Trial Outcomes & Findings for Study of Ociperlimab Plus Tislelizumab Plus Chemoradiotherapy in Participants With Untreated Limited-Stage Small Cell Lung Cancer (NCT NCT04952597)
NCT ID: NCT04952597
Last Updated: 2024-10-26
Results Overview
Defined as the time from the date of randomization to the date of the first documented disease progression as determined by the investigator per RECIST v1.1 or death from any cause (whichever occurs first)
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
126 participants
Primary outcome timeframe
Up to approximately 2 years
Results posted on
2024-10-26
Participant Flow
Participants were enrolled in multiple study centers in China, South Korea, and the United States.
Participant milestones
| Measure |
Arm A: Ociperlimab + Tislelizumab
Ociperlimab plus tislelizumab combined with cCRT (at the investigator's discretion) for 4 cycles (each cycle is 28 days), followed by ociperlimab plus tislelizumab
Ociperlimab: Ociperlimab 900 milligrams (mg) administered intravenously once every 3 weeks on Day 1 of each cycle
Tislelizumab: Tislelizumab 200 mg administered intravenously once every 3 weeks on Day 1 of each cycle
Concurrent Chemoradiotherapy: Cisplatin/Carboplatin: Either cisplatin 75 milligrams/meters squared (mg/m2) administered intravenously once every 3 weeks on Day 1 of each cycle for 4 cycles or carboplatin at a dose of area under the curve (AUC) 5 administered intravenously once every 3 weeks on Day 1 of each cycle for 4 cycles.
Etoposide: (100 mg/m2) administered intravenously on Days 1, 2, and 3 of each cycle for 4 cycles
Thoracic radiation therapy (TRT): once daily fractions for 6 to 7 weeks for a total dose of 60 to 70 units of absorbed dose of ionizing radiation (Gy)
|
Arm B: Tislelizumab
Tislelizumab combined with cCRT (at the investigator's discretion) for 4 cycles, followed by tislelizumab alone
Tislelizumab: Tislelizumab 200 mg administered intravenously once every 3 weeks on Day 1 of each cycle
Concurrent Chemoradiotherapy: Cisplatin/Carboplatin: Either cisplatin 75 milligrams/meters squared (mg/m2) administered intravenously once every 3 weeks on Day 1 of each cycle for 4 cycles or carboplatin at a dose of area under the curve (AUC) 5 administered intravenously once every 3 weeks on Day 1 of each cycle for 4 cycles.
Etoposide: (100 mg/m2) administered intravenously on Days 1, 2, and 3 of each cycle for 4 cycles
Thoracic radiation therapy (TRT): once daily fractions for 6 to 7 weeks for a total dose of 60 to 70 units of absorbed dose of ionizing radiation (Gy)
|
Arm C: Concurrent Chemoradiotherapy (cCRT)
cCRT only for 4 cycles at the investigator's discretion
Concurrent Chemoradiotherapy: Cisplatin/Carboplatin: Either cisplatin 75 milligrams/meters squared (mg/m2) administered intravenously once every 3 weeks on Day 1 of each cycle for 4 cycles or carboplatin at a dose of area under the curve (AUC) 5 administered intravenously once every 3 weeks on Day 1 of each cycle for 4 cycles.
Etoposide: (100 mg/m2) administered intravenously on Days 1, 2, and 3 of each cycle for 4 cycles
Thoracic radiation therapy (TRT): once daily fractions for 6 to 7 weeks for a total dose of 60 to 70 units of absorbed dose of ionizing radiation (Gy)
|
|---|---|---|---|
|
Overall Study
STARTED
|
41
|
42
|
43
|
|
Overall Study
COMPLETED
|
28
|
28
|
25
|
|
Overall Study
NOT COMPLETED
|
13
|
14
|
18
|
Reasons for withdrawal
| Measure |
Arm A: Ociperlimab + Tislelizumab
Ociperlimab plus tislelizumab combined with cCRT (at the investigator's discretion) for 4 cycles (each cycle is 28 days), followed by ociperlimab plus tislelizumab
Ociperlimab: Ociperlimab 900 milligrams (mg) administered intravenously once every 3 weeks on Day 1 of each cycle
Tislelizumab: Tislelizumab 200 mg administered intravenously once every 3 weeks on Day 1 of each cycle
Concurrent Chemoradiotherapy: Cisplatin/Carboplatin: Either cisplatin 75 milligrams/meters squared (mg/m2) administered intravenously once every 3 weeks on Day 1 of each cycle for 4 cycles or carboplatin at a dose of area under the curve (AUC) 5 administered intravenously once every 3 weeks on Day 1 of each cycle for 4 cycles.
Etoposide: (100 mg/m2) administered intravenously on Days 1, 2, and 3 of each cycle for 4 cycles
Thoracic radiation therapy (TRT): once daily fractions for 6 to 7 weeks for a total dose of 60 to 70 units of absorbed dose of ionizing radiation (Gy)
|
Arm B: Tislelizumab
Tislelizumab combined with cCRT (at the investigator's discretion) for 4 cycles, followed by tislelizumab alone
Tislelizumab: Tislelizumab 200 mg administered intravenously once every 3 weeks on Day 1 of each cycle
Concurrent Chemoradiotherapy: Cisplatin/Carboplatin: Either cisplatin 75 milligrams/meters squared (mg/m2) administered intravenously once every 3 weeks on Day 1 of each cycle for 4 cycles or carboplatin at a dose of area under the curve (AUC) 5 administered intravenously once every 3 weeks on Day 1 of each cycle for 4 cycles.
