a dose of 100 mg once daily, while tislelizumab was given intravenously at 200 mg once every three weeks.
|
Arm B: Sitravatinib
n=19 Participants
Sitravatinib was administered orally at a dose of 100 mg once daily.
|
Arm C: Investigator-chosen Chemotherapy (ICC)
n=38 Participants
Investigators selected either docetaxel, administered intravenously at 75 mg/m² on Day 1 of each 21-day cycle, or irinotecan, given intravenously at 125 mg/m² on Days 1 and 8 of each 21-day cycle.
|
Total
n=96 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
59.1 years
STANDARD_DEVIATION 7.73 • n=93 Participants
|
61.9 years
STANDARD_DEVIATION 7.87 • n=4 Participants
|
60.4 years
STANDARD_DEVIATION 8.06 • n=27 Participants
|
60.2 years
STANDARD_DEVIATION 7.87 • n=483 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=93 Participants
|
2 Participants
n=4 Participants
|
3 Participants
n=27 Participants
|
7 Participants
n=483 Participants
|
|
Sex: Female, Male
Male
|
37 Participants
n=93 Participants
|
17 Participants
n=4 Participants
|
35 Participants
n=27 Participants
|
89 Participants
n=483 Participants
|
|
Race/Ethnicity, Customized
Asian
|
39 Participants
n=93 Participants
|
19 Participants
n=4 Participants
|
38 Participants
n=27 Participants
|
96 Participants
n=483 Participants
|
PRIMARY outcome
Timeframe: Through study completion data cut-off date of February 26th, 2024 (maximum time on study was 12 months)Population: The Intent-to-Treat (ITT) analysis set included all randomized participants; for the primary analysis of ORR only Arms A and C were included, results for Arm B are included in the secondary Outcome Measures section.
ORR is defined as the percentage of participants with a confirmed complete response (CR) or partial response (PR) as assessed by the investigator per the Response Evaluation Criteria in Solid Tumors (RECIST) Version (v) 1.1.
Outcome measures
| Measure |
Arm A: Tislelizumab + Sitravatinib
n=39 Participants
Sitravatinib was administered orally at a dose of 100 mg once daily, while tislelizumab was given intravenously at 200 mg once every three weeks.
|
Arm C: Investigator-chosen Chemotherapy (ICC)
n=38 Participants
Investigators selected either docetaxel, administered intravenously at 75 mg/m² on Day 1 of each 21-day cycle, or irinotecan, given intravenously at 125 mg/m² on Days 1 and 8 of each 21-day cycle.
|
Arm C: Investigator-chosen Chemotherapy (ICC)
Investigators selected either docetaxel, administered intravenously at 75 mg/m² on Day 1 of each 21-day cycle, or irinotecan, given intravenously at 125 mg/m² on Days 1 and 8 of each 21-day cycle.
|
|---|---|---|---|
|
Arms A and C: Overall Response Rate (ORR)
|
10.3 percentage of participants
Interval 2.9 to 24.2
|
5.3 percentage of participants
Interval 0.6 to 17.7
|
—
|
SECONDARY outcome
Timeframe: Through study completion data cut-off date of February 26th, 2024 (maximum time on study was 12 months)Population: ITT analysis Set. Only participants with best overall response of complete response or partial response confirmed per RECIST v1.1 were included in the analysis, and percentages were based on the number of responders
Defined as the time from the first occurrence of a documented objective response to the time of documented disease progression assessed by the investigator or death from any cause, whichever occurred first, in all randomized participants with documented objective responses.
Outcome measures
| Measure |
Arm A: Tislelizumab + Sitravatinib
n=4 Participants
Sitravatinib was administered orally at a dose of 100 mg once daily, while tislelizumab was given intravenously at 200 mg once every three weeks.
|
Arm C: Investigator-chosen Chemotherapy (ICC)
n=4 Participants
Investigators selected either docetaxel, administered intravenously at 75 mg/m² on Day 1 of each 21-day cycle, or irinotecan, given intravenously at 125 mg/m² on Days 1 and 8 of each 21-day cycle.
|
Arm C: Investigator-chosen Chemotherapy (ICC)
n=2 Participants
Investigators selected either docetaxel, administered intravenously at 75 mg/m² on Day 1 of each 21-day cycle, or irinotecan, given intravenously at 125 mg/m² on Days 1 and 8 of each 21-day cycle.
|
|---|---|---|---|
|
Duration of Response (DOR)
|
5.2 months
Interval 4.4 to
Not estimable due to insufficient number of participants with events
|
4.6 months
Interval 2.8 to
Not estimable due to insufficient number of participants with events
|
NA months
Interval 2.8 to
Not estimable due to insufficient number of participants with events
|
SECONDARY outcome
Timeframe: Through study completion data cut-off date of February 26th, 2024 (maximum time on study was 12 months)Population: ITT analysis set
Defined as the time from randomization until the date of death due to any cause. Kaplan-Meier methodology was used to estimate the median OS.
Outcome measures
| Measure |
Arm A: Tislelizumab + Sitravatinib
n=39 Participants
Sitravatinib was administered orally at a dose of 100 mg once daily, while tislelizumab was given intravenously at 200 mg once every three weeks.
|
Arm C: Investigator-chosen Chemotherapy (ICC)
n=19 Participants
Investigators selected either docetaxel, administered intravenously at 75 mg/m² on Day 1 of each 21-day cycle, or irinotecan, given intravenously at 125 mg/m² on Days 1 and 8 of each 21-day cycle.
|
Arm C: Investigator-chosen Chemotherapy (ICC)
n=38 Participants
Investigators selected either docetaxel, administered intravenously at 75 mg/m² on Day 1 of each 21-day cycle, or irinotecan, given intravenously at 125 mg/m² on Days 1 and 8 of each 21-day cycle.
|
|---|---|---|---|
|
Overall Survival (OS)
|
6.1 months
Interval 3.4 to 7.5
|
9.1 months
Interval 6.5 to
Not estimable due to insufficient number of participants with events
|
5.5 months
Interval 4.7 to 6.6
|
SECONDARY outcome
Timeframe: Through study completion data cut-off date of February 26th, 2024 (maximum time on study was 12 months)Population: ITT analysis set
Defined as the percentage of participants whose best overall response is complete response, partial response, or stable disease, as assessed by the investigator per RECIST v1.1
Outcome measures
| Measure |
Arm A: Tislelizumab + Sitravatinib
n=39 Participants
Sitravatinib was administered orally at a dose of 100 mg once daily, while tislelizumab was given intravenously at 200 mg once every three weeks.
|
Arm C: Investigator-chosen Chemotherapy (ICC)
n=19 Participants
Investigators selected either docetaxel, administered intravenously at 75 mg/m² on Day 1 of each 21-day cycle, or irinotecan, given intravenously at 125 mg/m² on Days 1 and 8 of each 21-day cycle.
|
Arm C: Investigator-chosen Chemotherapy (ICC)
n=38 Participants
Investigators selected either docetaxel, administered intravenously at 75 mg/m² on Day 1 of each 21-day cycle, or irinotecan, given intravenously at 125 mg/m² on Days 1 and 8 of each 21-day cycle.
|
|---|---|---|---|
|
Disease Control Rate (DCR)
|
64.1 percentage of participants
Interval 47.2 to 78.8
|
63.2 percentage of participants
Interval 38.4 to 83.7
|
42.1 percentage of participants
Interval 26.3 to 59.2
|
SECONDARY outcome
Timeframe: Through study completion data cut-off date of February 26th, 2024 (maximum time on study was 12 months)Population: ITT analysis set
Defined as the percentage of participants with a complete response, partial response, or durable stable disease (defined as stable disease for 24 weeks or longer, as assessed by the investigator per RECIST v.1.1.
Outcome measures
| Measure |
Arm A: Tislelizumab + Sitravatinib
n=39 Participants
Sitravatinib was administered orally at a dose of 100 mg once daily, while tislelizumab was given intravenously at 200 mg once every three weeks.
|
Arm C: Investigator-chosen Chemotherapy (ICC)
n=19 Participants
Investigators selected either docetaxel, administered intravenously at 75 mg/m² on Day 1 of each 21-day cycle, or irinotecan, given intravenously at 125 mg/m² on Days 1 and 8 of each 21-day cycle.
|
Arm C: Investigator-chosen Chemotherapy (ICC)
n=38 Participants
Investigators selected either docetaxel, administered intravenously at 75 mg/m² on Day 1 of each 21-day cycle, or irinotecan, given intravenously at 125 mg/m² on Days 1 and 8 of each 21-day cycle.
|
|---|---|---|---|
|
Clinical Benefit Rate (CBR)
|
17.9 percentage of participants
Interval 7.5 to 33.5
|
26.3 percentage of participants
Interval 9.1 to 51.2
|
5.3 percentage of participants
Interval 0.6 to 17.7
|
SECONDARY outcome
Timeframe: Through study completion data cut-off date of February 26th, 2024 (maximum time on study was 12 months)Population: ITT analysis set
Defined as the time from randomization until first documentation of disease progression as assessed by the investigator per RECIST v1.1 or death from any cause, whichever occurred first. Kaplan-Meier methodology was used to estimate the median PFS.
Outcome measures
| Measure |
Arm A: Tislelizumab + Sitravatinib
n=39 Participants
Sitravatinib was administered orally at a dose of 100 mg once daily, while tislelizumab was given intravenously at 200 mg once every three weeks.
|
Arm C: Investigator-chosen Chemotherapy (ICC)
n=19 Participants
Investigators selected either docetaxel, administered intravenously at 75 mg/m² on Day 1 of each 21-day cycle, or irinotecan, given intravenously at 125 mg/m² on Days 1 and 8 of each 21-day cycle.
|
Arm C: Investigator-chosen Chemotherapy (ICC)
n=38 Participants
Investigators selected either docetaxel, administered intravenously at 75 mg/m² on Day 1 of each 21-day cycle, or irinotecan, given intravenously at 125 mg/m² on Days 1 and 8 of each 21-day cycle.
|
|---|---|---|---|
|
Progression Free Survival (PFS)
|
3.4 months
Interval 2.1 to 5.6
|
5.6 months
Interval 2.1 to
Not estimable due to insufficient number of participants with events
|
2.6 months
Interval 1.5 to 3.8
|
SECONDARY outcome
Timeframe: Through study completion data cut-off date of February 26th, 2024 (maximum time on study was 12 months)Population: ITT analysis set for Arms A and B
ORR is defined as the percentage of participants with a confirmed complete response (CR) or partial response (PR) as assessed by the investigator per RECIST v1.1. Analysis of ORR in Arm A compared to Arm B was specified as a secondary endpoint in the Protocol (please see the primary outcome measure for Arm C results)
Outcome measures
| Measure |
Arm A: Tislelizumab + Sitravatinib
n=39 Participants
Sitravatinib was administered orally at a dose of 100 mg once daily, while tislelizumab was given intravenously at 200 mg once every three weeks.
|
Arm C: Investigator-chosen Chemotherapy (ICC)
n=19 Participants
Investigators selected either docetaxel, administered intravenously at 75 mg/m² on Day 1 of each 21-day cycle, or irinotecan, given intravenously at 125 mg/m² on Days 1 and 8 of each 21-day cycle.
|
Arm C: Investigator-chosen Chemotherapy (ICC)
Investigators selected either docetaxel, administered intravenously at 75 mg/m² on Day 1 of each 21-day cycle, or irinotecan, given intravenously at 125 mg/m² on Days 1 and 8 of each 21-day cycle.
|
|---|---|---|---|
|
Arms A and B: Overall Response Rate (ORR)
|
10.3 percentage of participants
Interval 2.9 to 24.2
|
21.1 percentage of participants
Interval 6.1 to 45.6
|
—
|
SECONDARY outcome
Timeframe: From the first dose to 30 days after the last dose or the start of new anticancer therapy, whichever occurred first (maximum time on treatment was 8.9 months for Arm A, 7.7 months for Arm B, and 8.0 months for Arm C).Population: The Safety Analysis Set includes all participants who received at least 1 dose of any component of study treatments.
Number of participants with treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs), which includes laboratory tests, and vital signs, according to National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE) v5.0
Outcome measures
| Measure |
Arm A: Tislelizumab + Sitravatinib
n=39 Participants
Sitravatinib was administered orally at a dose of 100 mg once daily, while tislelizumab was given intravenously at 200 mg once every three weeks.
|
Arm C: Investigator-chosen Chemotherapy (ICC)
n=19 Participants
Investigators selected either docetaxel, administered intravenously at 75 mg/m² on Day 1 of each 21-day cycle, or irinotecan, given intravenously at 125 mg/m² on Days 1 and 8 of each 21-day cycle.
|
Arm C: Investigator-chosen Chemotherapy (ICC)
n=34 Participants
Investigators selected either docetaxel, administered intravenously at 75 mg/m² on Day 1 of each 21-day cycle, or irinotecan, given intravenously at 125 mg/m² on Days 1 and 8 of each 21-day cycle.
|
|---|---|---|---|
|
Number of Participants With Adverse Events
TEAEs
|
39 Participants
|
19 Participants
|
34 Participants
|
|
Number of Participants With Adverse Events
SAEs
|
22 Participants
|
6 Participants
|
15 Participants
|
Adverse Events
Arm A: Tislelizumab + Sitravatinib
Serious events: 22 serious events
Other events: 39 other events
Deaths: 20 deaths
Arm B: Sitravatinib
Serious events: 6 serious events
Other events: 19 other events
Deaths: 5 deaths
Arm C: Investigator-chosen Chemotherapy (ICC)
Serious events: 15 serious events
Other events: 34 other events
Deaths: 19 deaths
Serious adverse events
| Measure |
Arm A: Tislelizumab + Sitravatinib
n=39 participants at risk
Sitravatinib was administered orally at a dose of 100 mg once daily, while tislelizumab was given intravenously at 200 mg once every three weeks.
|
Arm B: Sitravatinib
n=19 participants at risk
Sitravatinib was administered orally at a dose of 100 mg once daily.
|
Arm C: Investigator-chosen Chemotherapy (ICC)
n=34 participants at risk
Investigators selected either docetaxel, administered intravenously at 75 mg/m² on Day 1 of each 21-day cycle, or irinotecan, given intravenously at 125 mg/m² on Days 1 and 8 of each 21-day cycle.
|
|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
2.6%
1/39 • Number of events 1 • All-cause mortality was assessed through the end of study, February 26th, 2024 (maximum time on study was 12 months). Adverse events were assessed from the first dose of study drug to 30 days after the last dose or the start of new anticancer therapy, whichever occurred first (maximum time on treatment was 8.9 months for Arm A, 7.7 months for Arm B, and 8.0 months for Arm C).
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
0.00%
0/19 • All-cause mortality was assessed through the end of study, February 26th, 2024 (maximum time on study was 12 months). Adverse events were assessed from the first dose of study drug to 30 days after the last dose or the start of new anticancer therapy, whichever occurred first (maximum time on treatment was 8.9 months for Arm A, 7.7 months for Arm B, and 8.0 months for Arm C).
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
0.00%
0/34 • All-cause mortality was assessed through the end of study, February 26th, 2024 (maximum time on study was 12 months). Adverse events were assessed from the first dose of study drug to 30 days after the last dose or the start of new anticancer therapy, whichever occurred first (maximum time on treatment was 8.9 months for Arm A, 7.7 months for Arm B, and 8.0 months for Arm C).
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
|
Blood and lymphatic system disorders
Coagulopathy
|
2.6%
1/39 • Number of events 1 • All-cause mortality was assessed through the end of study, February 26th, 2024 (maximum time on study was 12 months). Adverse events were assessed from the first dose of study drug to 30 days after the last dose or the start of new anticancer therapy, whichever occurred first (maximum time on treatment was 8.9 months for Arm A, 7.7 months for Arm B, and 8.0 months for Arm C).
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
0.00%
0/19 • All-cause mortality was assessed through the end of study, February 26th, 2024 (maximum time on study was 12 months). Adverse events were assessed from the first dose of study drug to 30 days after the last dose or the start of new anticancer therapy, whichever occurred first (maximum time on treatment was 8.9 months for Arm A, 7.7 months for Arm B, and 8.0 months for Arm C).
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
0.00%
0/34 • All-cause mortality was assessed through the end of study, February 26th, 2024 (maximum time on study was 12 months). Adverse events were assessed from the first dose of study drug to 30 days after the last dose or the start of new anticancer therapy, whichever occurred first (maximum time on treatment was 8.9 months for Arm A, 7.7 months for Arm B, and 8.0 months for Arm C).
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
|
Cardiac disorders
Acute coronary syndrome
|
2.6%
1/39 • Number of events 1 • All-cause mortality was assessed through the end of study, February 26th, 2024 (maximum time on study was 12 months). Adverse events were assessed from the first dose of study drug to 30 days after the last dose or the start of new anticancer therapy, whichever occurred first (maximum time on treatment was 8.9 months for Arm A, 7.7 months for Arm B, and 8.0 months for Arm C).
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
0.00%
0/19 • All-cause mortality was assessed through the end of study, February 26th, 2024 (maximum time on study was 12 months). Adverse events were assessed from the first dose of study drug to 30 days after the last dose or the start of new anticancer therapy, whichever occurred first (maximum time on treatment was 8.9 months for Arm A, 7.7 months for Arm B, and 8.0 months for Arm C).
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
0.00%
0/34 • All-cause mortality was assessed through the end of study, February 26th, 2024 (maximum time on study was 12 months). Adverse events were assessed from the first dose of study drug to 30 days after the last dose or the start of new anticancer therapy, whichever occurred first (maximum time on treatment was 8.9 months for Arm A, 7.7 months for Arm B, and 8.0 months for Arm C).
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
|
Cardiac disorders
Cardiac failure
|
2.6%
1/39 • Number of events 1 • All-cause mortality was assessed through the end of study, February 26th, 2024 (maximum time on study was 12 months). Adverse events were assessed from the first dose of study drug to 30 days after the last dose or the start of new anticancer therapy, whichever occurred first (maximum time on treatment was 8.9 months for Arm A, 7.7 months for Arm B, and 8.0 months for Arm C).
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
0.00%
0/19 • All-cause mortality was assessed through the end of study, February 26th, 2024 (maximum time on study was 12 months). Adverse events were assessed from the first dose of study drug to 30 days after the last dose or the start of new anticancer therapy, whichever occurred first (maximum time on treatment was 8.9 months for Arm A, 7.7 months for Arm B, and 8.0 months for Arm C).
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
0.00%
0/34 • All-cause mortality was assessed through the end of study, February 26th, 2024 (maximum time on study was 12 months). Adverse events were assessed from the first dose of study drug to 30 days after the last dose or the start of new anticancer therapy, whichever occurred first (maximum time on treatment was 8.9 months for Arm A, 7.7 months for Arm B, and 8.0 months for Arm C).
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
|
Cardiac disorders
Cardiogenic shock
|
2.6%
1/39 • Number of events 1 • All-cause mortality was assessed through the end of study, February 26th, 2024 (maximum time on study was 12 months). Adverse events were assessed from the first dose of study drug to 30 days after the last dose or the start of new anticancer therapy, whichever occurred first (maximum time on treatment was 8.9 months for Arm A, 7.7 months for Arm B, and 8.0 months for Arm C).
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
0.00%
0/19 • All-cause mortality was assessed through the end of study, February 26th, 2024 (maximum time on study was 12 months). Adverse events were assessed from the first dose of study drug to 30 days after the last dose or the start of new anticancer therapy, whichever occurred first (maximum time on treatment was 8.9 months for Arm A, 7.7 months for Arm B, and 8.0 months for Arm C).
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
0.00%
0/34 • All-cause mortality was assessed through the end of study, February 26th, 2024 (maximum time on study was 12 months). Adverse events were assessed from the first dose of study drug to 30 days after the last dose or the start of new anticancer therapy, whichever occurred first (maximum time on treatment was 8.9 months for Arm A, 7.7 months for Arm B, and 8.0 months for Arm C).
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
|
Cardiac disorders
Cardiomyopathy
|
2.6%
1/39 • Number of events 1 • All-cause mortality was assessed through the end of study, February 26th, 2024 (maximum time on study was 12 months). Adverse events were assessed from the first dose of study drug to 30 days after the last dose or the start of new anticancer therapy, whichever occurred first (maximum time on treatment was 8.9 months for Arm A, 7.7 months for Arm B, and 8.0 months for Arm C).
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
0.00%
0/19 • All-cause mortality was assessed through the end of study, February 26th, 2024 (maximum time on study was 12 months). Adverse events were assessed from the first dose of study drug to 30 days after the last dose or the start of new anticancer therapy, whichever occurred first (maximum time on treatment was 8.9 months for Arm A, 7.7 months for Arm B, and 8.0 months for Arm C).
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
0.00%
0/34 • All-cause mortality was assessed through the end of study, February 26th, 2024 (maximum time on study was 12 months). Adverse events were assessed from the first dose of study drug to 30 days after the last dose or the start of new anticancer therapy, whichever occurred first (maximum time on treatment was 8.9 months for Arm A, 7.7 months for Arm B, and 8.0 months for Arm C).
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
|
Cardiac disorders
Pericardial effusion
|
2.6%
1/39 • Number of events 1 • All-cause mortality was assessed through the end of study, February 26th, 2024 (maximum time on study was 12 months). Adverse events were assessed from the first dose of study drug to 30 days after the last dose or the start of new anticancer therapy, whichever occurred first (maximum time on treatment was 8.9 months for Arm A, 7.7 months for Arm B, and 8.0 months for Arm C).
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
0.00%
0/19 • All-cause mortality was assessed through the end of study, February 26th, 2024 (maximum time on study was 12 months). Adverse events were assessed from the first dose of study drug to 30 days after the last dose or the start of new anticancer therapy, whichever occurred first (maximum time on treatment was 8.9 months for Arm A, 7.7 months for Arm B, and 8.0 months for Arm C).
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
0.00%
0/34 • All-cause mortality was assessed through the end of study, February 26th, 2024 (maximum time on study was 12 months). Adverse events were assessed from the first dose of study drug to 30 days after the last dose or the start of new anticancer therapy, whichever occurred first (maximum time on treatment was 8.9 months for Arm A, 7.7 months for Arm B, and 8.0 months for Arm C).
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
|
Cardiac disorders
Pericarditis
|
2.6%
1/39 • Number of events 1 • All-cause mortality was assessed through the end of study, February 26th, 2024 (maximum time on study was 12 months). Adverse events were assessed from the first dose of study drug to 30 days after the last dose or the start of new anticancer therapy, whichever occurred first (maximum time on treatment was 8.9 months for Arm A, 7.7 months for Arm B, and 8.0 months for Arm C).
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
0.00%
0/19 • All-cause mortality was assessed through the end of study, February 26th, 2024 (maximum time on study was 12 months). Adverse events were assessed from the first dose of study drug to 30 days after the last dose or the start of new anticancer therapy, whichever occurred first (maximum time on treatment was 8.9 months for Arm A, 7.7 months for Arm B, and 8.0 months for Arm C).
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
0.00%
0/34 • All-cause mortality was assessed through the end of study, February 26th, 2024 (maximum time on study was 12 months). Adverse events were assessed from the first dose of study drug to 30 days after the last dose or the start of new anticancer therapy, whichever occurred first (maximum time on treatment was 8.9 months for Arm A, 7.7 months for Arm B, and 8.0 months for Arm C).
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
|
Cardiac disorders
Pneumopericardium
|
2.6%
1/39 • Number of events 1 • All-cause mortality was assessed through the end of study, February 26th, 2024 (maximum time on study was 12 months). Adverse events were assessed from the first dose of study drug to 30 days after the last dose or the start of new anticancer therapy, whichever occurred first (maximum time on treatment was 8.9 months for Arm A, 7.7 months for Arm B, and 8.0 months for Arm C).
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
0.00%
0/19 • All-cause mortality was assessed through the end of study, February 26th, 2024 (maximum time on study was 12 months). Adverse events were assessed from the first dose of study drug to 30 days after the last dose or the start of new anticancer therapy, whichever occurred first (maximum time on treatment was 8.9 months for Arm A, 7.7 months for Arm B, and 8.0 months for Arm C).
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
0.00%
0/34 • All-cause mortality was assessed through the end of study, February 26th, 2024 (maximum time on study was 12 months). Adverse events were assessed from the first dose of study drug to 30 days after the last dose or the start of new anticancer therapy, whichever occurred first (maximum time on treatment was 8.9 months for Arm A, 7.7 months for Arm B, and 8.0 months for Arm C).
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
|
Cardiac disorders
Supraventricular extrasystoles
|
2.6%
1/39 • Number of events 1 • All-cause mortality was assessed through the end of study, February 26th, 2024 (maximum time on study was 12 months). Adverse events were assessed from the first dose of study drug to 30 days after the last dose or the start of new anticancer therapy, whichever occurred first (maximum time on treatment was 8.9 months for Arm A, 7.7 months for Arm B, and 8.0 months for Arm C).
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
0.00%
0/19 • All-cause mortality was assessed through the end of study, February 26th, 2024 (maximum time on study was 12 months). Adverse events were assessed from the first dose of study drug to 30 days after the last dose or the start of new anticancer therapy, whichever occurred first (maximum time on treatment was 8.9 months for Arm A, 7.7 months for Arm B, and 8.0 months for Arm C).
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
0.00%
0/34 • All-cause mortality was assessed through the end of study, February 26th, 2024 (maximum time on study was 12 months). Adverse events were assessed from the first dose of study drug to 30 days after the last dose or the start of new anticancer therapy, whichever occurred first (maximum time on treatment was 8.9 months for Arm A, 7.7 months for Arm B, and 8.0 months for Arm C).
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
|
Endocrine disorders
Hypothyroidism
|
2.6%
1/39 • Number of events 1 • All-cause mortality was assessed through the end of study, February 26th, 2024 (maximum time on study was 12 months). Adverse events were assessed from the first dose of study drug to 30 days after the last dose or the start of new anticancer therapy, whichever occurred first (maximum time on treatment was 8.9 months for Arm A, 7.7 months for Arm B, and 8.0 months for Arm C).
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
0.00%
0/19 • All-cause mortality was assessed through the end of study, February 26th, 2024 (maximum time on study was 12 months). Adverse events were assessed from the first dose of study drug to 30 days after the last dose or the start of new anticancer therapy, whichever occurred first (maximum time on treatment was 8.9 months for Arm A, 7.7 months for Arm B, and 8.0 months for Arm C).
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
0.00%
0/34 • All-cause mortality was assessed through the end of study, February 26th, 2024 (maximum time on study was 12 months). Adverse events were assessed from the first dose of study drug to 30 days after the last dose or the start of new anticancer therapy, whichever occurred first (maximum time on treatment was 8.9 months for Arm A, 7.7 months for Arm B, and 8.0 months for Arm C).
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
|
Gastrointestinal disorders
Duodenitis
|
2.6%
1/39 • Number of events 1 • All-cause mortality was assessed through the end of study, February 26th, 2024 (maximum time on study was 12 months). Adverse events were assessed from the first dose of study drug to 30 days after the last dose or the start of new anticancer therapy, whichever occurred first (maximum time on treatment was 8.9 months for Arm A, 7.7 months for Arm B, and 8.0 months for Arm C).
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
0.00%
0/19 • All-cause mortality was assessed through the end of study, February 26th, 2024 (maximum time on study was 12 months). Adverse events were assessed from the first dose of study drug to 30 days after the last dose or the start of new anticancer therapy, whichever occurred first (maximum time on treatment was 8.9 months for Arm A, 7.7 months for Arm B, and 8.0 months for Arm C).
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
0.00%
0/34 • All-cause mortality was assessed through the end of study, February 26th, 2024 (maximum time on study was 12 months). Adverse events were assessed from the first dose of study drug to 30 days after the last dose or the start of new anticancer therapy, whichever occurred first (maximum time on treatment was 8.9 months for Arm A, 7.7 months for Arm B, and 8.0 months for Arm C).
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.00%
0/39 • All-cause mortality was assessed through the end of study, February 26th, 2024 (maximum time on study was 12 months). Adverse events were assessed from the first dose of study drug to 30 days after the last dose or the start of new anticancer therapy, whichever occurred first (maximum time on treatment was 8.9 months for Arm A, 7.7 months for Arm B, and 8.0 months for Arm C).
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
5.3%
1/19 • Number of events 1 • All-cause mortality was assessed through the end of study, February 26th, 2024 (maximum time on study was 12 months). Adverse events were assessed from the first dose of study drug to 30 days after the last dose or the start of new anticancer therapy, whichever occurred first (maximum time on treatment was 8.9 months for Arm A, 7.7 months for Arm B, and 8.0 months for Arm C).
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
0.00%
0/34 • All-cause mortality was assessed through the end of study, February 26th, 2024 (maximum time on study was 12 months). Adverse events were assessed from the first dose of study drug to 30 days after the last dose or the start of new anticancer therapy, whichever occurred first (maximum time on treatment was 8.9 months for Arm A, 7.7 months for Arm B, and 8.0 months for Arm C).
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.00%
0/39 • All-cause mortality was assessed through the end of study, February 26th, 2024 (maximum time on study was 12 months). Adverse events were assessed from the first dose of study drug to 30 days after the last dose or the start of new anticancer therapy, whichever occurred first (maximum time on treatment was 8.9 months for Arm A, 7.7 months for Arm B, and 8.0 months for Arm C).
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
5.3%
1/19 • Number of events 1 • All-cause mortality was assessed through the end of study, February 26th, 2024 (maximum time on study was 12 months). Adverse events were assessed from the first dose of study drug to 30 days after the last dose or the start of new anticancer therapy, whichever occurred first (maximum time on treatment was 8.9 months for Arm A, 7.7 months for Arm B, and 8.0 months for Arm C).
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
2.9%
1/34 • Number of events 1 • All-cause mortality was assessed through the end of study, February 26th, 2024 (maximum time on study was 12 months). Adverse events were assessed from the first dose of study drug to 30 days after the last dose or the start of new anticancer therapy, whichever occurred first (maximum time on treatment was 8.9 months for Arm A, 7.7 months for Arm B, and 8.0 months for Arm C).
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
|
Gastrointestinal disorders
Ileus
|
2.6%
1/39 • Number of events 1 • All-cause mortality was assessed through the end of study, February 26th, 2024 (maximum time on study was 12 months). Adverse events were assessed from the first dose of study drug to 30 days after the last dose or the start of new anticancer therapy, whichever occurred first (maximum time on treatment was 8.9 months for Arm A, 7.7 months for Arm B, and 8.0 months for Arm C).
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
0.00%
0/19 • All-cause mortality was assessed through the end of study, February 26th, 2024 (maximum time on study was 12 months). Adverse events were assessed from the first dose of study drug to 30 days after the last dose or the start of new anticancer therapy, whichever occurred first (maximum time on treatment was 8.9 months for Arm A, 7.7 months for Arm B, and 8.0 months for Arm C).
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
0.00%
0/34 • All-cause mortality was assessed through the end of study, February 26th, 2024 (maximum time on study was 12 months). Adverse events were assessed from the first dose of study drug to 30 days after the last dose or the start of new anticancer therapy, whichever occurred first (maximum time on treatment was 8.9 months for Arm A, 7.7 months for Arm B, and 8.0 months for Arm C).
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/39 • All-cause mortality was assessed through the end of study, February 26th, 2024 (maximum time on study was 12 months). Adverse events were assessed from the first dose of study drug to 30 days after the last dose or the start of new anticancer therapy, whichever occurred first (maximum time on treatment was 8.9 months for Arm A, 7.7 months for Arm B, and 8.0 months for Arm C).
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
0.00%
0/19 • All-cause mortality was assessed through the end of study, February 26th, 2024 (maximum time on study was 12 months). Adverse events were assessed from the first dose of study drug to 30 days after the last dose or the start of new anticancer therapy, whichever occurred first (maximum time on treatment was 8.9 months for Arm A, 7.7 months for Arm B, and 8.0 months for Arm C).
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
2.9%
1/34 • Number of events 1 • All-cause mortality was assessed through the end of study, February 26th, 2024 (maximum time on study was 12 months). Adverse events were assessed from the first dose of study drug to 30 days after the last dose or the start of new anticancer therapy, whichever occurred first (maximum time on treatment was 8.9 months for Arm A, 7.7 months for Arm B, and 8.0 months for Arm C).
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
|
Gastrointestinal disorders
Obstruction gastric
|
2.6%
1/39 • Number of events 1 • All-cause mortality was assessed through the end of study, February 26th, 2024 (maximum time on study was 12 months). Adverse events were assessed from the first dose of study drug to 30 days after the last dose or the start of new anticancer therapy, whichever occurred first (maximum time on treatment was 8.9 months for Arm A, 7.7 months for Arm B, and 8.0 months for Arm C).
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
0.00%
0/19 • All-cause mortality was assessed through the end of study, February 26th, 2024 (maximum time on study was 12 months). Adverse events were assessed from the first dose of study drug to 30 days after the last dose or the start of new anticancer therapy, whichever occurred first (maximum time on treatment was 8.9 months for Arm A, 7.7 months for Arm B, and 8.0 months for Arm C).
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
0.00%
0/34 • All-cause mortality was assessed through the end of study, February 26th, 2024 (maximum time on study was 12 months). Adverse events were assessed from the first dose of study drug to 30 days after the last dose or the start of new anticancer therapy, whichever occurred first (maximum time on treatment was 8.9 months for Arm A, 7.7 months for Arm B, and 8.0 months for Arm C).
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
|
Gastrointestinal disorders
Oesophageal fistula
|
5.1%
2/39 • Number of events 2 • All-cause mortality was assessed through the end of study, February 26th, 2024 (maximum time on study was 12 months). Adverse events were assessed from the first dose of study drug to 30 days after the last dose or the start of new anticancer therapy, whichever occurred first (maximum time on treatment was 8.9 months for Arm A, 7.7 months for Arm B, and 8.0 months for Arm C).
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
0.00%
0/19 • All-cause mortality was assessed through the end of study, February 26th, 2024 (maximum time on study was 12 months). Adverse events were assessed from the first dose of study drug to 30 days after the last dose or the start of new anticancer therapy, whichever occurred first (maximum time on treatment was 8.9 months for Arm A, 7.7 months for Arm B, and 8.0 months for Arm C).
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
0.00%
0/34 • All-cause mortality was assessed through the end of study, February 26th, 2024 (maximum time on study was 12 months). Adverse events were assessed from the first dose of study drug to 30 days after the last dose or the start of new anticancer therapy, whichever occurred first (maximum time on treatment was 8.9 months for Arm A, 7.7 months for Arm B, and 8.0 months for Arm C).
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
|
Gastrointestinal disorders
Oesophageal obstruction
|
0.00%
0/39 • All-cause mortality was assessed through the end of study, February 26th, 2024 (maximum time on study was 12 months). Adverse events were assessed from the first dose of study drug to 30 days after the last dose or the start of new anticancer therapy, whichever occurred first (maximum time on treatment was 8.9 months for Arm A, 7.7 months for Arm B, and 8.0 months for Arm C).
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
5.3%
1/19 • Number of events 1 • All-cause mortality was assessed through the end of study, February 26th, 2024 (maximum time on study was 12 months). Adverse events were assessed from the first dose of study drug to 30 days after the last dose or the start of new anticancer therapy, whichever occurred first (maximum time on treatment was 8.9 months for Arm A, 7.7 months for Arm B, and 8.0 months for Arm C).
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
2.9%
1/34 • Number of events 1 • All-cause mortality was assessed through the end of study, February 26th, 2024 (maximum time on study was 12 months). Adverse events were assessed from the first dose of study drug to 30 days after the last dose or the start of new anticancer therapy, whichever occurred first (maximum time on treatment was 8.9 months for Arm A, 7.7 months for Arm B, and 8.0 months for Arm C).
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
|
Gastrointestinal disorders
Pancreatitis
|
2.6%
1/39 • Number of events 1 • All-cause mortality was assessed through the end of study, February 26th, 2024 (maximum time on study was 12 months). Adverse events were assessed from the first dose of study drug to 30 days after the last dose or the start of new anticancer therapy, whichever occurred first (maximum time on treatment was 8.9 months for Arm A, 7.7 months for Arm B, and 8.0 months for Arm C).
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
0.00%
0/19 • All-cause mortality was assessed through the end of study, February 26th, 2024 (maximum time on study was 12 months). Adverse events were assessed from the first dose of study drug to 30 days after the last dose or the start of new anticancer therapy, whichever occurred first (maximum time on treatment was 8.9 months for Arm A, 7.7 months for Arm B, and 8.0 months for Arm C).
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
0.00%
0/34 • All-cause mortality was assessed through the end of study, February 26th, 2024 (maximum time on study was 12 months). Adverse events were assessed from the first dose of study drug to 30 days after the last dose or the start of new anticancer therapy, whichever occurred first (maximum time on treatment was 8.9 months for Arm A, 7.7 months for Arm B, and 8.0 months for Arm C).
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
|
Gastrointestinal disorders
Upper gastrointestinal haemorrhage
|
5.1%
2/39 • Number of events 3 • All-cause mortality was assessed through the end of study, February 26th, 2024 (maximum time on study was 12 months). Adverse events were assessed from the first dose of study drug to 30 days after the last dose or the start of new anticancer therapy, whichever occurred first (maximum time on treatment was 8.9 months for Arm A, 7.7 months for Arm B, and 8.0 months for Arm C).
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
0.00%
0/19 • All-cause mortality was assessed through the end of study, February 26th, 2024 (maximum time on study was 12 months). Adverse events were assessed from the first dose of study drug to 30 days after the last dose or the start of new anticancer therapy, whichever occurred first (maximum time on treatment was 8.9 months for Arm A, 7.7 months for Arm B, and 8.0 months for Arm C).
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
0.00%
0/34 • All-cause mortality was assessed through the end of study, February 26th, 2024 (maximum time on study was 12 months). Adverse events were assessed from the first dose of study drug to 30 days after the last dose or the start of new anticancer therapy, whichever occurred first (maximum time on treatment was 8.9 months for Arm A, 7.7 months for Arm B, and 8.0 months for Arm C).
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
|
Gastrointestinal disorders
Vomiting
|
2.6%
1/39 • Number of events 1 • All-cause mortality was assessed through the end of study, February 26th, 2024 (maximum time on study was 12 months). Adverse events were assessed from the first dose of study drug to 30 days after the last dose or the start of new anticancer therapy, whichever occurred first (maximum time on treatment was 8.9 months for Arm A, 7.7 months for Arm B, and 8.0 months for Arm C).
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
0.00%
0/19 • All-cause mortality was assessed through the end of study, February 26th, 2024 (maximum time on study was 12 months). Adverse events were assessed from the first dose of study drug to 30 days after the last dose or the start of new anticancer therapy, whichever occurred first (maximum time on treatment was 8.9 months for Arm A, 7.7 months for Arm B, and 8.0 months for Arm C).
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
0.00%
0/34 • All-cause mortality was assessed through the end of study, February 26th, 2024 (maximum time on study was 12 months). Adverse events were assessed from the first dose of study drug to 30 days after the last dose or the start of new anticancer therapy, whichever occurred first (maximum time on treatment was 8.9 months for Arm A, 7.7 months for Arm B, and 8.0 months for Arm C).
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
|
General disorders
Chest discomfort
|
0.00%
0/39 • All-cause mortality was assessed through the end of study, February 26th, 2024 (maximum time on study was 12 months). Adverse events were assessed from the first dose of study drug to 30 days after the last dose or the start of new anticancer therapy, whichever occurred first (maximum time on treatment was 8.9 months for Arm A, 7.7 months for Arm B, and 8.0 months for Arm C).
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
0.00%
0/19 • All-cause mortality was assessed through the end of study, February 26th, 2024 (maximum time on study was 12 months). Adverse events were assessed from the first dose of study drug to 30 days after the last dose or the start of new anticancer therapy, whichever occurred first (maximum time on treatment was 8.9 months for Arm A, 7.7 months for Arm B, and 8.0 months for Arm C).
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
2.9%
1/34 • Number of events 1 • All-cause mortality was assessed through the end of study, February 26th, 2024 (maximum time on study was 12 months). Adverse events were assessed from the first dose of study drug to 30 days after the last dose or the start of new anticancer therapy, whichever occurred first (maximum time on treatment was 8.9 months for Arm A, 7.7 months for Arm B, and 8.0 months for Arm C).
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
|
General disorders
Chest pain
|
0.00%
0/39 • All-cause mortality was assessed through the end of study, February 26th, 2024 (maximum time on study was 12 months). Adverse events were assessed from the first dose of study drug to 30 days after the last dose or the start of new anticancer therapy, whichever occurred first (maximum time on treatment was 8.9 months for Arm A, 7.7 months for Arm B, and 8.0 months for Arm C).
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
5.3%
1/19 • Number of events 1 • All-cause mortality was assessed through the end of study, February 26th, 2024 (maximum time on study was 12 months). Adverse events were assessed from the first dose of study drug to 30 days after the last dose or the start of new anticancer therapy, whichever occurred first (maximum time on treatment was 8.9 months for Arm A, 7.7 months for Arm B, and 8.0 months for Arm C).
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
0.00%
0/34 • All-cause mortality was assessed through the end of study, February 26th, 2024 (maximum time on study was 12 months). Adverse events were assessed from the first dose of study drug to 30 days after the last dose or the start of new anticancer therapy, whichever occurred first (maximum time on treatment was 8.9 months for Arm A, 7.7 months for Arm B, and 8.0 months for Arm C).
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
|
General disorders
Death
|
12.8%
5/39 • Number of events 5 • All-cause mortality was assessed through the end of study, February 26th, 2024 (maximum time on study was 12 months). Adverse events were assessed from the first dose of study drug to 30 days after the last dose or the start of new anticancer therapy, whichever occurred first (maximum time on treatment was 8.9 months for Arm A, 7.7 months for Arm B, and 8.0 months for Arm C).
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
0.00%
0/19 • All-cause mortality was assessed through the end of study, February 26th, 2024 (maximum time on study was 12 months). Adverse events were assessed from the first dose of study drug to 30 days after the last dose or the start of new anticancer therapy, whichever occurred first (maximum time on treatment was 8.9 months for Arm A, 7.7 months for Arm B, and 8.0 months for Arm C).
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
5.9%
2/34 • Number of events 2 • All-cause mortality was assessed through the end of study, February 26th, 2024 (maximum time on study was 12 months). Adverse events were assessed from the first dose of study drug to 30 days after the last dose or the start of new anticancer therapy, whichever occurred first (maximum time on treatment was 8.9 months for Arm A, 7.7 months for Arm B, and 8.0 months for Arm C).
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
|
General disorders
Malaise
|
0.00%
0/39 • All-cause mortality was assessed through the end of study, February 26th, 2024 (maximum time on study was 12 months). Adverse events were assessed from the first dose of study drug to 30 days after the last dose or the start of new anticancer therapy, whichever occurred first (maximum time on treatment was 8.9 months for Arm A, 7.7 months for Arm B, and 8.0 months for Arm C).
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
0.00%
0/19 • All-cause mortality was assessed through the end of study, February 26th, 2024 (maximum time on study was 12 months). Adverse events were assessed from the first dose of study drug to 30 days after the last dose or the start of new anticancer therapy, whichever occurred first (maximum time on treatment was 8.9 months for Arm A, 7.7 months for Arm B, and 8.0 months for Arm C).
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
2.9%
1/34 • Number of events 1 • All-cause mortality was assessed through the end of study, February 26th, 2024 (maximum time on study was 12 months). Adverse events were assessed from the first dose of study drug to 30 days after the last dose or the start of new anticancer therapy, whichever occurred first (maximum time on treatment was 8.9 months for Arm A, 7.7 months for Arm B, and 8.0 months for Arm C).
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
|
General disorders
Multiple organ dysfunction syndrome
|
2.6%
1/39 • Number of events 1 • All-cause mortality was assessed through the end of study, February 26th, 2024 (maximum time on study was 12 months). Adverse events were assessed from the first dose of study drug to 30 days after the last dose or the start of new anticancer therapy, whichever occurred first (maximum time on treatment was 8.9 months for Arm A, 7.7 months for Arm B, and 8.0 months for Arm C).
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
0.00%
0/19 • All-cause mortality was assessed through the end of study, February 26th, 2024 (maximum time on study was 12 months). Adverse events were assessed from the first dose of study drug to 30 days after the last dose or the start of new anticancer therapy, whichever occurred first (maximum time on treatment was 8.9 months for Arm A, 7.7 months for Arm B, and 8.0 months for Arm C).
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
0.00%
0/34 • All-cause mortality was assessed through the end of study, February 26th, 2024 (maximum time on study was 12 months). Adverse events were assessed from the first dose of study drug to 30 days after the last dose or the start of new anticancer therapy, whichever occurred first (maximum time on treatment was 8.9 months for Arm A, 7.7 months for Arm B, and 8.0 months for Arm C).
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
|
Hepatobiliary disorders
Hepatic failure
|
2.6%
1/39 • Number of events 1 • All-cause mortality was assessed through the end of study, February 26th, 2024 (maximum time on study was 12 months). Adverse events were assessed from the first dose of study drug to 30 days after the last dose or the start of new anticancer therapy, whichever occurred first (maximum time on treatment was 8.9 months for Arm A, 7.7 months for Arm B, and 8.0 months for Arm C).
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
0.00%
0/19 • All-cause mortality was assessed through the end of study, February 26th, 2024 (maximum time on study was 12 months). Adverse events were assessed from the first dose of study drug to 30 days after the last dose or the start of new anticancer therapy, whichever occurred first (maximum time on treatment was 8.9 months for Arm A, 7.7 months for Arm B, and 8.0 months for Arm C).
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
0.00%
0/34 • All-cause mortality was assessed through the end of study, February 26th, 2024 (maximum time on study was 12 months). Adverse events were assessed from the first dose of study drug to 30 days after the last dose or the start of new anticancer therapy, whichever occurred first (maximum time on treatment was 8.9 months for Arm A, 7.7 months for Arm B, and 8.0 months for Arm C).
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
|
Infections and infestations
Bacteraemia
|
0.00%
0/39 • All-cause mortality was assessed through the end of study, February 26th, 2024 (maximum time on study was 12 months). Adverse events were assessed from the first dose of study drug to 30 days after the last dose or the start of new anticancer therapy, whichever occurred first (maximum time on treatment was 8.9 months for Arm A, 7.7 months for Arm B, and 8.0 months for Arm C).
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
0.00%
0/19 • All-cause mortality was assessed through the end of study, February 26th, 2024 (maximum time on study was 12 months). Adverse events were assessed from the first dose of study drug to 30 days after the last dose or the start of new anticancer therapy, whichever occurred first (maximum time on treatment was 8.9 months for Arm A, 7.7 months for Arm B, and 8.0 months for Arm C).
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
2.9%
1/34 • Number of events 1 • All-cause mortality was assessed through the end of study, February 26th, 2024 (maximum time on study was 12 months). Adverse events were assessed from the first dose of study drug to 30 days after the last dose or the start of new anticancer therapy, whichever occurred first (maximum time on treatment was 8.9 months for Arm A, 7.7 months for Arm B, and 8.0 months for Arm C).
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
|
Infections and infestations
COVID-19
|
0.00%
0/39 • All-cause mortality was assessed through the end of study, February 26th, 2024 (maximum time on study was 12 months). Adverse events were assessed from the first dose of study drug to 30 days after the last dose or the start of new anticancer therapy, whichever occurred first (maximum time on treatment was 8.9 months for Arm A, 7.7 months for Arm B, and 8.0 months for Arm C).
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
0.00%
0/19 • All-cause mortality was assessed through the end of study, February 26th, 2024 (maximum time on study was 12 months). Adverse events were assessed from the first dose of study drug to 30 days after the last dose or the start of new anticancer therapy, whichever occurred first (maximum time on treatment was 8.9 months for Arm A, 7.7 months for Arm B, and 8.0 months for Arm C).
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
2.9%
1/34 • Number of events 1 • All-cause mortality was assessed through the end of study, February 26th, 2024 (maximum time on study was 12 months). Adverse events were assessed from the first dose of study drug to 30 days after the last dose or the start of new anticancer therapy, whichever occurred first (maximum time on treatment was 8.9 months for Arm A, 7.7 months for Arm B, and 8.0 months for Arm C).
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
|
Infections and infestations
COVID-19 pneumonia
|
5.1%
2/39 • Number of events 2 • All-cause mortality was assessed through the end of study, February 26th, 2024 (maximum time on study was 12 months). Adverse events were assessed from the first dose of study drug to 30 days after the last dose or the start of new anticancer therapy, whichever occurred first (maximum time on treatment was 8.9 months for Arm A, 7.7 months for Arm B, and 8.0 months for Arm C).
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
5.3%
1/19 • Number of events 1 • All-cause mortality was assessed through the end of study, February 26th, 2024 (maximum time on study was 12 months). Adverse events were assessed from the first dose of study drug to 30 days after the last dose or the start of new anticancer therapy, whichever occurred first (maximum time on treatment was 8.9 months for Arm A, 7.7 months for Arm B, and 8.0 months for Arm C).
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
2.9%
1/34 • Number of events 1 • All-cause mortality was assessed through the end of study, February 26th, 2024 (maximum time on study was 12 months). Adverse events were assessed from the first dose of study drug to 30 days after the last dose or the start of new anticancer therapy, whichever occurred first (maximum time on treatment was 8.9 months for Arm A, 7.7 months for Arm B, and 8.0 months for Arm C).
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
|
Infections and infestations
Pneumonia
|
7.7%
3/39 • Number of events 3 • All-cause mortality was assessed through the end of study, February 26th, 2024 (maximum time on study was 12 months). Adverse events were assessed from the first dose of study drug to 30 days after the last dose or the start of new anticancer therapy, whichever occurred first (maximum time on treatment was 8.9 months for Arm A, 7.7 months for Arm B, and 8.0 months for Arm C).
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
5.3%
1/19 • Number of events 1 • All-cause mortality was assessed through the end of study, February 26th, 2024 (maximum time on study was 12 months). Adverse events were assessed from the first dose of study drug to 30 days after the last dose or the start of new anticancer therapy, whichever occurred first (maximum time on treatment was 8.9 months for Arm A, 7.7 months for Arm B, and 8.0 months for Arm C).
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
5.9%
2/34 • Number of events 2 • All-cause mortality was assessed through the end of study, February 26th, 2024 (maximum time on study was 12 months). Adverse events were assessed from the first dose of study drug to 30 days after the last dose or the start of new anticancer therapy, whichever occurred first (maximum time on treatment was 8.9 months for Arm A, 7.7 months for Arm B, and 8.0 months for Arm C).
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
|
Infections and infestations
Pneumonia bacterial
|
2.6%
1/39 • Number of events 1 • All-cause mortality was assessed through the end of study, February 26th, 2024 (maximum time on study was 12 months). Adverse events were assessed from the first dose of study drug to 30 days after the last dose or the start of new anticancer therapy, whichever occurred first (maximum time on treatment was 8.9 months for Arm A, 7.7 months for Arm B, and 8.0 months for Arm C).
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
0.00%
0/19 • All-cause mortality was assessed through the end of study, February 26th, 2024 (maximum time on study was 12 months). Adverse events were assessed from the first dose of study drug to 30 days after the last dose or the start of new anticancer therapy, whichever occurred first (maximum time on treatment was 8.9 months for Arm A, 7.7 months for Arm B, and 8.0 months for Arm C).
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
2.9%
1/34 • Number of events 1 • All-cause mortality was assessed through the end of study, February 26th, 2024 (maximum time on study was 12 months). Adverse events were assessed from the first dose of study drug to 30 days after the last dose or the start of new anticancer therapy, whichever occurred first (maximum time on treatment was 8.9 months for Arm A, 7.7 months for Arm B, and 8.0 months for Arm C).
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
|
Infections and infestations
Pneumonia fungal
|
2.6%
1/39 • Number of events 1 • All-cause mortality was assessed through the end of study, February 26th, 2024 (maximum time on study was 12 months). Adverse events were assessed from the first dose of study drug to 30 days after the last dose or the start of new anticancer therapy, whichever occurred first (maximum time on treatment was 8.9 months for Arm A, 7.7 months for Arm B, and 8.0 months for Arm C).
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
0.00%
0/19 • All-cause mortality was assessed through the end of study, February 26th, 2024 (maximum time on study was 12 months). Adverse events were assessed from the first dose of study drug to 30 days after the last dose or the start of new anticancer therapy, whichever occurred first (maximum time on treatment was 8.9 months for Arm A, 7.7 months for Arm B, and 8.0 months for Arm C).
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
0.00%
0/34 • All-cause mortality was assessed through the end of study, February 26th, 2024 (maximum time on study was 12 months). Adverse events were assessed from the first dose of study drug to 30 days after the last dose or the start of new anticancer therapy, whichever occurred first (maximum time on treatment was 8.9 months for Arm A, 7.7 months for Arm B, and 8.0 months for Arm C).
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
|
Infections and infestations
Postoperative wound infection
|
2.6%
1/39 • Number of events 1 • All-cause mortality was assessed through the end of study, February 26th, 2024 (maximum time on study was 12 months). Adverse events were assessed from the first dose of study drug to 30 days after the last dose or the start of new anticancer therapy, whichever occurred first (maximum time on treatment was 8.9 months for Arm A, 7.7 months for Arm B, and 8.0 months for Arm C).
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
0.00%
0/19 • All-cause mortality was assessed through the end of study, February 26th, 2024 (maximum time on study was 12 months). Adverse events were assessed from the first dose of study drug to 30 days after the last dose or the start of new anticancer therapy, whichever occurred first (maximum time on treatment was 8.9 months for Arm A, 7.7 months for Arm B, and 8.0 months for Arm C).
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
0.00%
0/34 • All-cause mortality was assessed through the end of study, February 26th, 2024 (maximum time on study was 12 months). Adverse events were assessed from the first dose of study drug to 30 days after the last dose or the start of new anticancer therapy, whichever occurred first (maximum time on treatment was 8.9 months for Arm A, 7.7 months for Arm B, and 8.0 months for Arm C).
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
|
Infections and infestations
Septic shock
|
2.6%
1/39 • Number of events 1 • All-cause mortality was assessed through the end of study, February 26th, 2024 (maximum time on study was 12 months). Adverse events were assessed from the first dose of study drug to 30 days after the last dose or the start of new anticancer therapy, whichever occurred first (maximum time on treatment was 8.9 months for Arm A, 7.7 months for Arm B, and 8.0 months for Arm C).
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
0.00%
0/19 • All-cause mortality was assessed through the end of study, February 26th, 2024 (maximum time on study was 12 months). Adverse events were assessed from the first dose of study drug to 30 days after the last dose or the start of new anticancer therapy, whichever occurred first (maximum time on treatment was 8.9 months for Arm A, 7.7 months for Arm B, and 8.0 months for Arm C).
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
0.00%
0/34 • All-cause mortality was assessed through the end of study, February 26th, 2024 (maximum time on study was 12 months). Adverse events were assessed from the first dose of study drug to 30 days after the last dose or the start of new anticancer therapy, whichever occurred first (maximum time on treatment was 8.9 months for Arm A, 7.7 months for Arm B, and 8.0 months for Arm C).
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
|
Infections and infestations
Skin infection
|
0.00%
0/39 • All-cause mortality was assessed through the end of study, February 26th, 2024 (maximum time on study was 12 months). Adverse events were assessed from the first dose of study drug to 30 days after the last dose or the start of new anticancer therapy, whichever occurred first (maximum time on treatment was 8.9 months for Arm A, 7.7 months for Arm B, and 8.0 months for Arm C).
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
5.3%
1/19 • Number of events 1 • All-cause mortality was assessed through the end of study, February 26th, 2024 (maximum time on study was 12 months). Adverse events were assessed from the first dose of study drug to 30 days after the last dose or the start of new anticancer therapy, whichever occurred first (maximum time on treatment was 8.9 months for Arm A, 7.7 months for Arm B, and 8.0 months for Arm C).
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
0.00%
0/34 • All-cause mortality was assessed through the end of study, February 26th, 2024 (maximum time on study was 12 months). Adverse events were assessed from the first dose of study drug to 30 days after the last dose or the start of new anticancer therapy, whichever occurred first (maximum time on treatment was 8.9 months for Arm A, 7.7 months for Arm B, and 8.0 months for Arm C).
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
|
Infections and infestations
Subcutaneous abscess
|
2.6%
1/39 • Number of events 1 • All-cause mortality was assessed through the end of study, February 26th, 2024 (maximum time on study was 12 months). Adverse events were assessed from the first dose of study drug to 30 days after the last dose or the start of new anticancer therapy, whichever occurred first (maximum time on treatment was 8.9 months for Arm A, 7.7 months for Arm B, and 8.0 months for Arm C).
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
0.00%
0/19 • All-cause mortality was assessed through the end of study, February 26th, 2024 (maximum time on study was 12 months). Adverse events were assessed from the first dose of study drug to 30 days after the last dose or the start of new anticancer therapy, whichever occurred first (maximum time on treatment was 8.9 months for Arm A, 7.7 months for Arm B, and 8.0 months for Arm C).
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
0.00%
0/34 • All-cause mortality was assessed through the end of study, February 26th, 2024 (maximum time on study was 12 months). Adverse events were assessed from the first dose of study drug to 30 days after the last dose or the start of new anticancer therapy, whichever occurred first (maximum time on treatment was 8.9 months for Arm A, 7.7 months for Arm B, and 8.0 months for Arm C).
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/39 • All-cause mortality was assessed through the end of study, February 26th, 2024 (maximum time on study was 12 months). Adverse events were assessed from the first dose of study drug to 30 days after the last dose or the start of new anticancer therapy, whichever occurred first (maximum time on treatment was 8.9 months for Arm A, 7.7 months for Arm B, and 8.0 months for Arm C).
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
5.3%
1/19 • Number of events 1 • All-cause mortality was assessed through the end of study, February 26th, 2024 (maximum time on study was 12 months). Adverse events were assessed from the first dose of study drug to 30 days after the last dose or the start of new anticancer therapy, whichever occurred first (maximum time on treatment was 8.9 months for Arm A, 7.7 months for Arm B, and 8.0 months for Arm C).
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
0.00%
0/34 • All-cause mortality was assessed through the end of study, February 26th, 2024 (maximum time on study was 12 months). Adverse events were assessed from the first dose of study drug to 30 days after the last dose or the start of new anticancer therapy, whichever occurred first (maximum time on treatment was 8.9 months for Arm A, 7.7 months for Arm B, and 8.0 months for Arm C).
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
|
Injury, poisoning and procedural complications
Radiation pneumonitis
|
2.6%
1/39 • Number of events 1 • All-cause mortality was assessed through the end of study, February 26th, 2024 (maximum time on study was 12 months). Adverse events were assessed from the first dose of study drug to 30 days after the last dose or the start of new anticancer therapy, whichever occurred first (maximum time on treatment was 8.9 months for Arm A, 7.7 months for Arm B, and 8.0 months for Arm C).
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
0.00%
0/19 • All-cause mortality was assessed through the end of study, February 26th, 2024 (maximum time on study was 12 months). Adverse events were assessed from the first dose of study drug to 30 days after the last dose or the start of new anticancer therapy, whichever occurred first (maximum time on treatment was 8.9 months for Arm A, 7.7 months for Arm B, and 8.0 months for Arm C).
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
0.00%
0/34 • All-cause mortality was assessed through the end of study, February 26th, 2024 (maximum time on study was 12 months). Adverse events were assessed from the first dose of study drug to 30 days after the last dose or the start of new anticancer therapy, whichever occurred first (maximum time on treatment was 8.9 months for Arm A, 7.7 months for Arm B, and 8.0 months for Arm C).
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
|
Investigations
Aspartate aminotransferase increased
|
2.6%
1/39 • Number of events 1 • All-cause mortality was assessed through the end of study, February 26th, 2024 (maximum time on study was 12 months). Adverse events were assessed from the first dose of study drug to 30 days after the last dose or the start of new anticancer therapy, whichever occurred first (maximum time on treatment was 8.9 months for Arm A, 7.7 months for Arm B, and 8.0 months for Arm C).
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
0.00%
0/19 • All-cause mortality was assessed through the end of study, February 26th, 2024 (maximum time on study was 12 months). Adverse events were assessed from the first dose of study drug to 30 days after the last dose or the start of new anticancer therapy, whichever occurred first (maximum time on treatment was 8.9 months for Arm A, 7.7 months for Arm B, and 8.0 months for Arm C).
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
0.00%
0/34 • All-cause mortality was assessed through the end of study, February 26th, 2024 (maximum time on study was 12 months). Adverse events were assessed from the first dose of study drug to 30 days after the last dose or the start of new anticancer therapy, whichever occurred first (maximum time on treatment was 8.9 months for Arm A, 7.7 months for Arm B, and 8.0 months for Arm C).
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
|
Investigations
Neutrophil count decreased
|
0.00%
0/39 • All-cause mortality was assessed through the end of study, February 26th, 2024 (maximum time on study was 12 months). Adverse events were assessed from the first dose of study drug to 30 days after the last dose or the start of new anticancer therapy, whichever occurred first (maximum time on treatment was 8.9 months for Arm A, 7.7 months for Arm B, and 8.0 months for Arm C).
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
0.00%
0/19 • All-cause mortality was assessed through the end of study, February 26th, 2024 (maximum time on study was 12 months). Adverse events were assessed from the first dose of study drug to 30 days after the last dose or the start of new anticancer therapy, whichever occurred first (maximum time on treatment was 8.9 months for Arm A, 7.7 months for Arm B, and 8.0 months for Arm C).
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
8.8%
3/34 • Number of events 3 • All-cause mortality was assessed through the end of study, February 26th, 2024 (maximum time on study was 12 months). Adverse events were assessed from the first dose of study drug to 30 days after the last dose or the start of new anticancer therapy, whichever occurred first (maximum time on treatment was 8.9 months for Arm A, 7.7 months for Arm B, and 8.0 months for Arm C).
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
|
Investigations
White blood cell count decreased
|
0.00%
0/39 • All-cause mortality was assessed through the end of study, February 26th, 2024 (maximum time on study was 12 months). Adverse events were assessed from the first dose of study drug to 30 days after the last dose or the start of new anticancer therapy, whichever occurred first (maximum time on treatment was 8.9 months for Arm A, 7.7 months for Arm B, and 8.0 months for Arm C).
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
0.00%
0/19 • All-cause mortality was assessed through the end of study, February 26th, 2024 (maximum time on study was 12 months). Adverse events were assessed from the first dose of study drug to 30 days after the last dose or the start of new anticancer therapy, whichever occurred first (maximum time on treatment was 8.9 months for Arm A, 7.7 months for Arm B, and 8.0 months for Arm C).
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
8.8%
3/34 • Number of events 3 • All-cause mortality was assessed through the end of study, February 26th, 2024 (maximum time on study was 12 months). Adverse events were assessed from the first dose of study drug to 30 days after the last dose or the start of new anticancer therapy, whichever occurred first (maximum time on treatment was 8.9 months for Arm A, 7.7 months for Arm B, and 8.0 months for Arm C).
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
|
Metabolism and nutrition disorders
Cachexia
|
0.00%
0/39 • All-cause mortality was assessed through the end of study, February 26th, 2024 (maximum time on study was 12 months). Adverse events were assessed from the first dose of study drug to 30 days after the last dose or the start of new anticancer therapy, whichever occurred first (maximum time on treatment was 8.9 months for Arm A, 7.7 months for Arm B, and 8.0 months for Arm C).
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
0.00%
0/19 • All-cause mortality was assessed through the end of study, February 26th, 2024 (maximum time on study was 12 months). Adverse events were assessed from the first dose of study drug to 30 days after the last dose or the start of new anticancer therapy, whichever occurred first (maximum time on treatment was 8.9 months for Arm A, 7.7 months for Arm B, and 8.0 months for Arm C).
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
2.9%
1/34 • Number of events 1 • All-cause mortality was assessed through the end of study, February 26th, 2024 (maximum time on study was 12 months). Adverse events were assessed from the first dose of study drug to 30 days after the last dose or the start of new anticancer therapy, whichever occurred first (maximum time on treatment was 8.9 months for Arm A, 7.7 months for Arm B, and 8.0 months for Arm C).
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
2.6%
1/39 • Number of events 1 • All-cause mortality was assessed through the end of study, February 26th, 2024 (maximum time on study was 12 months). Adverse events were assessed from the first dose of study drug to 30 days after the last dose or the start of new anticancer therapy, whichever occurred first (maximum time on treatment was 8.9 months for Arm A, 7.7 months for Arm B, and 8.0 months for Arm C).
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
0.00%
0/19 • All-cause mortality was assessed through the end of study, February 26th, 2024 (maximum time on study was 12 months). Adverse events were assessed from the first dose of study drug to 30 days after the last dose or the start of new anticancer therapy, whichever occurred first (maximum time on treatment was 8.9 months for Arm A, 7.7 months for Arm B, and 8.0 months for Arm C).
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
0.00%
0/34 • All-cause mortality was assessed through the end of study, February 26th, 2024 (maximum time on study was 12 months). Adverse events were assessed from the first dose of study drug to 30 days after the last dose or the start of new anticancer therapy, whichever occurred first (maximum time on treatment was 8.9 months for Arm A, 7.7 months for Arm B, and 8.0 months for Arm C).
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
|
Metabolism and nutrition disorders
Electrolyte imbalance
|
2.6%
1/39 • Number of events 1 • All-cause mortality was assessed through the end of study, February 26th, 2024 (maximum time on study was 12 months). Adverse events were assessed from the first dose of study drug to 30 days after the last dose or the start of new anticancer therapy, whichever occurred first (maximum time on treatment was 8.9 months for Arm A, 7.7 months for Arm B, and 8.0 months for Arm C).
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
0.00%
0/19 • All-cause mortality was assessed through the end of study, February 26th, 2024 (maximum time on study was 12 months). Adverse events were assessed from the first dose of study drug to 30 days after the last dose or the start of new anticancer therapy, whichever occurred first (maximum time on treatment was 8.9 months for Arm A, 7.7 months for Arm B, and 8.0 months for Arm C).
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
0.00%
0/34 • All-cause mortality was assessed through the end of study, February 26th, 2024 (maximum time on study was 12 months). Adverse events were assessed from the first dose of study drug to 30 days after the last dose or the start of new anticancer therapy, whichever occurred first (maximum time on treatment was 8.9 months for Arm A, 7.7 months for Arm B, and 8.0 months for Arm C).
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
5.1%
2/39 • Number of events 2 • All-cause mortality was assessed through the end of study, February 26th, 2024 (maximum time on study was 12 months). Adverse events were assessed from the first dose of study drug to 30 days after the last dose or the start of new anticancer therapy, whichever occurred first (maximum time on treatment was 8.9 months for Arm A, 7.7 months for Arm B, and 8.0 months for Arm C).
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
0.00%
0/19 • All-cause mortality was assessed through the end of study, February 26th, 2024 (maximum time on study was 12 months). Adverse events were assessed from the first dose of study drug to 30 days after the last dose or the start of new anticancer therapy, whichever occurred first (maximum time on treatment was 8.9 months for Arm A, 7.7 months for Arm B, and 8.0 months for Arm C).
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
2.9%
1/34 • Number of events 1 • All-cause mortality was assessed through the end of study, February 26th, 2024 (maximum time on study was 12 months). Adverse events were assessed from the first dose of study drug to 30 days after the last dose or the start of new anticancer therapy, whichever occurred first (maximum time on treatment was 8.9 months for Arm A, 7.7 months for Arm B, and 8.0 months for Arm C).
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cancer pain
|
0.00%
0/39 • All-cause mortality was assessed through the end of study, February 26th, 2024 (maximum time on study was 12 months). Adverse events were assessed from the first dose of study drug to 30 days after the last dose or the start of new anticancer therapy, whichever occurred first (maximum time on treatment was 8.9 months for Arm A, 7.7 months for Arm B, and 8.0 months for Arm C).
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
0.00%
0/19 • All-cause mortality was assessed through the end of study, February 26th, 2024 (maximum time on study was 12 months). Adverse events were assessed from the first dose of study drug to 30 days after the last dose or the start of new anticancer therapy, whichever occurred first (maximum time on treatment was 8.9 months for Arm A, 7.7 months for Arm B, and 8.0 months for Arm C).
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
2.9%
1/34 • Number of events 1 • All-cause mortality was assessed through the end of study, February 26th, 2024 (maximum time on study was 12 months). Adverse events were assessed from the first dose of study drug to 30 days after the last dose or the start of new anticancer therapy, whichever occurred first (maximum time on treatment was 8.9 months for Arm A, 7.7 months for Arm B, and 8.0 months for Arm C).
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to soft tissue
|
2.6%
1/39 • Number of events 1 • All-cause mortality was assessed through the end of study, February 26th, 2024 (maximum time on study was 12 months). Adverse events were assessed from the first dose of study drug to 30 days after the last dose or the start of new anticancer therapy, whichever occurred first (maximum time on treatment was 8.9 months for Arm A, 7.7 months for Arm B, and 8.0 months for Arm C).
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
0.00%
0/19 • All-cause mortality was assessed through the end of study, February 26th, 2024 (maximum time on study was 12 months). Adverse events were assessed from the first dose of study drug to 30 days after the last dose or the start of new anticancer therapy, whichever occurred first (maximum time on treatment was 8.9 months for Arm A, 7.7 months for Arm B, and 8.0 months for Arm C).
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
0.00%
0/34 • All-cause mortality was assessed through the end of study, February 26th, 2024 (maximum time on study was 12 months). Adverse events were assessed from the first dose of study drug to 30 days after the last dose or the start of new anticancer therapy, whichever occurred first (maximum time on treatment was 8.9 months for Arm A, 7.7 months for Arm B, and 8.0 months for Arm C).
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour haemorrhage
|
2.6%
1/39 • Number of events 1 • All-cause mortality was assessed through the end of study, February 26th, 2024 (maximum time on study was 12 months). Adverse events were assessed from the first dose of study drug to 30 days after the last dose or the start of new anticancer therapy, whichever occurred first (maximum time on treatment was 8.9 months for Arm A, 7.7 months for Arm B, and 8.0 months for Arm C).
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
0.00%
0/19 • All-cause mortality was assessed through the end of study, February 26th, 2024 (maximum time on study was 12 months). Adverse events were assessed from the first dose of study drug to 30 days after the last dose or the start of new anticancer therapy, whichever occurred first (maximum time on treatment was 8.9 months for Arm A, 7.7 months for Arm B, and 8.0 months for Arm C).
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
0.00%
0/34 • All-cause mortality was assessed through the end of study, February 26th, 2024 (maximum time on study was 12 months). Adverse events were assessed from the first dose of study drug to 30 days after the last dose or the start of new anticancer therapy, whichever occurred first (maximum time on treatment was 8.9 months for Arm A, 7.7 months for Arm B, and 8.0 months for Arm C).
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
|
Nervous system disorders
Hepatic encephalopathy
|
2.6%
1/39 • Number of events 1 • All-cause mortality was assessed through the end of study, February 26th, 2024 (maximum time on study was 12 months). Adverse events were assessed from the first dose of study drug to 30 days after the last dose or the start of new anticancer therapy, whichever occurred first (maximum time on treatment was 8.9 months for Arm A, 7.7 months for Arm B, and 8.0 months for Arm C).
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
0.00%
0/19 • All-cause mortality was assessed through the end of study, February 26th, 2024 (maximum time on study was 12 months). Adverse events were assessed from the first dose of study drug to 30 days after the last dose or the start of new anticancer therapy, whichever occurred first (maximum time on treatment was 8.9 months for Arm A, 7.7 months for Arm B, and 8.0 months for Arm C).
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
0.00%
0/34 • All-cause mortality was assessed through the end of study, February 26th, 2024 (maximum time on study was 12 months). Adverse events were assessed from the first dose of study drug to 30 days after the last dose or the start of new anticancer therapy, whichever occurred first (maximum time on treatment was 8.9 months for Arm A, 7.7 months for Arm B, and 8.0 months for Arm C).
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
|
Nervous system disorders
Hypoaesthesia
|
2.6%
1/39 • Number of events 1 • All-cause mortality was assessed through the end of study, February 26th, 2024 (maximum time on study was 12 months). Adverse events were assessed from the first dose of study drug to 30 days after the last dose or the start of new anticancer therapy, whichever occurred first (maximum time on treatment was 8.9 months for Arm A, 7.7 months for Arm B, and 8.0 months for Arm C).
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
0.00%
0/19 • All-cause mortality was assessed through the end of study, February 26th, 2024 (maximum time on study was 12 months). Adverse events were assessed from the first dose of study drug to 30 days after the last dose or the start of new anticancer therapy, whichever occurred first (maximum time on treatment was 8.9 months for Arm A, 7.7 months for Arm B, and 8.0 months for Arm C).
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
0.00%
0/34 • All-cause mortality was assessed through the end of study, February 26th, 2024 (maximum time on study was 12 months). Adverse events were assessed from the first dose of study drug to 30 days after the last dose or the start of new anticancer therapy, whichever occurred first (maximum time on treatment was 8.9 months for Arm A, 7.7 months for Arm B, and 8.0 months for Arm C).
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
|
Nervous system disorders
Loss of consciousness
|
0.00%
0/39 • All-cause mortality was assessed through the end of study, February 26th, 2024 (maximum time on study was 12 months). Adverse events were assessed from the first dose of study drug to 30 days after the last dose or the start of new anticancer therapy, whichever occurred first (maximum time on treatment was 8.9 months for Arm A, 7.7 months for Arm B, and 8.0 months for Arm C).
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
5.3%
1/19 • Number of events 1 • All-cause mortality was assessed through the end of study, February 26th, 2024 (maximum time on study was 12 months). Adverse events were assessed from the first dose of study drug to 30 days after the last dose or the start of new anticancer therapy, whichever occurred first (maximum time on treatment was 8.9 months for Arm A, 7.7 months for Arm B, and 8.0 months for Arm C).
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
0.00%
0/34 • All-cause mortality was assessed through the end of study, February 26th, 2024 (maximum time on study was 12 months). Adverse events were assessed from the first dose of study drug to 30 days after the last dose or the start of new anticancer therapy, whichever occurred first (maximum time on treatment was 8.9 months for Arm A, 7.7 months for Arm B, and 8.0 months for Arm C).
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Acquired tracheo-oesophageal fistula
|
5.1%
2/39 • Number of events 2 • All-cause mortality was assessed through the end of study, February 26th, 2024 (maximum time on study was 12 months). Adverse events were assessed from the first dose of study drug to 30 days after the last dose or the start of new anticancer therapy, whichever occurred first (maximum time on treatment was 8.9 months for Arm A, 7.7 months for Arm B, and 8.0 months for Arm C).
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
0.00%
0/19 • All-cause mortality was assessed through the end of study, February 26th, 2024 (maximum time on study was 12 months). Adverse events were assessed from the first dose of study drug to 30 days after the last dose or the start of new anticancer therapy, whichever occurred first (maximum time on treatment was 8.9 months for Arm A, 7.7 months for Arm B, and 8.0 months for Arm C).
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
0.00%
0/34 • All-cause mortality was assessed through the end of study, February 26th, 2024 (maximum time on study was 12 months). Adverse events were assessed from the first dose of study drug to 30 days after the last dose or the start of new anticancer therapy, whichever occurred first (maximum time on treatment was 8.9 months for Arm A, 7.7 months for Arm B, and 8.0 months for Arm C).
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
2.6%
1/39 • Number of events 1 • All-cause mortality was assessed through the end of study, February 26th, 2024 (maximum time on study was 12 months). Adverse events were assessed from the first dose of study drug to 30 days after the last dose or the start of new anticancer therapy, whichever occurred first (maximum time on treatment was 8.9 months for Arm A, 7.7 months for Arm B, and 8.0 months for Arm C).
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
0.00%
0/19 • All-cause mortality was assessed through the end of study, February 26th, 2024 (maximum time on study was 12 months). Adverse events were assessed from the first dose of study drug to 30 days after the last dose or the start of new anticancer therapy, whichever occurred first (maximum time on treatment was 8.9 months for Arm A, 7.7 months for Arm B, and 8.0 months for Arm C).
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
0.00%
0/34 • All-cause mortality was assessed through the end of study, February 26th, 2024 (maximum time on study was 12 months). Adverse events were assessed from the first dose of study drug to 30 days after the last dose or the start of new anticancer therapy, whichever occurred first (maximum time on treatment was 8.9 months for Arm A, 7.7 months for Arm B, and 8.0 months for Arm C).
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.00%
0/39 • All-cause mortality was assessed through the end of study, February 26th, 2024 (maximum time on study was 12 months). Adverse events were assessed from the first dose of study drug to 30 days after the last dose or the start of new anticancer therapy, whichever occurred first (maximum time on treatment was 8.9 months for Arm A, 7.7 months for Arm B, and 8.0 months for Arm C).
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
0.00%
0/19 • All-cause mortality was assessed through the end of study, February 26th, 2024 (maximum time on study was 12 months). Adverse events were assessed from the first dose of study drug to 30 days after the last dose or the start of new anticancer therapy, whichever occurred first (maximum time on treatment was 8.9 months for Arm A, 7.7 months for Arm B, and 8.0 months for Arm C).
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
2.9%
1/34 • Number of events 1 • All-cause mortality was assessed through the end of study, February 26th, 2024 (maximum time on study was 12 months). Adverse events were assessed from the first dose of study drug to 30 days after the last dose or the start of new anticancer therapy, whichever occurred first (maximum time on treatment was 8.9 months for Arm A, 7.7 months for Arm B, and 8.0 months for Arm C).
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchial fistula
|
2.6%
1/39 • Number of events 1 • All-cause mortality was assessed through the end of study, February 26th, 2024 (maximum time on study was 12 months). Adverse events were assessed from the first dose of study drug to 30 days after the last dose or the start of new anticancer therapy, whichever occurred first (maximum time on treatment was 8.9 months for Arm A, 7.7 months for Arm B, and 8.0 months for Arm C).
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
0.00%
0/19 • All-cause mortality was assessed through the end of study, February 26th, 2024 (maximum time on study was 12 months). Adverse events were assessed from the first dose of study drug to 30 days after the last dose or the start of new anticancer therapy, whichever occurred first (maximum time on treatment was 8.9 months for Arm A, 7.7 months for Arm B, and 8.0 months for Arm C).
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
0.00%
0/34 • All-cause mortality was assessed through the end of study, February 26th, 2024 (maximum time on study was 12 months). Adverse events were assessed from the first dose of study drug to 30 days after the last dose or the start of new anticancer therapy, whichever occurred first (maximum time on treatment was 8.9 months for Arm A, 7.7 months for Arm B, and 8.0 months for Arm C).
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/39 • All-cause mortality was assessed through the end of study, February 26th, 2024 (maximum time on study was 12 months). Adverse events were assessed from the first dose of study drug to 30 days after the last dose or the start of new anticancer therapy, whichever occurred first (maximum time on treatment was 8.9 months for Arm A, 7.7 months for Arm B, and 8.0 months for Arm C).
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
5.3%
1/19 • Number of events 1 • All-cause mortality was assessed through the end of study, February 26th, 2024 (maximum time on study was 12 months). Adverse events were assessed from the first dose of study drug to 30 days after the last dose or the start of new anticancer therapy, whichever occurred first (maximum time on treatment was 8.9 months for Arm A, 7.7 months for Arm B, and 8.0 months for Arm C).
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
0.00%
0/34 • All-cause mortality was assessed through the end of study, February 26th, 2024 (maximum time on study was 12 months). Adverse events were assessed from the first dose of study drug to 30 days after the last dose or the start of new anticancer therapy, whichever occurred first (maximum time on treatment was 8.9 months for Arm A, 7.7 months for Arm B, and 8.0 months for Arm C).
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
2.6%
1/39 • Number of events 1 • All-cause mortality was assessed through the end of study, February 26th, 2024 (maximum time on study was 12 months). Adverse events were assessed from the first dose of study drug to 30 days after the last dose or the start of new anticancer therapy, whichever occurred first (maximum time on treatment was 8.9 months for Arm A, 7.7 months for Arm B, and 8.0 months for Arm C).
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
0.00%
0/19 • All-cause mortality was assessed through the end of study, February 26th, 2024 (maximum time on study was 12 months). Adverse events were assessed from the first dose of study drug to 30 days after the last dose or the start of new anticancer therapy, whichever occurred first (maximum time on treatment was 8.9 months for Arm A, 7.7 months for Arm B, and 8.0 months for Arm C).
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
0.00%
0/34 • All-cause mortality was assessed through the end of study, February 26th, 2024 (maximum time on study was 12 months). Adverse events were assessed from the first dose of study drug to 30 days after the last dose or the start of new anticancer therapy, whichever occurred first (maximum time on treatment was 8.9 months for Arm A, 7.7 months for Arm B, and 8.0 months for Arm C).
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/39 • All-cause mortality was assessed through the end of study, February 26th, 2024 (maximum time on study was 12 months). Adverse events were assessed from the first dose of study drug to 30 days after the last dose or the start of new anticancer therapy, whichever occurred first (maximum time on treatment was 8.9 months for Arm A, 7.7 months for Arm B, and 8.0 months for Arm C).
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
0.00%
0/19 • All-cause mortality was assessed through the end of study, February 26th, 2024 (maximum time on study was 12 months). Adverse events were assessed from the first dose of study drug to 30 days after the last dose or the start of new anticancer therapy, whichever occurred first (maximum time on treatment was 8.9 months for Arm A, 7.7 months for Arm B, and 8.0 months for Arm C).
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
2.9%
1/34 • Number of events 1 • All-cause mortality was assessed through the end of study, February 26th, 2024 (maximum time on study was 12 months). Adverse events were assessed from the first dose of study drug to 30 days after the last dose or the start of new anticancer therapy, whichever occurred first (maximum time on treatment was 8.9 months for Arm A, 7.7 months for Arm B, and 8.0 months for Arm C).
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
5.1%
2/39 • Number of events 2 • All-cause mortality was assessed through the end of study, February 26th, 2024 (maximum time on study was 12 months). Adverse events were assessed from the first dose of study drug to 30 days after the last dose or the start of new anticancer therapy, whichever occurred first (maximum time on treatment was 8.9 months for Arm A, 7.7 months for Arm B, and 8.0 months for Arm C).
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
0.00%
0/19 • All-cause mortality was assessed through the end of study, February 26th, 2024 (maximum time on study was 12 months). Adverse events were assessed from the first dose of study drug to 30 days after the last dose or the start of new anticancer therapy, whichever occurred first (maximum time on treatment was 8.9 months for Arm A, 7.7 months for Arm B, and 8.0 months for Arm C).
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
2.9%
1/34 • Number of events 1 • All-cause mortality was assessed through the end of study, February 26th, 2024 (maximum time on study was 12 months). Adverse events were assessed from the first dose of study drug to 30 days after the last dose or the start of new anticancer therapy, whichever occurred first (maximum time on treatment was 8.9 months for Arm A, 7.7 months for Arm B, and 8.0 months for Arm C).
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
|
Skin and subcutaneous tissue disorders
Palmar-plantar erythrodysaesthesia syndrome
|
2.6%
1/39 • Number of events 1 • All-cause mortality was assessed through the end of study, February 26th, 2024 (maximum time on study was 12 months). Adverse events were assessed from the first dose of study drug to 30 days after the last dose or the start of new anticancer therapy, whichever occurred first (maximum time on treatment was 8.9 months for Arm A, 7.7 months for Arm B, and 8.0 months for Arm C).
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
0.00%
0/19 • All-cause mortality was assessed through the end of study, February 26th, 2024 (maximum time on study was 12 months). Adverse events were assessed from the first dose of study drug to 30 days after the last dose or the start of new anticancer therapy, whichever occurred first (maximum time on treatment was 8.9 months for Arm A, 7.7 months for Arm B, and 8.0 months for Arm C).
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
0.00%
0/34 • All-cause mortality was assessed through the end of study, February 26th, 2024 (maximum time on study was 12 months). Adverse events were assessed from the first dose of study drug to 30 days after the last dose or the start of new anticancer therapy, whichever occurred first (maximum time on treatment was 8.9 months for Arm A, 7.7 months for Arm B, and 8.0 months for Arm C).
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
|
Vascular disorders
Circulatory collapse
|
2.6%
1/39 • Number of events 1 • All-cause mortality was assessed through the end of study, February 26th, 2024 (maximum time on study was 12 months). Adverse events were assessed from the first dose of study drug to 30 days after the last dose or the start of new anticancer therapy, whichever occurred first (maximum time on treatment was 8.9 months for Arm A, 7.7 months for Arm B, and 8.0 months for Arm C).
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
0.00%
0/19 • All-cause mortality was assessed through the end of study, February 26th, 2024 (maximum time on study was 12 months). Adverse events were assessed from the first dose of study drug to 30 days after the last dose or the start of new anticancer therapy, whichever occurred first (maximum time on treatment was 8.9 months for Arm A, 7.7 months for Arm B, and 8.0 months for Arm C).
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
0.00%
0/34 • All-cause mortality was assessed through the end of study, February 26th, 2024 (maximum time on study was 12 months). Adverse events were assessed from the first dose of study drug to 30 days after the last dose or the start of new anticancer therapy, whichever occurred first (maximum time on treatment was 8.9 months for Arm A, 7.7 months for Arm B, and 8.0 months for Arm C).
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
|
Vascular disorders
Hypertension
|
0.00%
0/39 • All-cause mortality was assessed through the end of study, February 26th, 2024 (maximum time on study was 12 months). Adverse events were assessed from the first dose of study drug to 30 days after the last dose or the start of new anticancer therapy, whichever occurred first (maximum time on treatment was 8.9 months for Arm A, 7.7 months for Arm B, and 8.0 months for Arm C).
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
5.3%
1/19 • Number of events 1 • All-cause mortality was assessed through the end of study, February 26th, 2024 (maximum time on study was 12 months). Adverse events were assessed from the first dose of study drug to 30 days after the last dose or the start of new anticancer therapy, whichever occurred first (maximum time on treatment was 8.9 months for Arm A, 7.7 months for Arm B, and 8.0 months for Arm C).
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
2.9%
1/34 • Number of events 1 • All-cause mortality was assessed through the end of study, February 26th, 2024 (maximum time on study was 12 months). Adverse events were assessed from the first dose of study drug to 30 days after the last dose or the start of new anticancer therapy, whichever occurred first (maximum time on treatment was 8.9 months for Arm A, 7.7 months for Arm B, and 8.0 months for Arm C).
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
|
Vascular disorders
Shock
|
2.6%
1/39 • Number of events 1 • All-cause mortality was assessed through the end of study, February 26th, 2024 (maximum time on study was 12 months). Adverse events were assessed from the first dose of study drug to 30 days after the last dose or the start of new anticancer therapy, whichever occurred first (maximum time on treatment was 8.9 months for Arm A, 7.7 months for Arm B, and 8.0 months for Arm C).
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
5.3%
1/19 • Number of events 1 • All-cause mortality was assessed through the end of study, February 26th, 2024 (maximum time on study was 12 months). Adverse events were assessed from the first dose of study drug to 30 days after the last dose or the start of new anticancer therapy, whichever occurred first (maximum time on treatment was 8.9 months for Arm A, 7.7 months for Arm B, and 8.0 months for Arm C).
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
0.00%
0/34 • All-cause mortality was assessed through the end of study, February 26th, 2024 (maximum time on study was 12 months). Adverse events were assessed from the first dose of study drug to 30 days after the last dose or the start of new anticancer therapy, whichever occurred first (maximum time on treatment was 8.9 months for Arm A, 7.7 months for Arm B, and 8.0 months for Arm C).
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
|
Vascular disorders
Shock haemorrhagic
|
2.6%
1/39 • Number of events 1 • All-cause mortality was assessed through the end of study, February 26th, 2024 (maximum time on study was 12 months). Adverse events were assessed from the first dose of study drug to 30 days after the last dose or the start of new anticancer therapy, whichever occurred first (maximum time on treatment was 8.9 months for Arm A, 7.7 months for Arm B, and 8.0 months for Arm C).
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
0.00%
0/19 • All-cause mortality was assessed through the end of study, February 26th, 2024 (maximum time on study was 12 months). Adverse events were assessed from the first dose of study drug to 30 days after the last dose or the start of new anticancer therapy, whichever occurred first (maximum time on treatment was 8.9 months for Arm A, 7.7 months for Arm B, and 8.0 months for Arm C).
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
0.00%
0/34 • All-cause mortality was assessed through the end of study, February 26th, 2024 (maximum time on study was 12 months). Adverse events were assessed from the first dose of study drug to 30 days after the last dose or the start of new anticancer therapy, whichever occurred first (maximum time on treatment was 8.9 months for Arm A, 7.7 months for Arm B, and 8.0 months for Arm C).
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
Other adverse events
| Measure |
Arm A: Tislelizumab + Sitravatinib
n=39 participants at risk
Sitravatinib was administered orally at a dose of 100 mg once daily, while tislelizumab was given intravenously at 200 mg once every three weeks.
|
Arm B: Sitravatinib
n=19 participants at risk
Sitravatinib was administered orally at a dose of 100 mg once daily.
|
Arm C: Investigator-chosen Chemotherapy (ICC)
n=34 participants at risk
Investigators selected either docetaxel, administered intravenously at 75 mg/m² on Day 1 of each 21-day cycle, or irinotecan, given intravenously at 125 mg/m² on Days 1 and 8 of each 21-day cycle.
|
|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
30.8%
12/39 • Number of events 18 • All-cause mortality was assessed through the end of study, February 26th, 2024 (maximum time on study was 12 months). Adverse events were assessed from the first dose of study drug to 30 days after the last dose or the start of new anticancer therapy, whichever occurred first (maximum time on treatment was 8.9 months for Arm A, 7.7 months for Arm B, and 8.0 months for Arm C).
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
26.3%
5/19 • Number of events 6 • All-cause mortality was assessed through the end of study, February 26th, 2024 (maximum time on study was 12 months). Adverse events were assessed from the first dose of study drug to 30 days after the last dose or the start of new anticancer therapy, whichever occurred first (maximum time on treatment was 8.9 months for Arm A, 7.7 months for Arm B, and 8.0 months for Arm C).
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
58.8%
20/34 • Number of events 23 • All-cause mortality was assessed through the end of study, February 26th, 2024 (maximum time on study was 12 months). Adverse events were assessed from the first dose of study drug to 30 days after the last dose or the start of new anticancer therapy, whichever occurred first (maximum time on treatment was 8.9 months for Arm A, 7.7 months for Arm B, and 8.0 months for Arm C).
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
|
Blood and lymphatic system disorders
Lymphopenia
|
0.00%
0/39 • All-cause mortality was assessed through the end of study, February 26th, 2024 (maximum time on study was 12 months). Adverse events were assessed from the first dose of study drug to 30 days after the last dose or the start of new anticancer therapy, whichever occurred first (maximum time on treatment was 8.9 months for Arm A, 7.7 months for Arm B, and 8.0 months for Arm C).
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
5.3%
1/19 • Number of events 1 • All-cause mortality was assessed through the end of study, February 26th, 2024 (maximum time on study was 12 months). Adverse events were assessed from the first dose of study drug to 30 days after the last dose or the start of new anticancer therapy, whichever occurred first (maximum time on treatment was 8.9 months for Arm A, 7.7 months for Arm B, and 8.0 months for Arm C).
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
0.00%
0/34 • All-cause mortality was assessed through the end of study, February 26th, 2024 (maximum time on study was 12 months). Adverse events were assessed from the first dose of study drug to 30 days after the last dose or the start of new anticancer therapy, whichever occurred first (maximum time on treatment was 8.9 months for Arm A, 7.7 months for Arm B, and 8.0 months for Arm C).
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
|
Cardiac disorders
Aortic valve calcification
|
0.00%
0/39 • All-cause mortality was assessed through the end of study, February 26th, 2024 (maximum time on study was 12 months). Adverse events were assessed from the first dose of study drug to 30 days after the last dose or the start of new anticancer therapy, whichever occurred first (maximum time on treatment was 8.9 months for Arm A, 7.7 months for Arm B, and 8.0 months for Arm C).
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
5.3%
1/19 • Number of events 1 • All-cause mortality was assessed through the end of study, February 26th, 2024 (maximum time on study was 12 months). Adverse events were assessed from the first dose of study drug to 30 days after the last dose or the start of new anticancer therapy, whichever occurred first (maximum time on treatment was 8.9 months for Arm A, 7.7 months for Arm B, and 8.0 months for Arm C).
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
0.00%
0/34 • All-cause mortality was assessed through the end of study, February 26th, 2024 (maximum time on study was 12 months). Adverse events were assessed from the first dose of study drug to 30 days after the last dose or the start of new anticancer therapy, whichever occurred first (maximum time on treatment was 8.9 months for Arm A, 7.7 months for Arm B, and 8.0 months for Arm C).
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
|
Cardiac disorders
Cardiac failure
|
2.6%
1/39 • Number of events 1 • All-cause mortality was assessed through the end of study, February 26th, 2024 (maximum time on study was 12 months). Adverse events were assessed from the first dose of study drug to 30 days after the last dose or the start of new anticancer therapy, whichever occurred first (maximum time on treatment was 8.9 months for Arm A, 7.7 months for Arm B, and 8.0 months for Arm C).
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
5.3%
1/19 • Number of events 1 • All-cause mortality was assessed through the end of study, February 26th, 2024 (maximum time on study was 12 months). Adverse events were assessed from the first dose of study drug to 30 days after the last dose or the start of new anticancer therapy, whichever occurred first (maximum time on treatment was 8.9 months for Arm A, 7.7 months for Arm B, and 8.0 months for Arm C).
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
0.00%
0/34 • All-cause mortality was assessed through the end of study, February 26th, 2024 (maximum time on study was 12 months). Adverse events were assessed from the first dose of study drug to 30 days after the last dose or the start of new anticancer therapy, whichever occurred first (maximum time on treatment was 8.9 months for Arm A, 7.7 months for Arm B, and 8.0 months for Arm C).
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
|
Cardiac disorders
Left ventricular dysfunction
|
0.00%
0/39 • All-cause mortality was assessed through the end of study, February 26th, 2024 (maximum time on study was 12 months). Adverse events were assessed from the first dose of study drug to 30 days after the last dose or the start of new anticancer therapy, whichever occurred first (maximum time on treatment was 8.9 months for Arm A, 7.7 months for Arm B, and 8.0 months for Arm C).
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
5.3%
1/19 • Number of events 1 • All-cause mortality was assessed through the end of study, February 26th, 2024 (maximum time on study was 12 months). Adverse events were assessed from the first dose of study drug to 30 days after the last dose or the start of new anticancer therapy, whichever occurred first (maximum time on treatment was 8.9 months for Arm A, 7.7 months for Arm B, and 8.0 months for Arm C).
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
0.00%
0/34 • All-cause mortality was assessed through the end of study, February 26th, 2024 (maximum time on study was 12 months). Adverse events were assessed from the first dose of study drug to 30 days after the last dose or the start of new anticancer therapy, whichever occurred first (maximum time on treatment was 8.9 months for Arm A, 7.7 months for Arm B, and 8.0 months for Arm C).
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
|
Cardiac disorders
Supraventricular tachycardia
|
5.1%
2/39 • Number of events 2 • All-cause mortality was assessed through the end of study, February 26th, 2024 (maximum time on study was 12 months). Adverse events were assessed from the first dose of study drug to 30 days after the last dose or the start of new anticancer therapy, whichever occurred first (maximum time on treatment was 8.9 months for Arm A, 7.7 months for Arm B, and 8.0 months for Arm C).
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
0.00%
0/19 • All-cause mortality was assessed through the end of study, February 26th, 2024 (maximum time on study was 12 months). Adverse events were assessed from the first dose of study drug to 30 days after the last dose or the start of new anticancer therapy, whichever occurred first (maximum time on treatment was 8.9 months for Arm A, 7.7 months for Arm B, and 8.0 months for Arm C).
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
0.00%
0/34 • All-cause mortality was assessed through the end of study, February 26th, 2024 (maximum time on study was 12 months). Adverse events were assessed from the first dose of study drug to 30 days after the last dose or the start of new anticancer therapy, whichever occurred first (maximum time on treatment was 8.9 months for Arm A, 7.7 months for Arm B, and 8.0 months for Arm C).
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
|
Cardiac disorders
Tricuspid valve incompetence
|
0.00%
0/39 • All-cause mortality was assessed through the end of study, February 26th, 2024 (maximum time on study was 12 months). Adverse events were assessed from the first dose of study drug to 30 days after the last dose or the start of new anticancer therapy, whichever occurred first (maximum time on treatment was 8.9 months for Arm A, 7.7 months for Arm B, and 8.0 months for Arm C).
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
5.3%
1/19 • Number of events 1 • All-cause mortality was assessed through the end of study, February 26th, 2024 (maximum time on study was 12 months). Adverse events were assessed from the first dose of study drug to 30 days after the last dose or the start of new anticancer therapy, whichever occurred first (maximum time on treatment was 8.9 months for Arm A, 7.7 months for Arm B, and 8.0 months for Arm C).
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
0.00%
0/34 • All-cause mortality was assessed through the end of study, February 26th, 2024 (maximum time on study was 12 months). Adverse events were assessed from the first dose of study drug to 30 days after the last dose or the start of new anticancer therapy, whichever occurred first (maximum time on treatment was 8.9 months for Arm A, 7.7 months for Arm B, and 8.0 months for Arm C).
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
|
Endocrine disorders
Central hypothyroidism
|
0.00%
0/39 • All-cause mortality was assessed through the end of study, February 26th, 2024 (maximum time on study was 12 months). Adverse events were assessed from the first dose of study drug to 30 days after the last dose or the start of new anticancer therapy, whichever occurred first (maximum time on treatment was 8.9 months for Arm A, 7.7 months for Arm B, and 8.0 months for Arm C).
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
5.3%
1/19 • Number of events 1 • All-cause mortality was assessed through the end of study, February 26th, 2024 (maximum time on study was 12 months). Adverse events were assessed from the first dose of study drug to 30 days after the last dose or the start of new anticancer therapy, whichever occurred first (maximum time on treatment was 8.9 months for Arm A, 7.7 months for Arm B, and 8.0 months for Arm C).
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
0.00%
0/34 • All-cause mortality was assessed through the end of study, February 26th, 2024 (maximum time on study was 12 months). Adverse events were assessed from the first dose of study drug to 30 days after the last dose or the start of new anticancer therapy, whichever occurred first (maximum time on treatment was 8.9 months for Arm A, 7.7 months for Arm B, and 8.0 months for Arm C).
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
|
Endocrine disorders
Hypothyroidism
|
23.1%
9/39 • Number of events 10 • All-cause mortality was assessed through the end of study, February 26th, 2024 (maximum time on study was 12 months). Adverse events were assessed from the first dose of study drug to 30 days after the last dose or the start of new anticancer therapy, whichever occurred first (maximum time on treatment was 8.9 months for Arm A, 7.7 months for Arm B, and 8.0 months for Arm C).
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
10.5%
2/19 • Number of events 2 • All-cause mortality was assessed through the end of study, February 26th, 2024 (maximum time on study was 12 months). Adverse events were assessed from the first dose of study drug to 30 days after the last dose or the start of new anticancer therapy, whichever occurred first (maximum time on treatment was 8.9 months for Arm A, 7.7 months for Arm B, and 8.0 months for Arm C).
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
0.00%
0/34 • All-cause mortality was assessed through the end of study, February 26th, 2024 (maximum time on study was 12 months). Adverse events were assessed from the first dose of study drug to 30 days after the last dose or the start of new anticancer therapy, whichever occurred first (maximum time on treatment was 8.9 months for Arm A, 7.7 months for Arm B, and 8.0 months for Arm C).
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
|
Gastrointestinal disorders
Abdominal discomfort
|
2.6%
1/39 • Number of events 1 • All-cause mortality was assessed through the end of study, February 26th, 2024 (maximum time on study was 12 months). Adverse events were assessed from the first dose of study drug to 30 days after the last dose or the start of new anticancer therapy, whichever occurred first (maximum time on treatment was 8.9 months for Arm A, 7.7 months for Arm B, and 8.0 months for Arm C).
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
5.3%
1/19 • Number of events 1 • All-cause mortality was assessed through the end of study, February 26th, 2024 (maximum time on study was 12 months). Adverse events were assessed from the first dose of study drug to 30 days after the last dose or the start of new anticancer therapy, whichever occurred first (maximum time on treatment was 8.9 months for Arm A, 7.7 months for Arm B, and 8.0 months for Arm C).
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
0.00%
0/34 • All-cause mortality was assessed through the end of study, February 26th, 2024 (maximum time on study was 12 months). Adverse events were assessed from the first dose of study drug to 30 days after the last dose or the start of new anticancer therapy, whichever occurred first (maximum time on treatment was 8.9 months for Arm A, 7.7 months for Arm B, and 8.0 months for Arm C).
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
|
Gastrointestinal disorders
Abdominal distension
|
5.1%
2/39 • Number of events 2 • All-cause mortality was assessed through the end of study, February 26th, 2024 (maximum time on study was 12 months). Adverse events were assessed from the first dose of study drug to 30 days after the last dose or the start of new anticancer therapy, whichever occurred first (maximum time on treatment was 8.9 months for Arm A, 7.7 months for Arm B, and 8.0 months for Arm C).
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
0.00%
0/19 • All-cause mortality was assessed through the end of study, February 26th, 2024 (maximum time on study was 12 months). Adverse events were assessed from the first dose of study drug to 30 days after the last dose or the start of new anticancer therapy, whichever occurred first (maximum time on treatment was 8.9 months for Arm A, 7.7 months for Arm B, and 8.0 months for Arm C).
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
0.00%
0/34 • All-cause mortality was assessed through the end of study, February 26th, 2024 (maximum time on study was 12 months). Adverse events were assessed from the first dose of study drug to 30 days after the last dose or the start of new anticancer therapy, whichever occurred first (maximum time on treatment was 8.9 months for Arm A, 7.7 months for Arm B, and 8.0 months for Arm C).
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
|
Gastrointestinal disorders
Abdominal pain
|
5.1%
2/39 • Number of events 2 • All-cause mortality was assessed through the end of study, February 26th, 2024 (maximum time on study was 12 months). Adverse events were assessed from the first dose of study drug to 30 days after the last dose or the start of new anticancer therapy, whichever occurred first (maximum time on treatment was 8.9 months for Arm A, 7.7 months for Arm B, and 8.0 months for Arm C).
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
0.00%
0/19 • All-cause mortality was assessed through the end of study, February 26th, 2024 (maximum time on study was 12 months). Adverse events were assessed from the first dose of study drug to 30 days after the last dose or the start of new anticancer therapy, whichever occurred first (maximum time on treatment was 8.9 months for Arm A, 7.7 months for Arm B, and 8.0 months for Arm C).
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
0.00%
0/34 • All-cause mortality was assessed through the end of study, February 26th, 2024 (maximum time on study was 12 months). Adverse events were assessed from the first dose of study drug to 30 days after the last dose or the start of new anticancer therapy, whichever occurred first (maximum time on treatment was 8.9 months for Arm A, 7.7 months for Arm B, and 8.0 months for Arm C).
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
10.3%
4/39 • Number of events 6 • All-cause mortality was assessed through the end of study, February 26th, 2024 (maximum time on study was 12 months). Adverse events were assessed from the first dose of study drug to 30 days after the last dose or the start of new anticancer therapy, whichever occurred first (maximum time on treatment was 8.9 months for Arm A, 7.7 months for Arm B, and 8.0 months for Arm C).
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
15.8%
3/19 • Number of events 4 • All-cause mortality was assessed through the end of study, February 26th, 2024 (maximum time on study was 12 months). Adverse events were assessed from the first dose of study drug to 30 days after the last dose or the start of new anticancer therapy, whichever occurred first (maximum time on treatment was 8.9 months for Arm A, 7.7 months for Arm B, and 8.0 months for Arm C).
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
5.9%
2/34 • Number of events 2 • All-cause mortality was assessed through the end of study, February 26th, 2024 (maximum time on study was 12 months). Adverse events were assessed from the first dose of study drug to 30 days after the last dose or the start of new anticancer therapy, whichever occurred first (maximum time on treatment was 8.9 months for Arm A, 7.7 months for Arm B, and 8.0 months for Arm C).
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
|
Gastrointestinal disorders
Chronic gastritis
|
2.6%
1/39 • Number of events 1 • All-cause mortality was assessed through the end of study, February 26th, 2024 (maximum time on study was 12 months). Adverse events were assessed from the first dose of study drug to 30 days after the last dose or the start of new anticancer therapy, whichever occurred first (maximum time on treatment was 8.9 months for Arm A, 7.7 months for Arm B, and 8.0 months for Arm C).
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
5.3%
1/19 • Number of events 1 • All-cause mortality was assessed through the end of study, February 26th, 2024 (maximum time on study was 12 months). Adverse events were assessed from the first dose of study drug to 30 days after the last dose or the start of new anticancer therapy, whichever occurred first (maximum time on treatment was 8.9 months for Arm A, 7.7 months for Arm B, and 8.0 months for Arm C).
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
0.00%
0/34 • All-cause mortality was assessed through the end of study, February 26th, 2024 (maximum time on study was 12 months). Adverse events were assessed from the first dose of study drug to 30 days after the last dose or the start of new anticancer therapy, whichever occurred first (maximum time on treatment was 8.9 months for Arm A, 7.7 months for Arm B, and 8.0 months for Arm C).
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
|
Gastrointestinal disorders
Constipation
|
17.9%
7/39 • Number of events 11 • All-cause mortality was assessed through the end of study, February 26th, 2024 (maximum time on study was 12 months). Adverse events were assessed from the first dose of study drug to 30 days after the last dose or the start of new anticancer therapy, whichever occurred first (maximum time on treatment was 8.9 months for Arm A, 7.7 months for Arm B, and 8.0 months for Arm C).
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
5.3%
1/19 • Number of events 1 • All-cause mortality was assessed through the end of study, February 26th, 2024 (maximum time on study was 12 months). Adverse events were assessed from the first dose of study drug to 30 days after the last dose or the start of new anticancer therapy, whichever occurred first (maximum time on treatment was 8.9 months for Arm A, 7.7 months for Arm B, and 8.0 months for Arm C).
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
17.6%
6/34 • Number of events 6 • All-cause mortality was assessed through the end of study, February 26th, 2024 (maximum time on study was 12 months). Adverse events were assessed from the first dose of study drug to 30 days after the last dose or the start of new anticancer therapy, whichever occurred first (maximum time on treatment was 8.9 months for Arm A, 7.7 months for Arm B, and 8.0 months for Arm C).
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
|
Gastrointestinal disorders
Diarrhoea
|
12.8%
5/39 • Number of events 6 • All-cause mortality was assessed through the end of study, February 26th, 2024 (maximum time on study was 12 months). Adverse events were assessed from the first dose of study drug to 30 days after the last dose or the start of new anticancer therapy, whichever occurred first (maximum time on treatment was 8.9 months for Arm A, 7.7 months for Arm B, and 8.0 months for Arm C).
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
15.8%
3/19 • Number of events 4 • All-cause mortality was assessed through the end of study, February 26th, 2024 (maximum time on study was 12 months). Adverse events were assessed from the first dose of study drug to 30 days after the last dose or the start of new anticancer therapy, whichever occurred first (maximum time on treatment was 8.9 months for Arm A, 7.7 months for Arm B, and 8.0 months for Arm C).
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
41.2%
14/34 • Number of events 28 • All-cause mortality was assessed through the end of study, February 26th, 2024 (maximum time on study was 12 months). Adverse events were assessed from the first dose of study drug to 30 days after the last dose or the start of new anticancer therapy, whichever occurred first (maximum time on treatment was 8.9 months for Arm A, 7.7 months for Arm B, and 8.0 months for Arm C).
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
|
Gastrointestinal disorders
Dysphagia
|
2.6%
1/39 • Number of events 1 • All-cause mortality was assessed through the end of study, February 26th, 2024 (maximum time on study was 12 months). Adverse events were assessed from the first dose of study drug to 30 days after the last dose or the start of new anticancer therapy, whichever occurred first (maximum time on treatment was 8.9 months for Arm A, 7.7 months for Arm B, and 8.0 months for Arm C).
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
15.8%
3/19 • Number of events 3 • All-cause mortality was assessed through the end of study, February 26th, 2024 (maximum time on study was 12 months). Adverse events were assessed from the first dose of study drug to 30 days after the last dose or the start of new anticancer therapy, whichever occurred first (maximum time on treatment was 8.9 months for Arm A, 7.7 months for Arm B, and 8.0 months for Arm C).
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
2.9%
1/34 • Number of events 1 • All-cause mortality was assessed through the end of study, February 26th, 2024 (maximum time on study was 12 months). Adverse events were assessed from the first dose of study drug to 30 days after the last dose or the start of new anticancer therapy, whichever occurred first (maximum time on treatment was 8.9 months for Arm A, 7.7 months for Arm B, and 8.0 months for Arm C).
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/39 • All-cause mortality was assessed through the end of study, February 26th, 2024 (maximum time on study was 12 months). Adverse events were assessed from the first dose of study drug to 30 days after the last dose or the start of new anticancer therapy, whichever occurred first (maximum time on treatment was 8.9 months for Arm A, 7.7 months for Arm B, and 8.0 months for Arm C).
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
5.3%
1/19 • Number of events 1 • All-cause mortality was assessed through the end of study, February 26th, 2024 (maximum time on study was 12 months). Adverse events were assessed from the first dose of study drug to 30 days after the last dose or the start of new anticancer therapy, whichever occurred first (maximum time on treatment was 8.9 months for Arm A, 7.7 months for Arm B, and 8.0 months for Arm C).
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
0.00%
0/34 • All-cause mortality was assessed through the end of study, February 26th, 2024 (maximum time on study was 12 months). Adverse events were assessed from the first dose of study drug to 30 days after the last dose or the start of new anticancer therapy, whichever occurred first (maximum time on treatment was 8.9 months for Arm A, 7.7 months for Arm B, and 8.0 months for Arm C).
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
2.6%
1/39 • Number of events 1 • All-cause mortality was assessed through the end of study, February 26th, 2024 (maximum time on study was 12 months). Adverse events were assessed from the first dose of study drug to 30 days after the last dose or the start of new anticancer therapy, whichever occurred first (maximum time on treatment was 8.9 months for Arm A, 7.7 months for Arm B, and 8.0 months for Arm C).
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
0.00%
0/19 • All-cause mortality was assessed through the end of study, February 26th, 2024 (maximum time on study was 12 months). Adverse events were assessed from the first dose of study drug to 30 days after the last dose or the start of new anticancer therapy, whichever occurred first (maximum time on treatment was 8.9 months for Arm A, 7.7 months for Arm B, and 8.0 months for Arm C).
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
8.8%
3/34 • Number of events 3 • All-cause mortality was assessed through the end of study, February 26th, 2024 (maximum time on study was 12 months). Adverse events were assessed from the first dose of study drug to 30 days after the last dose or the start of new anticancer therapy, whichever occurred first (maximum time on treatment was 8.9 months for Arm A, 7.7 months for Arm B, and 8.0 months for Arm C).
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
|
Gastrointestinal disorders
Nausea
|
7.7%
3/39 • Number of events 3 • All-cause mortality was assessed through the end of study, February 26th, 2024 (maximum time on study was 12 months). Adverse events were assessed from the first dose of study drug to 30 days after the last dose or the start of new anticancer therapy, whichever occurred first (maximum time on treatment was 8.9 months for Arm A, 7.7 months for Arm B, and 8.0 months for Arm C).
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
21.1%
4/19 • Number of events 5 • All-cause mortality was assessed through the end of study, February 26th, 2024 (maximum time on study was 12 months). Adverse events were assessed from the first dose of study drug to 30 days after the last dose or the start of new anticancer therapy, whichever occurred first (maximum time on treatment was 8.9 months for Arm A, 7.7 months for Arm B, and 8.0 months for Arm C).
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
35.3%
12/34 • Number of events 14 • All-cause mortality was assessed through the end of study, February 26th, 2024 (maximum time on study was 12 months). Adverse events were assessed from the first dose of study drug to 30 days after the last dose or the start of new anticancer therapy, whichever occurred first (maximum time on treatment was 8.9 months for Arm A, 7.7 months for Arm B, and 8.0 months for Arm C).
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
|
Gastrointestinal disorders
Oesophageal obstruction
|
0.00%
0/39 • All-cause mortality was assessed through the end of study, February 26th, 2024 (maximum time on study was 12 months). Adverse events were assessed from the first dose of study drug to 30 days after the last dose or the start of new anticancer therapy, whichever occurred first (maximum time on treatment was 8.9 months for Arm A, 7.7 months for Arm B, and 8.0 months for Arm C).
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
5.3%
1/19 • Number of events 1 • All-cause mortality was assessed through the end of study, February 26th, 2024 (maximum time on study was 12 months). Adverse events were assessed from the first dose of study drug to 30 days after the last dose or the start of new anticancer therapy, whichever occurred first (maximum time on treatment was 8.9 months for Arm A, 7.7 months for Arm B, and 8.0 months for Arm C).
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
0.00%
0/34 • All-cause mortality was assessed through the end of study, February 26th, 2024 (maximum time on study was 12 months). Adverse events were assessed from the first dose of study drug to 30 days after the last dose or the start of new anticancer therapy, whichever occurred first (maximum time on treatment was 8.9 months for Arm A, 7.7 months for Arm B, and 8.0 months for Arm C).
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
|
Gastrointestinal disorders
Stomatitis
|
7.7%
3/39 • Number of events 3 • All-cause mortality was assessed through the end of study, February 26th, 2024 (maximum time on study was 12 months). Adverse events were assessed from the first dose of study drug to 30 days after the last dose or the start of new anticancer therapy, whichever occurred first (maximum time on treatment was 8.9 months for Arm A, 7.7 months for Arm B, and 8.0 months for Arm C).
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
5.3%
1/19 • Number of events 1 • All-cause mortality was assessed through the end of study, February 26th, 2024 (maximum time on study was 12 months). Adverse events were assessed from the first dose of study drug to 30 days after the last dose or the start of new anticancer therapy, whichever occurred first (maximum time on treatment was 8.9 months for Arm A, 7.7 months for Arm B, and 8.0 months for Arm C).
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
0.00%
0/34 • All-cause mortality was assessed through the end of study, February 26th, 2024 (maximum time on study was 12 months). Adverse events were assessed from the first dose of study drug to 30 days after the last dose or the start of new anticancer therapy, whichever occurred first (maximum time on treatment was 8.9 months for Arm A, 7.7 months for Arm B, and 8.0 months for Arm C).
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
|
Gastrointestinal disorders
Vomiting
|
5.1%
2/39 • Number of events 2 • All-cause mortality was assessed through the end of study, February 26th, 2024 (maximum time on study was 12 months). Adverse events were assessed from the first dose of study drug to 30 days after the last dose or the start of new anticancer therapy, whichever occurred first (maximum time on treatment was 8.9 months for Arm A, 7.7 months for Arm B, and 8.0 months for Arm C).
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
0.00%
0/19 • All-cause mortality was assessed through the end of study, February 26th, 2024 (maximum time on study was 12 months). Adverse events were assessed from the first dose of study drug to 30 days after the last dose or the start of new anticancer therapy, whichever occurred first (maximum time on treatment was 8.9 months for Arm A, 7.7 months for Arm B, and 8.0 months for Arm C).
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
29.4%
10/34 • Number of events 12 • All-cause mortality was assessed through the end of study, February 26th, 2024 (maximum time on study was 12 months). Adverse events were assessed from the first dose of study drug to 30 days after the last dose or the start of new anticancer therapy, whichever occurred first (maximum time on treatment was 8.9 months for Arm A, 7.7 months for Arm B, and 8.0 months for Arm C).
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
|
General disorders
Asthenia
|
15.4%
6/39 • Number of events 6 • All-cause mortality was assessed through the end of study, February 26th, 2024 (maximum time on study was 12 months). Adverse events were assessed from the first dose of study drug to 30 days after the last dose or the start of new anticancer therapy, whichever occurred first (maximum time on treatment was 8.9 months for Arm A, 7.7 months for Arm B, and 8.0 months for Arm C).
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
21.1%
4/19 • Number of events 5 • All-cause mortality was assessed through the end of study, February 26th, 2024 (maximum time on study was 12 months). Adverse events were assessed from the first dose of study drug to 30 days after the last dose or the start of new anticancer therapy, whichever occurred first (maximum time on treatment was 8.9 months for Arm A, 7.7 months for Arm B, and 8.0 months for Arm C).
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
8.8%
3/34 • Number of events 3 • All-cause mortality was assessed through the end of study, February 26th, 2024 (maximum time on study was 12 months). Adverse events were assessed from the first dose of study drug to 30 days after the last dose or the start of new anticancer therapy, whichever occurred first (maximum time on treatment was 8.9 months for Arm A, 7.7 months for Arm B, and 8.0 months for Arm C).
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
|
General disorders
Chest discomfort
|
5.1%
2/39 • Number of events 2 • All-cause mortality was assessed through the end of study, February 26th, 2024 (maximum time on study was 12 months). Adverse events were assessed from the first dose of study drug to 30 days after the last dose or the start of new anticancer therapy, whichever occurred first (maximum time on treatment was 8.9 months for Arm A, 7.7 months for Arm B, and 8.0 months for Arm C).
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
0.00%
0/19 • All-cause mortality was assessed through the end of study, February 26th, 2024 (maximum time on study was 12 months). Adverse events were assessed from the first dose of study drug to 30 days after the last dose or the start of new anticancer therapy, whichever occurred first (maximum time on treatment was 8.9 months for Arm A, 7.7 months for Arm B, and 8.0 months for Arm C).
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
0.00%
0/34 • All-cause mortality was assessed through the end of study, February 26th, 2024 (maximum time on study was 12 months). Adverse events were assessed from the first dose of study drug to 30 days after the last dose or the start of new anticancer therapy, whichever occurred first (maximum time on treatment was 8.9 months for Arm A, 7.7 months for Arm B, and 8.0 months for Arm C).
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
|
General disorders
Chest pain
|
10.3%
4/39 • Number of events 4 • All-cause mortality was assessed through the end of study, February 26th, 2024 (maximum time on study was 12 months). Adverse events were assessed from the first dose of study drug to 30 days after the last dose or the start of new anticancer therapy, whichever occurred first (maximum time on treatment was 8.9 months for Arm A, 7.7 months for Arm B, and 8.0 months for Arm C).
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
5.3%
1/19 • Number of events 1 • All-cause mortality was assessed through the end of study, February 26th, 2024 (maximum time on study was 12 months). Adverse events were assessed from the first dose of study drug to 30 days after the last dose or the start of new anticancer therapy, whichever occurred first (maximum time on treatment was 8.9 months for Arm A, 7.7 months for Arm B, and 8.0 months for Arm C).
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
0.00%
0/34 • All-cause mortality was assessed through the end of study, February 26th, 2024 (maximum time on study was 12 months). Adverse events were assessed from the first dose of study drug to 30 days after the last dose or the start of new anticancer therapy, whichever occurred first (maximum time on treatment was 8.9 months for Arm A, 7.7 months for Arm B, and 8.0 months for Arm C).
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
|
General disorders
Fatigue
|
5.1%
2/39 • Number of events 2 • All-cause mortality was assessed through the end of study, February 26th, 2024 (maximum time on study was 12 months). Adverse events were assessed from the first dose of study drug to 30 days after the last dose or the start of new anticancer therapy, whichever occurred first (maximum time on treatment was 8.9 months for Arm A, 7.7 months for Arm B, and 8.0 months for Arm C).
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
10.5%
2/19 • Number of events 2 • All-cause mortality was assessed through the end of study, February 26th, 2024 (maximum time on study was 12 months). Adverse events were assessed from the first dose of study drug to 30 days after the last dose or the start of new anticancer therapy, whichever occurred first (maximum time on treatment was 8.9 months for Arm A, 7.7 months for Arm B, and 8.0 months for Arm C).
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
5.9%
2/34 • Number of events 3 • All-cause mortality was assessed through the end of study, February 26th, 2024 (maximum time on study was 12 months). Adverse events were assessed from the first dose of study drug to 30 days after the last dose or the start of new anticancer therapy, whichever occurred first (maximum time on treatment was 8.9 months for Arm A, 7.7 months for Arm B, and 8.0 months for Arm C).
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
|
General disorders
Malaise
|
7.7%
3/39 • Number of events 4 • All-cause mortality was assessed through the end of study, February 26th, 2024 (maximum time on study was 12 months). Adverse events were assessed from the first dose of study drug to 30 days after the last dose or the start of new anticancer therapy, whichever occurred first (maximum time on treatment was 8.9 months for Arm A, 7.7 months for Arm B, and 8.0 months for Arm C).
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
0.00%
0/19 • All-cause mortality was assessed through the end of study, February 26th, 2024 (maximum time on study was 12 months). Adverse events were assessed from the first dose of study drug to 30 days after the last dose or the start of new anticancer therapy, whichever occurred first (maximum time on treatment was 8.9 months for Arm A, 7.7 months for Arm B, and 8.0 months for Arm C).
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
8.8%
3/34 • Number of events 3 • All-cause mortality was assessed through the end of study, February 26th, 2024 (maximum time on study was 12 months). Adverse events were assessed from the first dose of study drug to 30 days after the last dose or the start of new anticancer therapy, whichever occurred first (maximum time on treatment was 8.9 months for Arm A, 7.7 months for Arm B, and 8.0 months for Arm C).
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
|
General disorders
Oedema peripheral
|
0.00%
0/39 • All-cause mortality was assessed through the end of study, February 26th, 2024 (maximum time on study was 12 months). Adverse events were assessed from the first dose of study drug to 30 days after the last dose or the start of new anticancer therapy, whichever occurred first (maximum time on treatment was 8.9 months for Arm A, 7.7 months for Arm B, and 8.0 months for Arm C).
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
0.00%
0/19 • All-cause mortality was assessed through the end of study, February 26th, 2024 (maximum time on study was 12 months). Adverse events were assessed from the first dose of study drug to 30 days after the last dose or the start of new anticancer therapy, whichever occurred first (maximum time on treatment was 8.9 months for Arm A, 7.7 months for Arm B, and 8.0 months for Arm C).
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
5.9%
2/34 • Number of events 2 • All-cause mortality was assessed through the end of study, February 26th, 2024 (maximum time on study was 12 months). Adverse events were assessed from the first dose of study drug to 30 days after the last dose or the start of new anticancer therapy, whichever occurred first (maximum time on treatment was 8.9 months for Arm A, 7.7 months for Arm B, and 8.0 months for Arm C).
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
|
General disorders
Pain
|
0.00%
0/39 • All-cause mortality was assessed through the end of study, February 26th, 2024 (maximum time on study was 12 months). Adverse events were assessed from the first dose of study drug to 30 days after the last dose or the start of new anticancer therapy, whichever occurred first (maximum time on treatment was 8.9 months for Arm A, 7.7 months for Arm B, and 8.0 months for Arm C).
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
5.3%
1/19 • Number of events 1 • All-cause mortality was assessed through the end of study, February 26th, 2024 (maximum time on study was 12 months). Adverse events were assessed from the first dose of study drug to 30 days after the last dose or the start of new anticancer therapy, whichever occurred first (maximum time on treatment was 8.9 months for Arm A, 7.7 months for Arm B, and 8.0 months for Arm C).
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
0.00%
0/34 • All-cause mortality was assessed through the end of study, February 26th, 2024 (maximum time on study was 12 months). Adverse events were assessed from the first dose of study drug to 30 days after the last dose or the start of new anticancer therapy, whichever occurred first (maximum time on treatment was 8.9 months for Arm A, 7.7 months for Arm B, and 8.0 months for Arm C).
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
|
General disorders
Pyrexia
|
12.8%
5/39 • Number of events 7 • All-cause mortality was assessed through the end of study, February 26th, 2024 (maximum time on study was 12 months). Adverse events were assessed from the first dose of study drug to 30 days after the last dose or the start of new anticancer therapy, whichever occurred first (maximum time on treatment was 8.9 months for Arm A, 7.7 months for Arm B, and 8.0 months for Arm C).
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
0.00%
0/19 • All-cause mortality was assessed through the end of study, February 26th, 2024 (maximum time on study was 12 months). Adverse events were assessed from the first dose of study drug to 30 days after the last dose or the start of new anticancer therapy, whichever occurred first (maximum time on treatment was 8.9 months for Arm A, 7.7 months for Arm B, and 8.0 months for Arm C).
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
14.7%
5/34 • Number of events 7 • All-cause mortality was assessed through the end of study, February 26th, 2024 (maximum time on study was 12 months). Adverse events were assessed from the first dose of study drug to 30 days after the last dose or the start of new anticancer therapy, whichever occurred first (maximum time on treatment was 8.9 months for Arm A, 7.7 months for Arm B, and 8.0 months for Arm C).
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
|
Infections and infestations
COVID-19
|
10.3%
4/39 • Number of events 5 • All-cause mortality was assessed through the end of study, February 26th, 2024 (maximum time on study was 12 months). Adverse events were assessed from the first dose of study drug to 30 days after the last dose or the start of new anticancer therapy, whichever occurred first (maximum time on treatment was 8.9 months for Arm A, 7.7 months for Arm B, and 8.0 months for Arm C).
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
10.5%
2/19 • Number of events 7 • All-cause mortality was assessed through the end of study, February 26th, 2024 (maximum time on study was 12 months). Adverse events were assessed from the first dose of study drug to 30 days after the last dose or the start of new anticancer therapy, whichever occurred first (maximum time on treatment was 8.9 months for Arm A, 7.7 months for Arm B, and 8.0 months for Arm C).
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
11.8%
4/34 • Number of events 8 • All-cause mortality was assessed through the end of study, February 26th, 2024 (maximum time on study was 12 months). Adverse events were assessed from the first dose of study drug to 30 days after the last dose or the start of new anticancer therapy, whichever occurred first (maximum time on treatment was 8.9 months for Arm A, 7.7 months for Arm B, and 8.0 months for Arm C).
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
|
Infections and infestations
COVID-19 pneumonia
|
2.6%
1/39 • Number of events 1 • All-cause mortality was assessed through the end of study, February 26th, 2024 (maximum time on study was 12 months). Adverse events were assessed from the first dose of study drug to 30 days after the last dose or the start of new anticancer therapy, whichever occurred first (maximum time on treatment was 8.9 months for Arm A, 7.7 months for Arm B, and 8.0 months for Arm C).
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
5.3%
1/19 • Number of events 1 • All-cause mortality was assessed through the end of study, February 26th, 2024 (maximum time on study was 12 months). Adverse events were assessed from the first dose of study drug to 30 days after the last dose or the start of new anticancer therapy, whichever occurred first (maximum time on treatment was 8.9 months for Arm A, 7.7 months for Arm B, and 8.0 months for Arm C).
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
0.00%
0/34 • All-cause mortality was assessed through the end of study, February 26th, 2024 (maximum time on study was 12 months). Adverse events were assessed from the first dose of study drug to 30 days after the last dose or the start of new anticancer therapy, whichever occurred first (maximum time on treatment was 8.9 months for Arm A, 7.7 months for Arm B, and 8.0 months for Arm C).
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/39 • All-cause mortality was assessed through the end of study, February 26th, 2024 (maximum time on study was 12 months). Adverse events were assessed from the first dose of study drug to 30 days after the last dose or the start of new anticancer therapy, whichever occurred first (maximum time on treatment was 8.9 months for Arm A, 7.7 months for Arm B, and 8.0 months for Arm C).
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
5.3%
1/19 • Number of events 2 • All-cause mortality was assessed through the end of study, February 26th, 2024 (maximum time on study was 12 months). Adverse events were assessed from the first dose of study drug to 30 days after the last dose or the start of new anticancer therapy, whichever occurred first (maximum time on treatment was 8.9 months for Arm A, 7.7 months for Arm B, and 8.0 months for Arm C).
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
2.9%
1/34 • Number of events 1 • All-cause mortality was assessed through the end of study, February 26th, 2024 (maximum time on study was 12 months). Adverse events were assessed from the first dose of study drug to 30 days after the last dose or the start of new anticancer therapy, whichever occurred first (maximum time on treatment was 8.9 months for Arm A, 7.7 months for Arm B, and 8.0 months for Arm C).
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
|
Infections and infestations
Pneumonia
|
2.6%
1/39 • Number of events 1 • All-cause mortality was assessed through the end of study, February 26th, 2024 (maximum time on study was 12 months). Adverse events were assessed from the first dose of study drug to 30 days after the last dose or the start of new anticancer therapy, whichever occurred first (maximum time on treatment was 8.9 months for Arm A, 7.7 months for Arm B, and 8.0 months for Arm C).
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
0.00%
0/19 • All-cause mortality was assessed through the end of study, February 26th, 2024 (maximum time on study was 12 months). Adverse events were assessed from the first dose of study drug to 30 days after the last dose or the start of new anticancer therapy, whichever occurred first (maximum time on treatment was 8.9 months for Arm A, 7.7 months for Arm B, and 8.0 months for Arm C).
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
11.8%
4/34 • Number of events 4 • All-cause mortality was assessed through the end of study, February 26th, 2024 (maximum time on study was 12 months). Adverse events were assessed from the first dose of study drug to 30 days after the last dose or the start of new anticancer therapy, whichever occurred first (maximum time on treatment was 8.9 months for Arm A, 7.7 months for Arm B, and 8.0 months for Arm C).
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
|
Infections and infestations
Upper respiratory tract infection
|
2.6%
1/39 • Number of events 1 • All-cause mortality was assessed through the end of study, February 26th, 2024 (maximum time on study was 12 months). Adverse events were assessed from the first dose of study drug to 30 days after the last dose or the start of new anticancer therapy, whichever occurred first (maximum time on treatment was 8.9 months for Arm A, 7.7 months for Arm B, and 8.0 months for Arm C).
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
5.3%
1/19 • Number of events 1 • All-cause mortality was assessed through the end of study, February 26th, 2024 (maximum time on study was 12 months). Adverse events were assessed from the first dose of study drug to 30 days after the last dose or the start of new anticancer therapy, whichever occurred first (maximum time on treatment was 8.9 months for Arm A, 7.7 months for Arm B, and 8.0 months for Arm C).
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
0.00%
0/34 • All-cause mortality was assessed through the end of study, February 26th, 2024 (maximum time on study was 12 months). Adverse events were assessed from the first dose of study drug to 30 days after the last dose or the start of new anticancer therapy, whichever occurred first (maximum time on treatment was 8.9 months for Arm A, 7.7 months for Arm B, and 8.0 months for Arm C).
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
|
Infections and infestations
Urinary tract infection
|
5.1%
2/39 • Number of events 2 • All-cause mortality was assessed through the end of study, February 26th, 2024 (maximum time on study was 12 months). Adverse events were assessed from the first dose of study drug to 30 days after the last dose or the start of new anticancer therapy, whichever occurred first (maximum time on treatment was 8.9 months for Arm A, 7.7 months for Arm B, and 8.0 months for Arm C).
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
5.3%
1/19 • Number of events 1 • All-cause mortality was assessed through the end of study, February 26th, 2024 (maximum time on study was 12 months). Adverse events were assessed from the first dose of study drug to 30 days after the last dose or the start of new anticancer therapy, whichever occurred first (maximum time on treatment was 8.9 months for Arm A, 7.7 months for Arm B, and 8.0 months for Arm C).
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
0.00%
0/34 • All-cause mortality was assessed through the end of study, February 26th, 2024 (maximum time on study was 12 months). Adverse events were assessed from the first dose of study drug to 30 days after the last dose or the start of new anticancer therapy, whichever occurred first (maximum time on treatment was 8.9 months for Arm A, 7.7 months for Arm B, and 8.0 months for Arm C).
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
|
Investigations
Alanine aminotransferase increased
|
33.3%
13/39 • Number of events 22 • All-cause mortality was assessed through the end of study, February 26th, 2024 (maximum time on study was 12 months). Adverse events were assessed from the first dose of study drug to 30 days after the last dose or the start of new anticancer therapy, whichever occurred first (maximum time on treatment was 8.9 months for Arm A, 7.7 months for Arm B, and 8.0 months for Arm C).
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
31.6%
6/19 • Number of events 7 • All-cause mortality was assessed through the end of study, February 26th, 2024 (maximum time on study was 12 months). Adverse events were assessed from the first dose of study drug to 30 days after the last dose or the start of new anticancer therapy, whichever occurred first (maximum time on treatment was 8.9 months for Arm A, 7.7 months for Arm B, and 8.0 months for Arm C).
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
11.8%
4/34 • Number of events 9 • All-cause mortality was assessed through the end of study, February 26th, 2024 (maximum time on study was 12 months). Adverse events were assessed from the first dose of study drug to 30 days after the last dose or the start of new anticancer therapy, whichever occurred first (maximum time on treatment was 8.9 months for Arm A, 7.7 months for Arm B, and 8.0 months for Arm C).
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
|
Investigations
Alpha hydroxybutyrate dehydrogenase increased
|
7.7%
3/39 • Number of events 4 • All-cause mortality was assessed through the end of study, February 26th, 2024 (maximum time on study was 12 months). Adverse events were assessed from the first dose of study drug to 30 days after the last dose or the start of new anticancer therapy, whichever occurred first (maximum time on treatment was 8.9 months for Arm A, 7.7 months for Arm B, and 8.0 months for Arm C).
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
0.00%
0/19 • All-cause mortality was assessed through the end of study, February 26th, 2024 (maximum time on study was 12 months). Adverse events were assessed from the first dose of study drug to 30 days after the last dose or the start of new anticancer therapy, whichever occurred first (maximum time on treatment was 8.9 months for Arm A, 7.7 months for Arm B, and 8.0 months for Arm C).
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
0.00%
0/34 • All-cause mortality was assessed through the end of study, February 26th, 2024 (maximum time on study was 12 months). Adverse events were assessed from the first dose of study drug to 30 days after the last dose or the start of new anticancer therapy, whichever occurred first (maximum time on treatment was 8.9 months for Arm A, 7.7 months for Arm B, and 8.0 months for Arm C).
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
|
Investigations
Aspartate aminotransferase increased
|
38.5%
15/39 • Number of events 25 • All-cause mortality was assessed through the end of study, February 26th, 2024 (maximum time on study was 12 months). Adverse events were assessed from the first dose of study drug to 30 days after the last dose or the start of new anticancer therapy, whichever occurred first (maximum time on treatment was 8.9 months for Arm A, 7.7 months for Arm B, and 8.0 months for Arm C).
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
47.4%
9/19 • Number of events 11 • All-cause mortality was assessed through the end of study, February 26th, 2024 (maximum time on study was 12 months). Adverse events were assessed from the first dose of study drug to 30 days after the last dose or the start of new anticancer therapy, whichever occurred first (maximum time on treatment was 8.9 months for Arm A, 7.7 months for Arm B, and 8.0 months for Arm C).
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
5.9%
2/34 • Number of events 2 • All-cause mortality was assessed through the end of study, February 26th, 2024 (maximum time on study was 12 months). Adverse events were assessed from the first dose of study drug to 30 days after the last dose or the start of new anticancer therapy, whichever occurred first (maximum time on treatment was 8.9 months for Arm A, 7.7 months for Arm B, and 8.0 months for Arm C).
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
|
Investigations
Bilirubin conjugated increased
|
2.6%
1/39 • Number of events 1 • All-cause mortality was assessed through the end of study, February 26th, 2024 (maximum time on study was 12 months). Adverse events were assessed from the first dose of study drug to 30 days after the last dose or the start of new anticancer therapy, whichever occurred first (maximum time on treatment was 8.9 months for Arm A, 7.7 months for Arm B, and 8.0 months for Arm C).
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
5.3%
1/19 • Number of events 2 • All-cause mortality was assessed through the end of study, February 26th, 2024 (maximum time on study was 12 months). Adverse events were assessed from the first dose of study drug to 30 days after the last dose or the start of new anticancer therapy, whichever occurred first (maximum time on treatment was 8.9 months for Arm A, 7.7 months for Arm B, and 8.0 months for Arm C).
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
5.9%
2/34 • Number of events 2 • All-cause mortality was assessed through the end of study, February 26th, 2024 (maximum time on study was 12 months). Adverse events were assessed from the first dose of study drug to 30 days after the last dose or the start of new anticancer therapy, whichever occurred first (maximum time on treatment was 8.9 months for Arm A, 7.7 months for Arm B, and 8.0 months for Arm C).
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
|
Investigations
Blood alkaline phosphatase increased
|
5.1%
2/39 • Number of events 3 • All-cause mortality was assessed through the end of study, February 26th, 2024 (maximum time on study was 12 months). Adverse events were assessed from the first dose of study drug to 30 days after the last dose or the start of new anticancer therapy, whichever occurred first (maximum time on treatment was 8.9 months for Arm A, 7.7 months for Arm B, and 8.0 months for Arm C).
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
5.3%
1/19 • Number of events 2 • All-cause mortality was assessed through the end of study, February 26th, 2024 (maximum time on study was 12 months). Adverse events were assessed from the first dose of study drug to 30 days after the last dose or the start of new anticancer therapy, whichever occurred first (maximum time on treatment was 8.9 months for Arm A, 7.7 months for Arm B, and 8.0 months for Arm C).
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
11.8%
4/34 • Number of events 4 • All-cause mortality was assessed through the end of study, February 26th, 2024 (maximum time on study was 12 months). Adverse events were assessed from the first dose of study drug to 30 days after the last dose or the start of new anticancer therapy, whichever occurred first (maximum time on treatment was 8.9 months for Arm A, 7.7 months for Arm B, and 8.0 months for Arm C).
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
|
Investigations
Blood bilirubin increased
|
7.7%
3/39 • Number of events 4 • All-cause mortality was assessed through the end of study, February 26th, 2024 (maximum time on study was 12 months). Adverse events were assessed from the first dose of study drug to 30 days after the last dose or the start of new anticancer therapy, whichever occurred first (maximum time on treatment was 8.9 months for Arm A, 7.7 months for Arm B, and 8.0 months for Arm C).
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
5.3%
1/19 • Number of events 1 • All-cause mortality was assessed through the end of study, February 26th, 2024 (maximum time on study was 12 months). Adverse events were assessed from the first dose of study drug to 30 days after the last dose or the start of new anticancer therapy, whichever occurred first (maximum time on treatment was 8.9 months for Arm A, 7.7 months for Arm B, and 8.0 months for Arm C).
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
8.8%
3/34 • Number of events 3 • All-cause mortality was assessed through the end of study, February 26th, 2024 (maximum time on study was 12 months). Adverse events were assessed from the first dose of study drug to 30 days after the last dose or the start of new anticancer therapy, whichever occurred first (maximum time on treatment was 8.9 months for Arm A, 7.7 months for Arm B, and 8.0 months for Arm C).
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
|
Investigations
Blood creatine phosphokinase MB increased
|
15.4%
6/39 • Number of events 11 • All-cause mortality was assessed through the end of study, February 26th, 2024 (maximum time on study was 12 months). Adverse events were assessed from the first dose of study drug to 30 days after the last dose or the start of new anticancer therapy, whichever occurred first (maximum time on treatment was 8.9 months for Arm A, 7.7 months for Arm B, and 8.0 months for Arm C).
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
10.5%
2/19 • Number of events 2 • All-cause mortality was assessed through the end of study, February 26th, 2024 (maximum time on study was 12 months). Adverse events were assessed from the first dose of study drug to 30 days after the last dose or the start of new anticancer therapy, whichever occurred first (maximum time on treatment was 8.9 months for Arm A, 7.7 months for Arm B, and 8.0 months for Arm C).
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
2.9%
1/34 • Number of events 1 • All-cause mortality was assessed through the end of study, February 26th, 2024 (maximum time on study was 12 months). Adverse events were assessed from the first dose of study drug to 30 days after the last dose or the start of new anticancer therapy, whichever occurred first (maximum time on treatment was 8.9 months for Arm A, 7.7 months for Arm B, and 8.0 months for Arm C).
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
|
Investigations
Blood creatine phosphokinase increased
|
7.7%
3/39 • Number of events 5 • All-cause mortality was assessed through the end of study, February 26th, 2024 (maximum time on study was 12 months). Adverse events were assessed from the first dose of study drug to 30 days after the last dose or the start of new anticancer therapy, whichever occurred first (maximum time on treatment was 8.9 months for Arm A, 7.7 months for Arm B, and 8.0 months for Arm C).
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
5.3%
1/19 • Number of events 1 • All-cause mortality was assessed through the end of study, February 26th, 2024 (maximum time on study was 12 months). Adverse events were assessed from the first dose of study drug to 30 days after the last dose or the start of new anticancer therapy, whichever occurred first (maximum time on treatment was 8.9 months for Arm A, 7.7 months for Arm B, and 8.0 months for Arm C).
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
0.00%
0/34 • All-cause mortality was assessed through the end of study, February 26th, 2024 (maximum time on study was 12 months). Adverse events were assessed from the first dose of study drug to 30 days after the last dose or the start of new anticancer therapy, whichever occurred first (maximum time on treatment was 8.9 months for Arm A, 7.7 months for Arm B, and 8.0 months for Arm C).
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
|
Investigations
Blood creatinine increased
|
5.1%
2/39 • Number of events 3 • All-cause mortality was assessed through the end of study, February 26th, 2024 (maximum time on study was 12 months). Adverse events were assessed from the first dose of study drug to 30 days after the last dose or the start of new anticancer therapy, whichever occurred first (maximum time on treatment was 8.9 months for Arm A, 7.7 months for Arm B, and 8.0 months for Arm C).
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
0.00%
0/19 • All-cause mortality was assessed through the end of study, February 26th, 2024 (maximum time on study was 12 months). Adverse events were assessed from the first dose of study drug to 30 days after the last dose or the start of new anticancer therapy, whichever occurred first (maximum time on treatment was 8.9 months for Arm A, 7.7 months for Arm B, and 8.0 months for Arm C).
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
2.9%
1/34 • Number of events 1 • All-cause mortality was assessed through the end of study, February 26th, 2024 (maximum time on study was 12 months). Adverse events were assessed from the first dose of study drug to 30 days after the last dose or the start of new anticancer therapy, whichever occurred first (maximum time on treatment was 8.9 months for Arm A, 7.7 months for Arm B, and 8.0 months for Arm C).
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
|
Investigations
Blood lactate dehydrogenase increased
|
15.4%
6/39 • Number of events 8 • All-cause mortality was assessed through the end of study, February 26th, 2024 (maximum time on study was 12 months). Adverse events were assessed from the first dose of study drug to 30 days after the last dose or the start of new anticancer therapy, whichever occurred first (maximum time on treatment was 8.9 months for Arm A, 7.7 months for Arm B, and 8.0 months for Arm C).
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
10.5%
2/19 • Number of events 3 • All-cause mortality was assessed through the end of study, February 26th, 2024 (maximum time on study was 12 months). Adverse events were assessed from the first dose of study drug to 30 days after the last dose or the start of new anticancer therapy, whichever occurred first (maximum time on treatment was 8.9 months for Arm A, 7.7 months for Arm B, and 8.0 months for Arm C).
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
2.9%
1/34 • Number of events 1 • All-cause mortality was assessed through the end of study, February 26th, 2024 (maximum time on study was 12 months). Adverse events were assessed from the first dose of study drug to 30 days after the last dose or the start of new anticancer therapy, whichever occurred first (maximum time on treatment was 8.9 months for Arm A, 7.7 months for Arm B, and 8.0 months for Arm C).
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
|
Investigations
Blood potassium decreased
|
0.00%
0/39 • All-cause mortality was assessed through the end of study, February 26th, 2024 (maximum time on study was 12 months). Adverse events were assessed from the first dose of study drug to 30 days after the last dose or the start of new anticancer therapy, whichever occurred first (maximum time on treatment was 8.9 months for Arm A, 7.7 months for Arm B, and 8.0 months for Arm C).
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
5.3%
1/19 • Number of events 1 • All-cause mortality was assessed through the end of study, February 26th, 2024 (maximum time on study was 12 months). Adverse events were assessed from the first dose of study drug to 30 days after the last dose or the start of new anticancer therapy, whichever occurred first (maximum time on treatment was 8.9 months for Arm A, 7.7 months for Arm B, and 8.0 months for Arm C).
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
0.00%
0/34 • All-cause mortality was assessed through the end of study, February 26th, 2024 (maximum time on study was 12 months). Adverse events were assessed from the first dose of study drug to 30 days after the last dose or the start of new anticancer therapy, whichever occurred first (maximum time on treatment was 8.9 months for Arm A, 7.7 months for Arm B, and 8.0 months for Arm C).
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
|
Investigations
Blood pressure increased
|
10.3%
4/39 • Number of events 4 • All-cause mortality was assessed through the end of study, February 26th, 2024 (maximum time on study was 12 months). Adverse events were assessed from the first dose of study drug to 30 days after the last dose or the start of new anticancer therapy, whichever occurred first (maximum time on treatment was 8.9 months for Arm A, 7.7 months for Arm B, and 8.0 months for Arm C).
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
5.3%
1/19 • Number of events 1 • All-cause mortality was assessed through the end of study, February 26th, 2024 (maximum time on study was 12 months). Adverse events were assessed from the first dose of study drug to 30 days after the last dose or the start of new anticancer therapy, whichever occurred first (maximum time on treatment was 8.9 months for Arm A, 7.7 months for Arm B, and 8.0 months for Arm C).
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
0.00%
0/34 • All-cause mortality was assessed through the end of study, February 26th, 2024 (maximum time on study was 12 months). Adverse events were assessed from the first dose of study drug to 30 days after the last dose or the start of new anticancer therapy, whichever occurred first (maximum time on treatment was 8.9 months for Arm A, 7.7 months for Arm B, and 8.0 months for Arm C).
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
|
Investigations
Blood thyroid stimulating hormone increased
|
2.6%
1/39 • Number of events 1 • All-cause mortality was assessed through the end of study, February 26th, 2024 (maximum time on study was 12 months). Adverse events were assessed from the first dose of study drug to 30 days after the last dose or the start of new anticancer therapy, whichever occurred first (maximum time on treatment was 8.9 months for Arm A, 7.7 months for Arm B, and 8.0 months for Arm C).
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
5.3%
1/19 • Number of events 1 • All-cause mortality was assessed through the end of study, February 26th, 2024 (maximum time on study was 12 months). Adverse events were assessed from the first dose of study drug to 30 days after the last dose or the start of new anticancer therapy, whichever occurred first (maximum time on treatment was 8.9 months for Arm A, 7.7 months for Arm B, and 8.0 months for Arm C).
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
0.00%
0/34 • All-cause mortality was assessed through the end of study, February 26th, 2024 (maximum time on study was 12 months). Adverse events were assessed from the first dose of study drug to 30 days after the last dose or the start of new anticancer therapy, whichever occurred first (maximum time on treatment was 8.9 months for Arm A, 7.7 months for Arm B, and 8.0 months for Arm C).
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
|
Investigations
Blood urea increased
|
2.6%
1/39 • Number of events 3 • All-cause mortality was assessed through the end of study, February 26th, 2024 (maximum time on study was 12 months). Adverse events were assessed from the first dose of study drug to 30 days after the last dose or the start of new anticancer therapy, whichever occurred first (maximum time on treatment was 8.9 months for Arm A, 7.7 months for Arm B, and 8.0 months for Arm C).
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
0.00%
0/19 • All-cause mortality was assessed through the end of study, February 26th, 2024 (maximum time on study was 12 months). Adverse events were assessed from the first dose of study drug to 30 days after the last dose or the start of new anticancer therapy, whichever occurred first (maximum time on treatment was 8.9 months for Arm A, 7.7 months for Arm B, and 8.0 months for Arm C).
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
5.9%
2/34 • Number of events 2 • All-cause mortality was assessed through the end of study, February 26th, 2024 (maximum time on study was 12 months). Adverse events were assessed from the first dose of study drug to 30 days after the last dose or the start of new anticancer therapy, whichever occurred first (maximum time on treatment was 8.9 months for Arm A, 7.7 months for Arm B, and 8.0 months for Arm C).
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
|
Investigations
Electrocardiogram QT prolonged
|
0.00%
0/39 • All-cause mortality was assessed through the end of study, February 26th, 2024 (maximum time on study was 12 months). Adverse events were assessed from the first dose of study drug to 30 days after the last dose or the start of new anticancer therapy, whichever occurred first (maximum time on treatment was 8.9 months for Arm A, 7.7 months for Arm B, and 8.0 months for Arm C).
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
5.3%
1/19 • Number of events 2 • All-cause mortality was assessed through the end of study, February 26th, 2024 (maximum time on study was 12 months). Adverse events were assessed from the first dose of study drug to 30 days after the last dose or the start of new anticancer therapy, whichever occurred first (maximum time on treatment was 8.9 months for Arm A, 7.7 months for Arm B, and 8.0 months for Arm C).
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
0.00%
0/34 • All-cause mortality was assessed through the end of study, February 26th, 2024 (maximum time on study was 12 months). Adverse events were assessed from the first dose of study drug to 30 days after the last dose or the start of new anticancer therapy, whichever occurred first (maximum time on treatment was 8.9 months for Arm A, 7.7 months for Arm B, and 8.0 months for Arm C).
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
|
Investigations
Fibrin D dimer increased
|
2.6%
1/39 • Number of events 1 • All-cause mortality was assessed through the end of study, February 26th, 2024 (maximum time on study was 12 months). Adverse events were assessed from the first dose of study drug to 30 days after the last dose or the start of new anticancer therapy, whichever occurred first (maximum time on treatment was 8.9 months for Arm A, 7.7 months for Arm B, and 8.0 months for Arm C).
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
5.3%
1/19 • Number of events 1 • All-cause mortality was assessed through the end of study, February 26th, 2024 (maximum time on study was 12 months). Adverse events were assessed from the first dose of study drug to 30 days after the last dose or the start of new anticancer therapy, whichever occurred first (maximum time on treatment was 8.9 months for Arm A, 7.7 months for Arm B, and 8.0 months for Arm C).
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
2.9%
1/34 • Number of events 1 • All-cause mortality was assessed through the end of study, February 26th, 2024 (maximum time on study was 12 months). Adverse events were assessed from the first dose of study drug to 30 days after the last dose or the start of new anticancer therapy, whichever occurred first (maximum time on treatment was 8.9 months for Arm A, 7.7 months for Arm B, and 8.0 months for Arm C).
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
|
Investigations
Gamma-glutamyltransferase increased
|
2.6%
1/39 • Number of events 2 • All-cause mortality was assessed through the end of study, February 26th, 2024 (maximum time on study was 12 months). Adverse events were assessed from the first dose of study drug to 30 days after the last dose or the start of new anticancer therapy, whichever occurred first (maximum time on treatment was 8.9 months for Arm A, 7.7 months for Arm B, and 8.0 months for Arm C).
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
5.3%
1/19 • Number of events 1 • All-cause mortality was assessed through the end of study, February 26th, 2024 (maximum time on study was 12 months). Adverse events were assessed from the first dose of study drug to 30 days after the last dose or the start of new anticancer therapy, whichever occurred first (maximum time on treatment was 8.9 months for Arm A, 7.7 months for Arm B, and 8.0 months for Arm C).
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
5.9%
2/34 • Number of events 2 • All-cause mortality was assessed through the end of study, February 26th, 2024 (maximum time on study was 12 months). Adverse events were assessed from the first dose of study drug to 30 days after the last dose or the start of new anticancer therapy, whichever occurred first (maximum time on treatment was 8.9 months for Arm A, 7.7 months for Arm B, and 8.0 months for Arm C).
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
|
Investigations
High density lipoprotein decreased
|
0.00%
0/39 • All-cause mortality was assessed through the end of study, February 26th, 2024 (maximum time on study was 12 months). Adverse events were assessed from the first dose of study drug to 30 days after the last dose or the start of new anticancer therapy, whichever occurred first (maximum time on treatment was 8.9 months for Arm A, 7.7 months for Arm B, and 8.0 months for Arm C).
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
5.3%
1/19 • Number of events 2 • All-cause mortality was assessed through the end of study, February 26th, 2024 (maximum time on study was 12 months). Adverse events were assessed from the first dose of study drug to 30 days after the last dose or the start of new anticancer therapy, whichever occurred first (maximum time on treatment was 8.9 months for Arm A, 7.7 months for Arm B, and 8.0 months for Arm C).
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
0.00%
0/34 • All-cause mortality was assessed through the end of study, February 26th, 2024 (maximum time on study was 12 months). Adverse events were assessed from the first dose of study drug to 30 days after the last dose or the start of new anticancer therapy, whichever occurred first (maximum time on treatment was 8.9 months for Arm A, 7.7 months for Arm B, and 8.0 months for Arm C).
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
|
Investigations
Lipoprotein increased
|
0.00%
0/39 • All-cause mortality was assessed through the end of study, February 26th, 2024 (maximum time on study was 12 months). Adverse events were assessed from the first dose of study drug to 30 days after the last dose or the start of new anticancer therapy, whichever occurred first (maximum time on treatment was 8.9 months for Arm A, 7.7 months for Arm B, and 8.0 months for Arm C).
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
5.3%
1/19 • Number of events 1 • All-cause mortality was assessed through the end of study, February 26th, 2024 (maximum time on study was 12 months). Adverse events were assessed from the first dose of study drug to 30 days after the last dose or the start of new anticancer therapy, whichever occurred first (maximum time on treatment was 8.9 months for Arm A, 7.7 months for Arm B, and 8.0 months for Arm C).
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
0.00%
0/34 • All-cause mortality was assessed through the end of study, February 26th, 2024 (maximum time on study was 12 months). Adverse events were assessed from the first dose of study drug to 30 days after the last dose or the start of new anticancer therapy, whichever occurred first (maximum time on treatment was 8.9 months for Arm A, 7.7 months for Arm B, and 8.0 months for Arm C).
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
|
Investigations
Lymphocyte count decreased
|
7.7%
3/39 • Number of events 4 • All-cause mortality was assessed through the end of study, February 26th, 2024 (maximum time on study was 12 months). Adverse events were assessed from the first dose of study drug to 30 days after the last dose or the start of new anticancer therapy, whichever occurred first (maximum time on treatment was 8.9 months for Arm A, 7.7 months for Arm B, and 8.0 months for Arm C).
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
0.00%
0/19 • All-cause mortality was assessed through the end of study, February 26th, 2024 (maximum time on study was 12 months). Adverse events were assessed from the first dose of study drug to 30 days after the last dose or the start of new anticancer therapy, whichever occurred first (maximum time on treatment was 8.9 months for Arm A, 7.7 months for Arm B, and 8.0 months for Arm C).
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
14.7%
5/34 • Number of events 6 • All-cause mortality was assessed through the end of study, February 26th, 2024 (maximum time on study was 12 months). Adverse events were assessed from the first dose of study drug to 30 days after the last dose or the start of new anticancer therapy, whichever occurred first (maximum time on treatment was 8.9 months for Arm A, 7.7 months for Arm B, and 8.0 months for Arm C).
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
|
Investigations
Neutrophil count decreased
|
7.7%
3/39 • Number of events 3 • All-cause mortality was assessed through the end of study, February 26th, 2024 (maximum time on study was 12 months). Adverse events were assessed from the first dose of study drug to 30 days after the last dose or the start of new anticancer therapy, whichever occurred first (maximum time on treatment was 8.9 months for Arm A, 7.7 months for Arm B, and 8.0 months for Arm C).
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
26.3%
5/19 • Number of events 15 • All-cause mortality was assessed through the end of study, February 26th, 2024 (maximum time on study was 12 months). Adverse events were assessed from the first dose of study drug to 30 days after the last dose or the start of new anticancer therapy, whichever occurred first (maximum time on treatment was 8.9 months for Arm A, 7.7 months for Arm B, and 8.0 months for Arm C).
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
61.8%
21/34 • Number of events 48 • All-cause mortality was assessed through the end of study, February 26th, 2024 (maximum time on study was 12 months). Adverse events were assessed from the first dose of study drug to 30 days after the last dose or the start of new anticancer therapy, whichever occurred first (maximum time on treatment was 8.9 months for Arm A, 7.7 months for Arm B, and 8.0 months for Arm C).
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
|
Investigations
Neutrophil count increased
|
0.00%
0/39 • All-cause mortality was assessed through the end of study, February 26th, 2024 (maximum time on study was 12 months). Adverse events were assessed from the first dose of study drug to 30 days after the last dose or the start of new anticancer therapy, whichever occurred first (maximum time on treatment was 8.9 months for Arm A, 7.7 months for Arm B, and 8.0 months for Arm C).
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
0.00%
0/19 • All-cause mortality was assessed through the end of study, February 26th, 2024 (maximum time on study was 12 months). Adverse events were assessed from the first dose of study drug to 30 days after the last dose or the start of new anticancer therapy, whichever occurred first (maximum time on treatment was 8.9 months for Arm A, 7.7 months for Arm B, and 8.0 months for Arm C).
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
5.9%
2/34 • Number of events 2 • All-cause mortality was assessed through the end of study, February 26th, 2024 (maximum time on study was 12 months). Adverse events were assessed from the first dose of study drug to 30 days after the last dose or the start of new anticancer therapy, whichever occurred first (maximum time on treatment was 8.9 months for Arm A, 7.7 months for Arm B, and 8.0 months for Arm C).
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
|
Investigations
Platelet count decreased
|
23.1%
9/39 • Number of events 16 • All-cause mortality was assessed through the end of study, February 26th, 2024 (maximum time on study was 12 months). Adverse events were assessed from the first dose of study drug to 30 days after the last dose or the start of new anticancer therapy, whichever occurred first (maximum time on treatment was 8.9 months for Arm A, 7.7 months for Arm B, and 8.0 months for Arm C).
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
36.8%
7/19 • Number of events 9 • All-cause mortality was assessed through the end of study, February 26th, 2024 (maximum time on study was 12 months). Adverse events were assessed from the first dose of study drug to 30 days after the last dose or the start of new anticancer therapy, whichever occurred first (maximum time on treatment was 8.9 months for Arm A, 7.7 months for Arm B, and 8.0 months for Arm C).
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
17.6%
6/34 • Number of events 10 • All-cause mortality was assessed through the end of study, February 26th, 2024 (maximum time on study was 12 months). Adverse events were assessed from the first dose of study drug to 30 days after the last dose or the start of new anticancer therapy, whichever occurred first (maximum time on treatment was 8.9 months for Arm A, 7.7 months for Arm B, and 8.0 months for Arm C).
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
|
Investigations
Red blood cells urine positive
|
0.00%
0/39 • All-cause mortality was assessed through the end of study, February 26th, 2024 (maximum time on study was 12 months). Adverse events were assessed from the first dose of study drug to 30 days after the last dose or the start of new anticancer therapy, whichever occurred first (maximum time on treatment was 8.9 months for Arm A, 7.7 months for Arm B, and 8.0 months for Arm C).
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
5.3%
1/19 • Number of events 2 • All-cause mortality was assessed through the end of study, February 26th, 2024 (maximum time on study was 12 months). Adverse events were assessed from the first dose of study drug to 30 days after the last dose or the start of new anticancer therapy, whichever occurred first (maximum time on treatment was 8.9 months for Arm A, 7.7 months for Arm B, and 8.0 months for Arm C).
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
0.00%
0/34 • All-cause mortality was assessed through the end of study, February 26th, 2024 (maximum time on study was 12 months). Adverse events were assessed from the first dose of study drug to 30 days after the last dose or the start of new anticancer therapy, whichever occurred first (maximum time on treatment was 8.9 months for Arm A, 7.7 months for Arm B, and 8.0 months for Arm C).
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
|
Investigations
SARS-CoV-2 test positive
|
7.7%
3/39 • Number of events 3 • All-cause mortality was assessed through the end of study, February 26th, 2024 (maximum time on study was 12 months). Adverse events were assessed from the first dose of study drug to 30 days after the last dose or the start of new anticancer therapy, whichever occurred first (maximum time on treatment was 8.9 months for Arm A, 7.7 months for Arm B, and 8.0 months for Arm C).
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
5.3%
1/19 • Number of events 2 • All-cause mortality was assessed through the end of study, February 26th, 2024 (maximum time on study was 12 months). Adverse events were assessed from the first dose of study drug to 30 days after the last dose or the start of new anticancer therapy, whichever occurred first (maximum time on treatment was 8.9 months for Arm A, 7.7 months for Arm B, and 8.0 months for Arm C).
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
5.9%
2/34 • Number of events 2 • All-cause mortality was assessed through the end of study, February 26th, 2024 (maximum time on study was 12 months). Adverse events were assessed from the first dose of study drug to 30 days after the last dose or the start of new anticancer therapy, whichever occurred first (maximum time on treatment was 8.9 months for Arm A, 7.7 months for Arm B, and 8.0 months for Arm C).
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
|
Investigations
Urinary occult blood positive
|
5.1%
2/39 • Number of events 2 • All-cause mortality was assessed through the end of study, February 26th, 2024 (maximum time on study was 12 months). Adverse events were assessed from the first dose of study drug to 30 days after the last dose or the start of new anticancer therapy, whichever occurred first (maximum time on treatment was 8.9 months for Arm A, 7.7 months for Arm B, and 8.0 months for Arm C).
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
5.3%
1/19 • Number of events 2 • All-cause mortality was assessed through the end of study, February 26th, 2024 (maximum time on study was 12 months). Adverse events were assessed from the first dose of study drug to 30 days after the last dose or the start of new anticancer therapy, whichever occurred first (maximum time on treatment was 8.9 months for Arm A, 7.7 months for Arm B, and 8.0 months for Arm C).
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
0.00%
0/34 • All-cause mortality was assessed through the end of study, February 26th, 2024 (maximum time on study was 12 months). Adverse events were assessed from the first dose of study drug to 30 days after the last dose or the start of new anticancer therapy, whichever occurred first (maximum time on treatment was 8.9 months for Arm A, 7.7 months for Arm B, and 8.0 months for Arm C).
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
|
Investigations
Urobilinogen urine increased
|
0.00%
0/39 • All-cause mortality was assessed through the end of study, February 26th, 2024 (maximum time on study was 12 months). Adverse events were assessed from the first dose of study drug to 30 days after the last dose or the start of new anticancer therapy, whichever occurred first (maximum time on treatment was 8.9 months for Arm A, 7.7 months for Arm B, and 8.0 months for Arm C).
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
10.5%
2/19 • Number of events 2 • All-cause mortality was assessed through the end of study, February 26th, 2024 (maximum time on study was 12 months). Adverse events were assessed from the first dose of study drug to 30 days after the last dose or the start of new anticancer therapy, whichever occurred first (maximum time on treatment was 8.9 months for Arm A, 7.7 months for Arm B, and 8.0 months for Arm C).
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
0.00%
0/34 • All-cause mortality was assessed through the end of study, February 26th, 2024 (maximum time on study was 12 months). Adverse events were assessed from the first dose of study drug to 30 days after the last dose or the start of new anticancer therapy, whichever occurred first (maximum time on treatment was 8.9 months for Arm A, 7.7 months for Arm B, and 8.0 months for Arm C).
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
|
Investigations
Weight decreased
|
25.6%
10/39 • Number of events 11 • All-cause mortality was assessed through the end of study, February 26th, 2024 (maximum time on study was 12 months). Adverse events were assessed from the first dose of study drug to 30 days after the last dose or the start of new anticancer therapy, whichever occurred first (maximum time on treatment was 8.9 months for Arm A, 7.7 months for Arm B, and 8.0 months for Arm C).
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
36.8%
7/19 • Number of events 8 • All-cause mortality was assessed through the end of study, February 26th, 2024 (maximum time on study was 12 months). Adverse events were assessed from the first dose of study drug to 30 days after the last dose or the start of new anticancer therapy, whichever occurred first (maximum time on treatment was 8.9 months for Arm A, 7.7 months for Arm B, and 8.0 months for Arm C).
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
26.5%
9/34 • Number of events 12 • All-cause mortality was assessed through the end of study, February 26th, 2024 (maximum time on study was 12 months). Adverse events were assessed from the first dose of study drug to 30 days after the last dose or the start of new anticancer therapy, whichever occurred first (maximum time on treatment was 8.9 months for Arm A, 7.7 months for Arm B, and 8.0 months for Arm C).
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
|
Investigations
White blood cell count decreased
|
17.9%
7/39 • Number of events 12 • All-cause mortality was assessed through the end of study, February 26th, 2024 (maximum time on study was 12 months). Adverse events were assessed from the first dose of study drug to 30 days after the last dose or the start of new anticancer therapy, whichever occurred first (maximum time on treatment was 8.9 months for Arm A, 7.7 months for Arm B, and 8.0 months for Arm C).
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
26.3%
5/19 • Number of events 15 • All-cause mortality was assessed through the end of study, February 26th, 2024 (maximum time on study was 12 months). Adverse events were assessed from the first dose of study drug to 30 days after the last dose or the start of new anticancer therapy, whichever occurred first (maximum time on treatment was 8.9 months for Arm A, 7.7 months for Arm B, and 8.0 months for Arm C).
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
70.6%
24/34 • Number of events 55 • All-cause mortality was assessed through the end of study, February 26th, 2024 (maximum time on study was 12 months). Adverse events were assessed from the first dose of study drug to 30 days after the last dose or the start of new anticancer therapy, whichever occurred first (maximum time on treatment was 8.9 months for Arm A, 7.7 months for Arm B, and 8.0 months for Arm C).
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
|
Investigations
White blood cell count increased
|
0.00%
0/39 • All-cause mortality was assessed through the end of study, February 26th, 2024 (maximum time on study was 12 months). Adverse events were assessed from the first dose of study drug to 30 days after the last dose or the start of new anticancer therapy, whichever occurred first (maximum time on treatment was 8.9 months for Arm A, 7.7 months for Arm B, and 8.0 months for Arm C).
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
0.00%
0/19 • All-cause mortality was assessed through the end of study, February 26th, 2024 (maximum time on study was 12 months). Adverse events were assessed from the first dose of study drug to 30 days after the last dose or the start of new anticancer therapy, whichever occurred first (maximum time on treatment was 8.9 months for Arm A, 7.7 months for Arm B, and 8.0 months for Arm C).
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
5.9%
2/34 • Number of events 2 • All-cause mortality was assessed through the end of study, February 26th, 2024 (maximum time on study was 12 months). Adverse events were assessed from the first dose of study drug to 30 days after the last dose or the start of new anticancer therapy, whichever occurred first (maximum time on treatment was 8.9 months for Arm A, 7.7 months for Arm B, and 8.0 months for Arm C).
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
17.9%
7/39 • Number of events 8 • All-cause mortality was assessed through the end of study, February 26th, 2024 (maximum time on study was 12 months). Adverse events were assessed from the first dose of study drug to 30 days after the last dose or the start of new anticancer therapy, whichever occurred first (maximum time on treatment was 8.9 months for Arm A, 7.7 months for Arm B, and 8.0 months for Arm C).
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
31.6%
6/19 • Number of events 8 • All-cause mortality was assessed through the end of study, February 26th, 2024 (maximum time on study was 12 months). Adverse events were assessed from the first dose of study drug to 30 days after the last dose or the start of new anticancer therapy, whichever occurred first (maximum time on treatment was 8.9 months for Arm A, 7.7 months for Arm B, and 8.0 months for Arm C).
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
29.4%
10/34 • Number of events 12 • All-cause mortality was assessed through the end of study, February 26th, 2024 (maximum time on study was 12 months). Adverse events were assessed from the first dose of study drug to 30 days after the last dose or the start of new anticancer therapy, whichever occurred first (maximum time on treatment was 8.9 months for Arm A, 7.7 months for Arm B, and 8.0 months for Arm C).
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
0.00%
0/39 • All-cause mortality was assessed through the end of study, February 26th, 2024 (maximum time on study was 12 months). Adverse events were assessed from the first dose of study drug to 30 days after the last dose or the start of new anticancer therapy, whichever occurred first (maximum time on treatment was 8.9 months for Arm A, 7.7 months for Arm B, and 8.0 months for Arm C).
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
0.00%
0/19 • All-cause mortality was assessed through the end of study, February 26th, 2024 (maximum time on study was 12 months). Adverse events were assessed from the first dose of study drug to 30 days after the last dose or the start of new anticancer therapy, whichever occurred first (maximum time on treatment was 8.9 months for Arm A, 7.7 months for Arm B, and 8.0 months for Arm C).
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
5.9%
2/34 • Number of events 2 • All-cause mortality was assessed through the end of study, February 26th, 2024 (maximum time on study was 12 months). Adverse events were assessed from the first dose of study drug to 30 days after the last dose or the start of new anticancer therapy, whichever occurred first (maximum time on treatment was 8.9 months for Arm A, 7.7 months for Arm B, and 8.0 months for Arm C).
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
|
Metabolism and nutrition disorders
Hypercholesterolaemia
|
2.6%
1/39 • Number of events 1 • All-cause mortality was assessed through the end of study, February 26th, 2024 (maximum time on study was 12 months). Adverse events were assessed from the first dose of study drug to 30 days after the last dose or the start of new anticancer therapy, whichever occurred first (maximum time on treatment was 8.9 months for Arm A, 7.7 months for Arm B, and 8.0 months for Arm C).
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
10.5%
2/19 • Number of events 2 • All-cause mortality was assessed through the end of study, February 26th, 2024 (maximum time on study was 12 months). Adverse events were assessed from the first dose of study drug to 30 days after the last dose or the start of new anticancer therapy, whichever occurred first (maximum time on treatment was 8.9 months for Arm A, 7.7 months for Arm B, and 8.0 months for Arm C).
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
0.00%
0/34 • All-cause mortality was assessed through the end of study, February 26th, 2024 (maximum time on study was 12 months). Adverse events were assessed from the first dose of study drug to 30 days after the last dose or the start of new anticancer therapy, whichever occurred first (maximum time on treatment was 8.9 months for Arm A, 7.7 months for Arm B, and 8.0 months for Arm C).
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
2.6%
1/39 • Number of events 1 • All-cause mortality was assessed through the end of study, February 26th, 2024 (maximum time on study was 12 months). Adverse events were assessed from the first dose of study drug to 30 days after the last dose or the start of new anticancer therapy, whichever occurred first (maximum time on treatment was 8.9 months for Arm A, 7.7 months for Arm B, and 8.0 months for Arm C).
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
10.5%
2/19 • Number of events 2 • All-cause mortality was assessed through the end of study, February 26th, 2024 (maximum time on study was 12 months). Adverse events were assessed from the first dose of study drug to 30 days after the last dose or the start of new anticancer therapy, whichever occurred first (maximum time on treatment was 8.9 months for Arm A, 7.7 months for Arm B, and 8.0 months for Arm C).
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
0.00%
0/34 • All-cause mortality was assessed through the end of study, February 26th, 2024 (maximum time on study was 12 months). Adverse events were assessed from the first dose of study drug to 30 days after the last dose or the start of new anticancer therapy, whichever occurred first (maximum time on treatment was 8.9 months for Arm A, 7.7 months for Arm B, and 8.0 months for Arm C).
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
|
Metabolism and nutrition disorders
Hyperuricaemia
|
7.7%
3/39 • Number of events 5 • All-cause mortality was assessed through the end of study, February 26th, 2024 (maximum time on study was 12 months). Adverse events were assessed from the first dose of study drug to 30 days after the last dose or the start of new anticancer therapy, whichever occurred first (maximum time on treatment was 8.9 months for Arm A, 7.7 months for Arm B, and 8.0 months for Arm C).
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
0.00%
0/19 • All-cause mortality was assessed through the end of study, February 26th, 2024 (maximum time on study was 12 months). Adverse events were assessed from the first dose of study drug to 30 days after the last dose or the start of new anticancer therapy, whichever occurred first (maximum time on treatment was 8.9 months for Arm A, 7.7 months for Arm B, and 8.0 months for Arm C).
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
2.9%
1/34 • Number of events 3 • All-cause mortality was assessed through the end of study, February 26th, 2024 (maximum time on study was 12 months). Adverse events were assessed from the first dose of study drug to 30 days after the last dose or the start of new anticancer therapy, whichever occurred first (maximum time on treatment was 8.9 months for Arm A, 7.7 months for Arm B, and 8.0 months for Arm C).
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
25.6%
10/39 • Number of events 13 • All-cause mortality was assessed through the end of study, February 26th, 2024 (maximum time on study was 12 months). Adverse events were assessed from the first dose of study drug to 30 days after the last dose or the start of new anticancer therapy, whichever occurred first (maximum time on treatment was 8.9 months for Arm A, 7.7 months for Arm B, and 8.0 months for Arm C).
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
31.6%
6/19 • Number of events 6 • All-cause mortality was assessed through the end of study, February 26th, 2024 (maximum time on study was 12 months). Adverse events were assessed from the first dose of study drug to 30 days after the last dose or the start of new anticancer therapy, whichever occurred first (maximum time on treatment was 8.9 months for Arm A, 7.7 months for Arm B, and 8.0 months for Arm C).
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
23.5%
8/34 • Number of events 15 • All-cause mortality was assessed through the end of study, February 26th, 2024 (maximum time on study was 12 months). Adverse events were assessed from the first dose of study drug to 30 days after the last dose or the start of new anticancer therapy, whichever occurred first (maximum time on treatment was 8.9 months for Arm A, 7.7 months for Arm B, and 8.0 months for Arm C).
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
10.3%
4/39 • Number of events 6 • All-cause mortality was assessed through the end of study, February 26th, 2024 (maximum time on study was 12 months). Adverse events were assessed from the first dose of study drug to 30 days after the last dose or the start of new anticancer therapy, whichever occurred first (maximum time on treatment was 8.9 months for Arm A, 7.7 months for Arm B, and 8.0 months for Arm C).
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
5.3%
1/19 • Number of events 2 • All-cause mortality was assessed through the end of study, February 26th, 2024 (maximum time on study was 12 months). Adverse events were assessed from the first dose of study drug to 30 days after the last dose or the start of new anticancer therapy, whichever occurred first (maximum time on treatment was 8.9 months for Arm A, 7.7 months for Arm B, and 8.0 months for Arm C).
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
14.7%
5/34 • Number of events 5 • All-cause mortality was assessed through the end of study, February 26th, 2024 (maximum time on study was 12 months). Adverse events were assessed from the first dose of study drug to 30 days after the last dose or the start of new anticancer therapy, whichever occurred first (maximum time on treatment was 8.9 months for Arm A, 7.7 months for Arm B, and 8.0 months for Arm C).
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
|
Metabolism and nutrition disorders
Hypochloraemia
|
7.7%
3/39 • Number of events 5 • All-cause mortality was assessed through the end of study, February 26th, 2024 (maximum time on study was 12 months). Adverse events were assessed from the first dose of study drug to 30 days after the last dose or the start of new anticancer therapy, whichever occurred first (maximum time on treatment was 8.9 months for Arm A, 7.7 months for Arm B, and 8.0 months for Arm C).
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
5.3%
1/19 • Number of events 1 • All-cause mortality was assessed through the end of study, February 26th, 2024 (maximum time on study was 12 months). Adverse events were assessed from the first dose of study drug to 30 days after the last dose or the start of new anticancer therapy, whichever occurred first (maximum time on treatment was 8.9 months for Arm A, 7.7 months for Arm B, and 8.0 months for Arm C).
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
2.9%
1/34 • Number of events 1 • All-cause mortality was assessed through the end of study, February 26th, 2024 (maximum time on study was 12 months). Adverse events were assessed from the first dose of study drug to 30 days after the last dose or the start of new anticancer therapy, whichever occurred first (maximum time on treatment was 8.9 months for Arm A, 7.7 months for Arm B, and 8.0 months for Arm C).
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.00%
0/39 • All-cause mortality was assessed through the end of study, February 26th, 2024 (maximum time on study was 12 months). Adverse events were assessed from the first dose of study drug to 30 days after the last dose or the start of new anticancer therapy, whichever occurred first (maximum time on treatment was 8.9 months for Arm A, 7.7 months for Arm B, and 8.0 months for Arm C).
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
5.3%
1/19 • Number of events 2 • All-cause mortality was assessed through the end of study, February 26th, 2024 (maximum time on study was 12 months). Adverse events were assessed from the first dose of study drug to 30 days after the last dose or the start of new anticancer therapy, whichever occurred first (maximum time on treatment was 8.9 months for Arm A, 7.7 months for Arm B, and 8.0 months for Arm C).
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
2.9%
1/34 • Number of events 1 • All-cause mortality was assessed through the end of study, February 26th, 2024 (maximum time on study was 12 months). Adverse events were assessed from the first dose of study drug to 30 days after the last dose or the start of new anticancer therapy, whichever occurred first (maximum time on treatment was 8.9 months for Arm A, 7.7 months for Arm B, and 8.0 months for Arm C).
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
17.9%
7/39 • Number of events 12 • All-cause mortality was assessed through the end of study, February 26th, 2024 (maximum time on study was 12 months). Adverse events were assessed from the first dose of study drug to 30 days after the last dose or the start of new anticancer therapy, whichever occurred first (maximum time on treatment was 8.9 months for Arm A, 7.7 months for Arm B, and 8.0 months for Arm C).
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
26.3%
5/19 • Number of events 6 • All-cause mortality was assessed through the end of study, February 26th, 2024 (maximum time on study was 12 months). Adverse events were assessed from the first dose of study drug to 30 days after the last dose or the start of new anticancer therapy, whichever occurred first (maximum time on treatment was 8.9 months for Arm A, 7.7 months for Arm B, and 8.0 months for Arm C).
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
26.5%
9/34 • Number of events 17 • All-cause mortality was assessed through the end of study, February 26th, 2024 (maximum time on study was 12 months). Adverse events were assessed from the first dose of study drug to 30 days after the last dose or the start of new anticancer therapy, whichever occurred first (maximum time on treatment was 8.9 months for Arm A, 7.7 months for Arm B, and 8.0 months for Arm C).
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
17.9%
7/39 • Number of events 10 • All-cause mortality was assessed through the end of study, February 26th, 2024 (maximum time on study was 12 months). Adverse events were assessed from the first dose of study drug to 30 days after the last dose or the start of new anticancer therapy, whichever occurred first (maximum time on treatment was 8.9 months for Arm A, 7.7 months for Arm B, and 8.0 months for Arm C).
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
15.8%
3/19 • Number of events 4 • All-cause mortality was assessed through the end of study, February 26th, 2024 (maximum time on study was 12 months). Adverse events were assessed from the first dose of study drug to 30 days after the last dose or the start of new anticancer therapy, whichever occurred first (maximum time on treatment was 8.9 months for Arm A, 7.7 months for Arm B, and 8.0 months for Arm C).
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
11.8%
4/34 • Number of events 4 • All-cause mortality was assessed through the end of study, February 26th, 2024 (maximum time on study was 12 months). Adverse events were assessed from the first dose of study drug to 30 days after the last dose or the start of new anticancer therapy, whichever occurred first (maximum time on treatment was 8.9 months for Arm A, 7.7 months for Arm B, and 8.0 months for Arm C).
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
5.1%
2/39 • Number of events 2 • All-cause mortality was assessed through the end of study, February 26th, 2024 (maximum time on study was 12 months). Adverse events were assessed from the first dose of study drug to 30 days after the last dose or the start of new anticancer therapy, whichever occurred first (maximum time on treatment was 8.9 months for Arm A, 7.7 months for Arm B, and 8.0 months for Arm C).
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
5.3%
1/19 • Number of events 1 • All-cause mortality was assessed through the end of study, February 26th, 2024 (maximum time on study was 12 months). Adverse events were assessed from the first dose of study drug to 30 days after the last dose or the start of new anticancer therapy, whichever occurred first (maximum time on treatment was 8.9 months for Arm A, 7.7 months for Arm B, and 8.0 months for Arm C).
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
0.00%
0/34 • All-cause mortality was assessed through the end of study, February 26th, 2024 (maximum time on study was 12 months). Adverse events were assessed from the first dose of study drug to 30 days after the last dose or the start of new anticancer therapy, whichever occurred first (maximum time on treatment was 8.9 months for Arm A, 7.7 months for Arm B, and 8.0 months for Arm C).
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
5.1%
2/39 • Number of events 2 • All-cause mortality was assessed through the end of study, February 26th, 2024 (maximum time on study was 12 months). Adverse events were assessed from the first dose of study drug to 30 days after the last dose or the start of new anticancer therapy, whichever occurred first (maximum time on treatment was 8.9 months for Arm A, 7.7 months for Arm B, and 8.0 months for Arm C).
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
5.3%
1/19 • Number of events 1 • All-cause mortality was assessed through the end of study, February 26th, 2024 (maximum time on study was 12 months). Adverse events were assessed from the first dose of study drug to 30 days after the last dose or the start of new anticancer therapy, whichever occurred first (maximum time on treatment was 8.9 months for Arm A, 7.7 months for Arm B, and 8.0 months for Arm C).
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
0.00%
0/34 • All-cause mortality was assessed through the end of study, February 26th, 2024 (maximum time on study was 12 months). Adverse events were assessed from the first dose of study drug to 30 days after the last dose or the start of new anticancer therapy, whichever occurred first (maximum time on treatment was 8.9 months for Arm A, 7.7 months for Arm B, and 8.0 months for Arm C).
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
5.1%
2/39 • Number of events 2 • All-cause mortality was assessed through the end of study, February 26th, 2024 (maximum time on study was 12 months). Adverse events were assessed from the first dose of study drug to 30 days after the last dose or the start of new anticancer therapy, whichever occurred first (maximum time on treatment was 8.9 months for Arm A, 7.7 months for Arm B, and 8.0 months for Arm C).
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
0.00%
0/19 • All-cause mortality was assessed through the end of study, February 26th, 2024 (maximum time on study was 12 months). Adverse events were assessed from the first dose of study drug to 30 days after the last dose or the start of new anticancer therapy, whichever occurred first (maximum time on treatment was 8.9 months for Arm A, 7.7 months for Arm B, and 8.0 months for Arm C).
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
0.00%
0/34 • All-cause mortality was assessed through the end of study, February 26th, 2024 (maximum time on study was 12 months). Adverse events were assessed from the first dose of study drug to 30 days after the last dose or the start of new anticancer therapy, whichever occurred first (maximum time on treatment was 8.9 months for Arm A, 7.7 months for Arm B, and 8.0 months for Arm C).
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
5.1%
2/39 • Number of events 2 • All-cause mortality was assessed through the end of study, February 26th, 2024 (maximum time on study was 12 months). Adverse events were assessed from the first dose of study drug to 30 days after the last dose or the start of new anticancer therapy, whichever occurred first (maximum time on treatment was 8.9 months for Arm A, 7.7 months for Arm B, and 8.0 months for Arm C).
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
5.3%
1/19 • Number of events 1 • All-cause mortality was assessed through the end of study, February 26th, 2024 (maximum time on study was 12 months). Adverse events were assessed from the first dose of study drug to 30 days after the last dose or the start of new anticancer therapy, whichever occurred first (maximum time on treatment was 8.9 months for Arm A, 7.7 months for Arm B, and 8.0 months for Arm C).
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
0.00%
0/34 • All-cause mortality was assessed through the end of study, February 26th, 2024 (maximum time on study was 12 months). Adverse events were assessed from the first dose of study drug to 30 days after the last dose or the start of new anticancer therapy, whichever occurred first (maximum time on treatment was 8.9 months for Arm A, 7.7 months for Arm B, and 8.0 months for Arm C).
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/39 • All-cause mortality was assessed through the end of study, February 26th, 2024 (maximum time on study was 12 months). Adverse events were assessed from the first dose of study drug to 30 days after the last dose or the start of new anticancer therapy, whichever occurred first (maximum time on treatment was 8.9 months for Arm A, 7.7 months for Arm B, and 8.0 months for Arm C).
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
10.5%
2/19 • Number of events 2 • All-cause mortality was assessed through the end of study, February 26th, 2024 (maximum time on study was 12 months). Adverse events were assessed from the first dose of study drug to 30 days after the last dose or the start of new anticancer therapy, whichever occurred first (maximum time on treatment was 8.9 months for Arm A, 7.7 months for Arm B, and 8.0 months for Arm C).
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
0.00%
0/34 • All-cause mortality was assessed through the end of study, February 26th, 2024 (maximum time on study was 12 months). Adverse events were assessed from the first dose of study drug to 30 days after the last dose or the start of new anticancer therapy, whichever occurred first (maximum time on treatment was 8.9 months for Arm A, 7.7 months for Arm B, and 8.0 months for Arm C).
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
|
Musculoskeletal and connective tissue disorders
Spinal osteoarthritis
|
0.00%
0/39 • All-cause mortality was assessed through the end of study, February 26th, 2024 (maximum time on study was 12 months). Adverse events were assessed from the first dose of study drug to 30 days after the last dose or the start of new anticancer therapy, whichever occurred first (maximum time on treatment was 8.9 months for Arm A, 7.7 months for Arm B, and 8.0 months for Arm C).
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
5.3%
1/19 • Number of events 1 • All-cause mortality was assessed through the end of study, February 26th, 2024 (maximum time on study was 12 months). Adverse events were assessed from the first dose of study drug to 30 days after the last dose or the start of new anticancer therapy, whichever occurred first (maximum time on treatment was 8.9 months for Arm A, 7.7 months for Arm B, and 8.0 months for Arm C).
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
0.00%
0/34 • All-cause mortality was assessed through the end of study, February 26th, 2024 (maximum time on study was 12 months). Adverse events were assessed from the first dose of study drug to 30 days after the last dose or the start of new anticancer therapy, whichever occurred first (maximum time on treatment was 8.9 months for Arm A, 7.7 months for Arm B, and 8.0 months for Arm C).
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cancer pain
|
2.6%
1/39 • Number of events 1 • All-cause mortality was assessed through the end of study, February 26th, 2024 (maximum time on study was 12 months). Adverse events were assessed from the first dose of study drug to 30 days after the last dose or the start of new anticancer therapy, whichever occurred first (maximum time on treatment was 8.9 months for Arm A, 7.7 months for Arm B, and 8.0 months for Arm C).
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
5.3%
1/19 • Number of events 1 • All-cause mortality was assessed through the end of study, February 26th, 2024 (maximum time on study was 12 months). Adverse events were assessed from the first dose of study drug to 30 days after the last dose or the start of new anticancer therapy, whichever occurred first (maximum time on treatment was 8.9 months for Arm A, 7.7 months for Arm B, and 8.0 months for Arm C).
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
0.00%
0/34 • All-cause mortality was assessed through the end of study, February 26th, 2024 (maximum time on study was 12 months). Adverse events were assessed from the first dose of study drug to 30 days after the last dose or the start of new anticancer therapy, whichever occurred first (maximum time on treatment was 8.9 months for Arm A, 7.7 months for Arm B, and 8.0 months for Arm C).
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
|
Nervous system disorders
Dizziness
|
5.1%
2/39 • Number of events 2 • All-cause mortality was assessed through the end of study, February 26th, 2024 (maximum time on study was 12 months). Adverse events were assessed from the first dose of study drug to 30 days after the last dose or the start of new anticancer therapy, whichever occurred first (maximum time on treatment was 8.9 months for Arm A, 7.7 months for Arm B, and 8.0 months for Arm C).
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
10.5%
2/19 • Number of events 2 • All-cause mortality was assessed through the end of study, February 26th, 2024 (maximum time on study was 12 months). Adverse events were assessed from the first dose of study drug to 30 days after the last dose or the start of new anticancer therapy, whichever occurred first (maximum time on treatment was 8.9 months for Arm A, 7.7 months for Arm B, and 8.0 months for Arm C).
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
0.00%
0/34 • All-cause mortality was assessed through the end of study, February 26th, 2024 (maximum time on study was 12 months). Adverse events were assessed from the first dose of study drug to 30 days after the last dose or the start of new anticancer therapy, whichever occurred first (maximum time on treatment was 8.9 months for Arm A, 7.7 months for Arm B, and 8.0 months for Arm C).
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
|
Nervous system disorders
Headache
|
10.3%
4/39 • Number of events 5 • All-cause mortality was assessed through the end of study, February 26th, 2024 (maximum time on study was 12 months). Adverse events were assessed from the first dose of study drug to 30 days after the last dose or the start of new anticancer therapy, whichever occurred first (maximum time on treatment was 8.9 months for Arm A, 7.7 months for Arm B, and 8.0 months for Arm C).
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
10.5%
2/19 • Number of events 2 • All-cause mortality was assessed through the end of study, February 26th, 2024 (maximum time on study was 12 months). Adverse events were assessed from the first dose of study drug to 30 days after the last dose or the start of new anticancer therapy, whichever occurred first (maximum time on treatment was 8.9 months for Arm A, 7.7 months for Arm B, and 8.0 months for Arm C).
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
0.00%
0/34 • All-cause mortality was assessed through the end of study, February 26th, 2024 (maximum time on study was 12 months). Adverse events were assessed from the first dose of study drug to 30 days after the last dose or the start of new anticancer therapy, whichever occurred first (maximum time on treatment was 8.9 months for Arm A, 7.7 months for Arm B, and 8.0 months for Arm C).
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
|
Nervous system disorders
Hypoaesthesia
|
2.6%
1/39 • Number of events 1 • All-cause mortality was assessed through the end of study, February 26th, 2024 (maximum time on study was 12 months). Adverse events were assessed from the first dose of study drug to 30 days after the last dose or the start of new anticancer therapy, whichever occurred first (maximum time on treatment was 8.9 months for Arm A, 7.7 months for Arm B, and 8.0 months for Arm C).
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
0.00%
0/19 • All-cause mortality was assessed through the end of study, February 26th, 2024 (maximum time on study was 12 months). Adverse events were assessed from the first dose of study drug to 30 days after the last dose or the start of new anticancer therapy, whichever occurred first (maximum time on treatment was 8.9 months for Arm A, 7.7 months for Arm B, and 8.0 months for Arm C).
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
5.9%
2/34 • Number of events 2 • All-cause mortality was assessed through the end of study, February 26th, 2024 (maximum time on study was 12 months). Adverse events were assessed from the first dose of study drug to 30 days after the last dose or the start of new anticancer therapy, whichever occurred first (maximum time on treatment was 8.9 months for Arm A, 7.7 months for Arm B, and 8.0 months for Arm C).
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
0.00%
0/39 • All-cause mortality was assessed through the end of study, February 26th, 2024 (maximum time on study was 12 months). Adverse events were assessed from the first dose of study drug to 30 days after the last dose or the start of new anticancer therapy, whichever occurred first (maximum time on treatment was 8.9 months for Arm A, 7.7 months for Arm B, and 8.0 months for Arm C).
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
5.3%
1/19 • Number of events 1 • All-cause mortality was assessed through the end of study, February 26th, 2024 (maximum time on study was 12 months). Adverse events were assessed from the first dose of study drug to 30 days after the last dose or the start of new anticancer therapy, whichever occurred first (maximum time on treatment was 8.9 months for Arm A, 7.7 months for Arm B, and 8.0 months for Arm C).
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
0.00%
0/34 • All-cause mortality was assessed through the end of study, February 26th, 2024 (maximum time on study was 12 months). Adverse events were assessed from the first dose of study drug to 30 days after the last dose or the start of new anticancer therapy, whichever occurred first (maximum time on treatment was 8.9 months for Arm A, 7.7 months for Arm B, and 8.0 months for Arm C).
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
|
Nervous system disorders
Taste disorder
|
0.00%
0/39 • All-cause mortality was assessed through the end of study, February 26th, 2024 (maximum time on study was 12 months). Adverse events were assessed from the first dose of study drug to 30 days after the last dose or the start of new anticancer therapy, whichever occurred first (maximum time on treatment was 8.9 months for Arm A, 7.7 months for Arm B, and 8.0 months for Arm C).
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
5.3%
1/19 • Number of events 1 • All-cause mortality was assessed through the end of study, February 26th, 2024 (maximum time on study was 12 months). Adverse events were assessed from the first dose of study drug to 30 days after the last dose or the start of new anticancer therapy, whichever occurred first (maximum time on treatment was 8.9 months for Arm A, 7.7 months for Arm B, and 8.0 months for Arm C).
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
0.00%
0/34 • All-cause mortality was assessed through the end of study, February 26th, 2024 (maximum time on study was 12 months). Adverse events were assessed from the first dose of study drug to 30 days after the last dose or the start of new anticancer therapy, whichever occurred first (maximum time on treatment was 8.9 months for Arm A, 7.7 months for Arm B, and 8.0 months for Arm C).
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
|
Psychiatric disorders
Insomnia
|
12.8%
5/39 • Number of events 5 • All-cause mortality was assessed through the end of study, February 26th, 2024 (maximum time on study was 12 months). Adverse events were assessed from the first dose of study drug to 30 days after the last dose or the start of new anticancer therapy, whichever occurred first (maximum time on treatment was 8.9 months for Arm A, 7.7 months for Arm B, and 8.0 months for Arm C).
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
0.00%
0/19 • All-cause mortality was assessed through the end of study, February 26th, 2024 (maximum time on study was 12 months). Adverse events were assessed from the first dose of study drug to 30 days after the last dose or the start of new anticancer therapy, whichever occurred first (maximum time on treatment was 8.9 months for Arm A, 7.7 months for Arm B, and 8.0 months for Arm C).
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
8.8%
3/34 • Number of events 4 • All-cause mortality was assessed through the end of study, February 26th, 2024 (maximum time on study was 12 months). Adverse events were assessed from the first dose of study drug to 30 days after the last dose or the start of new anticancer therapy, whichever occurred first (maximum time on treatment was 8.9 months for Arm A, 7.7 months for Arm B, and 8.0 months for Arm C).
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
|
Renal and urinary disorders
Albuminuria
|
0.00%
0/39 • All-cause mortality was assessed through the end of study, February 26th, 2024 (maximum time on study was 12 months). Adverse events were assessed from the first dose of study drug to 30 days after the last dose or the start of new anticancer therapy, whichever occurred first (maximum time on treatment was 8.9 months for Arm A, 7.7 months for Arm B, and 8.0 months for Arm C).
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
5.3%
1/19 • Number of events 1 • All-cause mortality was assessed through the end of study, February 26th, 2024 (maximum time on study was 12 months). Adverse events were assessed from the first dose of study drug to 30 days after the last dose or the start of new anticancer therapy, whichever occurred first (maximum time on treatment was 8.9 months for Arm A, 7.7 months for Arm B, and 8.0 months for Arm C).
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
0.00%
0/34 • All-cause mortality was assessed through the end of study, February 26th, 2024 (maximum time on study was 12 months). Adverse events were assessed from the first dose of study drug to 30 days after the last dose or the start of new anticancer therapy, whichever occurred first (maximum time on treatment was 8.9 months for Arm A, 7.7 months for Arm B, and 8.0 months for Arm C).
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
|
Renal and urinary disorders
Dysuria
|
5.1%
2/39 • Number of events 2 • All-cause mortality was assessed through the end of study, February 26th, 2024 (maximum time on study was 12 months). Adverse events were assessed from the first dose of study drug to 30 days after the last dose or the start of new anticancer therapy, whichever occurred first (maximum time on treatment was 8.9 months for Arm A, 7.7 months for Arm B, and 8.0 months for Arm C).
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
0.00%
0/19 • All-cause mortality was assessed through the end of study, February 26th, 2024 (maximum time on study was 12 months). Adverse events were assessed from the first dose of study drug to 30 days after the last dose or the start of new anticancer therapy, whichever occurred first (maximum time on treatment was 8.9 months for Arm A, 7.7 months for Arm B, and 8.0 months for Arm C).
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
0.00%
0/34 • All-cause mortality was assessed through the end of study, February 26th, 2024 (maximum time on study was 12 months). Adverse events were assessed from the first dose of study drug to 30 days after the last dose or the start of new anticancer therapy, whichever occurred first (maximum time on treatment was 8.9 months for Arm A, 7.7 months for Arm B, and 8.0 months for Arm C).
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
|
Renal and urinary disorders
Proteinuria
|
5.1%
2/39 • Number of events 2 • All-cause mortality was assessed through the end of study, February 26th, 2024 (maximum time on study was 12 months). Adverse events were assessed from the first dose of study drug to 30 days after the last dose or the start of new anticancer therapy, whichever occurred first (maximum time on treatment was 8.9 months for Arm A, 7.7 months for Arm B, and 8.0 months for Arm C).
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
10.5%
2/19 • Number of events 2 • All-cause mortality was assessed through the end of study, February 26th, 2024 (maximum time on study was 12 months). Adverse events were assessed from the first dose of study drug to 30 days after the last dose or the start of new anticancer therapy, whichever occurred first (maximum time on treatment was 8.9 months for Arm A, 7.7 months for Arm B, and 8.0 months for Arm C).
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
5.9%
2/34 • Number of events 2 • All-cause mortality was assessed through the end of study, February 26th, 2024 (maximum time on study was 12 months). Adverse events were assessed from the first dose of study drug to 30 days after the last dose or the start of new anticancer therapy, whichever occurred first (maximum time on treatment was 8.9 months for Arm A, 7.7 months for Arm B, and 8.0 months for Arm C).
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.00%
0/39 • All-cause mortality was assessed through the end of study, February 26th, 2024 (maximum time on study was 12 months). Adverse events were assessed from the first dose of study drug to 30 days after the last dose or the start of new anticancer therapy, whichever occurred first (maximum time on treatment was 8.9 months for Arm A, 7.7 months for Arm B, and 8.0 months for Arm C).
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
5.3%
1/19 • Number of events 1 • All-cause mortality was assessed through the end of study, February 26th, 2024 (maximum time on study was 12 months). Adverse events were assessed from the first dose of study drug to 30 days after the last dose or the start of new anticancer therapy, whichever occurred first (maximum time on treatment was 8.9 months for Arm A, 7.7 months for Arm B, and 8.0 months for Arm C).
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
0.00%
0/34 • All-cause mortality was assessed through the end of study, February 26th, 2024 (maximum time on study was 12 months). Adverse events were assessed from the first dose of study drug to 30 days after the last dose or the start of new anticancer therapy, whichever occurred first (maximum time on treatment was 8.9 months for Arm A, 7.7 months for Arm B, and 8.0 months for Arm C).
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
20.5%
8/39 • Number of events 10 • All-cause mortality was assessed through the end of study, February 26th, 2024 (maximum time on study was 12 months). Adverse events were assessed from the first dose of study drug to 30 days after the last dose or the start of new anticancer therapy, whichever occurred first (maximum time on treatment was 8.9 months for Arm A, 7.7 months for Arm B, and 8.0 months for Arm C).
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
15.8%
3/19 • Number of events 3 • All-cause mortality was assessed through the end of study, February 26th, 2024 (maximum time on study was 12 months). Adverse events were assessed from the first dose of study drug to 30 days after the last dose or the start of new anticancer therapy, whichever occurred first (maximum time on treatment was 8.9 months for Arm A, 7.7 months for Arm B, and 8.0 months for Arm C).
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
8.8%
3/34 • Number of events 3 • All-cause mortality was assessed through the end of study, February 26th, 2024 (maximum time on study was 12 months). Adverse events were assessed from the first dose of study drug to 30 days after the last dose or the start of new anticancer therapy, whichever occurred first (maximum time on treatment was 8.9 months for Arm A, 7.7 months for Arm B, and 8.0 months for Arm C).
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
15.4%
6/39 • Number of events 6 • All-cause mortality was assessed through the end of study, February 26th, 2024 (maximum time on study was 12 months). Adverse events were assessed from the first dose of study drug to 30 days after the last dose or the start of new anticancer therapy, whichever occurred first (maximum time on treatment was 8.9 months for Arm A, 7.7 months for Arm B, and 8.0 months for Arm C).
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
10.5%
2/19 • Number of events 2 • All-cause mortality was assessed through the end of study, February 26th, 2024 (maximum time on study was 12 months). Adverse events were assessed from the first dose of study drug to 30 days after the last dose or the start of new anticancer therapy, whichever occurred first (maximum time on treatment was 8.9 months for Arm A, 7.7 months for Arm B, and 8.0 months for Arm C).
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
0.00%
0/34 • All-cause mortality was assessed through the end of study, February 26th, 2024 (maximum time on study was 12 months). Adverse events were assessed from the first dose of study drug to 30 days after the last dose or the start of new anticancer therapy, whichever occurred first (maximum time on treatment was 8.9 months for Arm A, 7.7 months for Arm B, and 8.0 months for Arm C).
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
2.6%
1/39 • Number of events 1 • All-cause mortality was assessed through the end of study, February 26th, 2024 (maximum time on study was 12 months). Adverse events were assessed from the first dose of study drug to 30 days after the last dose or the start of new anticancer therapy, whichever occurred first (maximum time on treatment was 8.9 months for Arm A, 7.7 months for Arm B, and 8.0 months for Arm C).
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
15.8%
3/19 • Number of events 3 • All-cause mortality was assessed through the end of study, February 26th, 2024 (maximum time on study was 12 months). Adverse events were assessed from the first dose of study drug to 30 days after the last dose or the start of new anticancer therapy, whichever occurred first (maximum time on treatment was 8.9 months for Arm A, 7.7 months for Arm B, and 8.0 months for Arm C).
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
0.00%
0/34 • All-cause mortality was assessed through the end of study, February 26th, 2024 (maximum time on study was 12 months). Adverse events were assessed from the first dose of study drug to 30 days after the last dose or the start of new anticancer therapy, whichever occurred first (maximum time on treatment was 8.9 months for Arm A, 7.7 months for Arm B, and 8.0 months for Arm C).
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/39 • All-cause mortality was assessed through the end of study, February 26th, 2024 (maximum time on study was 12 months). Adverse events were assessed from the first dose of study drug to 30 days after the last dose or the start of new anticancer therapy, whichever occurred first (maximum time on treatment was 8.9 months for Arm A, 7.7 months for Arm B, and 8.0 months for Arm C).
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
5.3%
1/19 • Number of events 2 • All-cause mortality was assessed through the end of study, February 26th, 2024 (maximum time on study was 12 months). Adverse events were assessed from the first dose of study drug to 30 days after the last dose or the start of new anticancer therapy, whichever occurred first (maximum time on treatment was 8.9 months for Arm A, 7.7 months for Arm B, and 8.0 months for Arm C).
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
0.00%
0/34 • All-cause mortality was assessed through the end of study, February 26th, 2024 (maximum time on study was 12 months). Adverse events were assessed from the first dose of study drug to 30 days after the last dose or the start of new anticancer therapy, whichever occurred first (maximum time on treatment was 8.9 months for Arm A, 7.7 months for Arm B, and 8.0 months for Arm C).
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Laryngeal pain
|
0.00%
0/39 • All-cause mortality was assessed through the end of study, February 26th, 2024 (maximum time on study was 12 months). Adverse events were assessed from the first dose of study drug to 30 days after the last dose or the start of new anticancer therapy, whichever occurred first (maximum time on treatment was 8.9 months for Arm A, 7.7 months for Arm B, and 8.0 months for Arm C).
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
5.3%
1/19 • Number of events 1 • All-cause mortality was assessed through the end of study, February 26th, 2024 (maximum time on study was 12 months). Adverse events were assessed from the first dose of study drug to 30 days after the last dose or the start of new anticancer therapy, whichever occurred first (maximum time on treatment was 8.9 months for Arm A, 7.7 months for Arm B, and 8.0 months for Arm C).
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
0.00%
0/34 • All-cause mortality was assessed through the end of study, February 26th, 2024 (maximum time on study was 12 months). Adverse events were assessed from the first dose of study drug to 30 days after the last dose or the start of new anticancer therapy, whichever occurred first (maximum time on treatment was 8.9 months for Arm A, 7.7 months for Arm B, and 8.0 months for Arm C).
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
5.1%
2/39 • Number of events 3 • All-cause mortality was assessed through the end of study, February 26th, 2024 (maximum time on study was 12 months). Adverse events were assessed from the first dose of study drug to 30 days after the last dose or the start of new anticancer therapy, whichever occurred first (maximum time on treatment was 8.9 months for Arm A, 7.7 months for Arm B, and 8.0 months for Arm C).
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
0.00%
0/19 • All-cause mortality was assessed through the end of study, February 26th, 2024 (maximum time on study was 12 months). Adverse events were assessed from the first dose of study drug to 30 days after the last dose or the start of new anticancer therapy, whichever occurred first (maximum time on treatment was 8.9 months for Arm A, 7.7 months for Arm B, and 8.0 months for Arm C).
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
0.00%
0/34 • All-cause mortality was assessed through the end of study, February 26th, 2024 (maximum time on study was 12 months). Adverse events were assessed from the first dose of study drug to 30 days after the last dose or the start of new anticancer therapy, whichever occurred first (maximum time on treatment was 8.9 months for Arm A, 7.7 months for Arm B, and 8.0 months for Arm C).
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
5.1%
2/39 • Number of events 3 • All-cause mortality was assessed through the end of study, February 26th, 2024 (maximum time on study was 12 months). Adverse events were assessed from the first dose of study drug to 30 days after the last dose or the start of new anticancer therapy, whichever occurred first (maximum time on treatment was 8.9 months for Arm A, 7.7 months for Arm B, and 8.0 months for Arm C).
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
5.3%
1/19 • Number of events 1 • All-cause mortality was assessed through the end of study, February 26th, 2024 (maximum time on study was 12 months). Adverse events were assessed from the first dose of study drug to 30 days after the last dose or the start of new anticancer therapy, whichever occurred first (maximum time on treatment was 8.9 months for Arm A, 7.7 months for Arm B, and 8.0 months for Arm C).
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
8.8%
3/34 • Number of events 3 • All-cause mortality was assessed through the end of study, February 26th, 2024 (maximum time on study was 12 months). Adverse events were assessed from the first dose of study drug to 30 days after the last dose or the start of new anticancer therapy, whichever occurred first (maximum time on treatment was 8.9 months for Arm A, 7.7 months for Arm B, and 8.0 months for Arm C).
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
0.00%
0/39 • All-cause mortality was assessed through the end of study, February 26th, 2024 (maximum time on study was 12 months). Adverse events were assessed from the first dose of study drug to 30 days after the last dose or the start of new anticancer therapy, whichever occurred first (maximum time on treatment was 8.9 months for Arm A, 7.7 months for Arm B, and 8.0 months for Arm C).
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
0.00%
0/19 • All-cause mortality was assessed through the end of study, February 26th, 2024 (maximum time on study was 12 months). Adverse events were assessed from the first dose of study drug to 30 days after the last dose or the start of new anticancer therapy, whichever occurred first (maximum time on treatment was 8.9 months for Arm A, 7.7 months for Arm B, and 8.0 months for Arm C).
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
8.8%
3/34 • Number of events 3 • All-cause mortality was assessed through the end of study, February 26th, 2024 (maximum time on study was 12 months). Adverse events were assessed from the first dose of study drug to 30 days after the last dose or the start of new anticancer therapy, whichever occurred first (maximum time on treatment was 8.9 months for Arm A, 7.7 months for Arm B, and 8.0 months for Arm C).
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
|
Skin and subcutaneous tissue disorders
Palmar-plantar erythrodysaesthesia syndrome
|
23.1%
9/39 • Number of events 10 • All-cause mortality was assessed through the end of study, February 26th, 2024 (maximum time on study was 12 months). Adverse events were assessed from the first dose of study drug to 30 days after the last dose or the start of new anticancer therapy, whichever occurred first (maximum time on treatment was 8.9 months for Arm A, 7.7 months for Arm B, and 8.0 months for Arm C).
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
42.1%
8/19 • Number of events 10 • All-cause mortality was assessed through the end of study, February 26th, 2024 (maximum time on study was 12 months). Adverse events were assessed from the first dose of study drug to 30 days after the last dose or the start of new anticancer therapy, whichever occurred first (maximum time on treatment was 8.9 months for Arm A, 7.7 months for Arm B, and 8.0 months for Arm C).
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
0.00%
0/34 • All-cause mortality was assessed through the end of study, February 26th, 2024 (maximum time on study was 12 months). Adverse events were assessed from the first dose of study drug to 30 days after the last dose or the start of new anticancer therapy, whichever occurred first (maximum time on treatment was 8.9 months for Arm A, 7.7 months for Arm B, and 8.0 months for Arm C).
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
|
Skin and subcutaneous tissue disorders
Rash
|
12.8%
5/39 • Number of events 5 • All-cause mortality was assessed through the end of study, February 26th, 2024 (maximum time on study was 12 months). Adverse events were assessed from the first dose of study drug to 30 days after the last dose or the start of new anticancer therapy, whichever occurred first (maximum time on treatment was 8.9 months for Arm A, 7.7 months for Arm B, and 8.0 months for Arm C).
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
5.3%
1/19 • Number of events 1 • All-cause mortality was assessed through the end of study, February 26th, 2024 (maximum time on study was 12 months). Adverse events were assessed from the first dose of study drug to 30 days after the last dose or the start of new anticancer therapy, whichever occurred first (maximum time on treatment was 8.9 months for Arm A, 7.7 months for Arm B, and 8.0 months for Arm C).
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
5.9%
2/34 • Number of events 2 • All-cause mortality was assessed through the end of study, February 26th, 2024 (maximum time on study was 12 months). Adverse events were assessed from the first dose of study drug to 30 days after the last dose or the start of new anticancer therapy, whichever occurred first (maximum time on treatment was 8.9 months for Arm A, 7.7 months for Arm B, and 8.0 months for Arm C).
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
|
Vascular disorders
Hypertension
|
20.5%
8/39 • Number of events 10 • All-cause mortality was assessed through the end of study, February 26th, 2024 (maximum time on study was 12 months). Adverse events were assessed from the first dose of study drug to 30 days after the last dose or the start of new anticancer therapy, whichever occurred first (maximum time on treatment was 8.9 months for Arm A, 7.7 months for Arm B, and 8.0 months for Arm C).
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
21.1%
4/19 • Number of events 4 • All-cause mortality was assessed through the end of study, February 26th, 2024 (maximum time on study was 12 months). Adverse events were assessed from the first dose of study drug to 30 days after the last dose or the start of new anticancer therapy, whichever occurred first (maximum time on treatment was 8.9 months for Arm A, 7.7 months for Arm B, and 8.0 months for Arm C).
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
2.9%
1/34 • Number of events 1 • All-cause mortality was assessed through the end of study, February 26th, 2024 (maximum time on study was 12 months). Adverse events were assessed from the first dose of study drug to 30 days after the last dose or the start of new anticancer therapy, whichever occurred first (maximum time on treatment was 8.9 months for Arm A, 7.7 months for Arm B, and 8.0 months for Arm C).
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
|
Vascular disorders
Hypotension
|
0.00%
0/39 • All-cause mortality was assessed through the end of study, February 26th, 2024 (maximum time on study was 12 months). Adverse events were assessed from the first dose of study drug to 30 days after the last dose or the start of new anticancer therapy, whichever occurred first (maximum time on treatment was 8.9 months for Arm A, 7.7 months for Arm B, and 8.0 months for Arm C).
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
5.3%
1/19 • Number of events 5 • All-cause mortality was assessed through the end of study, February 26th, 2024 (maximum time on study was 12 months). Adverse events were assessed from the first dose of study drug to 30 days after the last dose or the start of new anticancer therapy, whichever occurred first (maximum time on treatment was 8.9 months for Arm A, 7.7 months for Arm B, and 8.0 months for Arm C).
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
2.9%
1/34 • Number of events 2 • All-cause mortality was assessed through the end of study, February 26th, 2024 (maximum time on study was 12 months). Adverse events were assessed from the first dose of study drug to 30 days after the last dose or the start of new anticancer therapy, whichever occurred first (maximum time on treatment was 8.9 months for Arm A, 7.7 months for Arm B, and 8.0 months for Arm C).
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
Additional Information
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