Etoposide: (100 mg/m2) administered intravenously on Days 1, 2, and 3 of each cycle for 4 cycles
Thoracic radiation therapy (TRT): once daily fractions for 6 to 7 weeks for a total dose of 60 to 70 units of absorbed dose of ionizing radiation (Gy)
|
Arm C: Concurrent Chemoradiotherapy (cCRT)
cCRT only for 4 cycles at the investigator's discretion
Concurrent Chemoradiotherapy: Cisplatin/Carboplatin: Either cisplatin 75 milligrams/meters squared (mg/m2) administered intravenously once every 3 weeks on Day 1 of each cycle for 4 cycles or carboplatin at a dose of area under the curve (AUC) 5 administered intravenously once every 3 weeks on Day 1 of each cycle for 4 cycles.
Etoposide: (100 mg/m2) administered intravenously on Days 1, 2, and 3 of each cycle for 4 cycles
Thoracic radiation therapy (TRT): once daily fractions for 6 to 7 weeks for a total dose of 60 to 70 units of absorbed dose of ionizing radiation (Gy)
|
|---|---|---|---|
|
Overall Study
Death
|
12
|
13
|
14
|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
3
|
|
Overall Study
Lost to Follow-up
|
0
|
1
|
1
|
Baseline Characteristics
Study of Ociperlimab Plus Tislelizumab Plus Chemoradiotherapy in Participants With Untreated Limited-Stage Small Cell Lung Cancer
Baseline characteristics by cohort
| Measure |
Arm A: Ociperlimab + Tislelizumab
n=41 Participants
Ociperlimab plus tislelizumab combined with cCRT (at the investigator's discretion) for 4 cycles (each cycle is 28 days), followed by ociperlimab plus tislelizumab
Ociperlimab: Ociperlimab 900 milligrams (mg) administered intravenously once every 3 weeks on Day 1 of each cycle
Tislelizumab: Tislelizumab 200 mg administered intravenously once every 3 weeks on Day 1 of each cycle
Concurrent Chemoradiotherapy: Cisplatin/Carboplatin: Either cisplatin 75 milligrams/meters squared (mg/m2) administered intravenously once every 3 weeks on Day 1 of each cycle for 4 cycles or carboplatin at a dose of area under the curve (AUC) 5 administered intravenously once every 3 weeks on Day 1 of each cycle for 4 cycles.
Etoposide: (100 mg/m2) administered intravenously on Days 1, 2, and 3 of each cycle for 4 cycles
Thoracic radiation therapy (TRT): once daily fractions for 6 to 7 weeks for a total dose of 60 to 70 units of absorbed dose of ionizing radiation (Gy)
|
Arm B: Tislelizumab
n=42 Participants
Tislelizumab combined with cCRT (at the investigator's discretion) for 4 cycles, followed by tislelizumab alone
Tislelizumab: Tislelizumab 200 mg administered intravenously once every 3 weeks on Day 1 of each cycle
Concurrent Chemoradiotherapy: Cisplatin/Carboplatin: Either cisplatin 75 milligrams/meters squared (mg/m2) administered intravenously once every 3 weeks on Day 1 of each cycle for 4 cycles or carboplatin at a dose of area under the curve (AUC) 5 administered intravenously once every 3 weeks on Day 1 of each cycle for 4 cycles.
Etoposide: (100 mg/m2) administered intravenously on Days 1, 2, and 3 of each cycle for 4 cycles
Thoracic radiation therapy (TRT): once daily fractions for 6 to 7 weeks for a total dose of 60 to 70 units of absorbed dose of ionizing radiation (Gy)
|
Arm C: Concurrent Chemoradiotherapy (cCRT)
n=43 Participants
cCRT only for 4 cycles at the investigator's discretion
Concurrent Chemoradiotherapy: Cisplatin/Carboplatin: Either cisplatin 75 milligrams/meters squared (mg/m2) administered intravenously once every 3 weeks on Day 1 of each cycle for 4 cycles or carboplatin at a dose of area under the curve (AUC) 5 administered intravenously once every 3 weeks on Day 1 of each cycle for 4 cycles.
Etoposide: (100 mg/m2) administered intravenously on Days 1, 2, and 3 of each cycle for 4 cycles
Thoracic radiation therapy (TRT): once daily fractions for 6 to 7 weeks for a total dose of 60 to 70 units of absorbed dose of ionizing radiation (Gy)
|
Total
n=126 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
60.5 years
STANDARD_DEVIATION 9.50 • n=99 Participants
|
59.9 years
STANDARD_DEVIATION 7.11 • n=107 Participants
|
61.0 years
STANDARD_DEVIATION 9.54 • n=206 Participants
|
60.5 years
STANDARD_DEVIATION 8.73 • n=7 Participants
|
|
Sex: Female, Male
Female
|
10 Participants
n=99 Participants
|
9 Participants
n=107 Participants
|
8 Participants
n=206 Participants
|
27 Participants
n=7 Participants
|
|
Sex: Female, Male
Male
|
31 Participants
n=99 Participants
|
33 Participants
n=107 Participants
|
35 Participants
n=206 Participants
|
99 Participants
n=7 Participants
|
|
Race/Ethnicity, Customized
Asian
|
41 Participants
n=99 Participants
|
42 Participants
n=107 Participants
|
42 Participants
n=206 Participants
|
125 Participants
n=7 Participants
|
|
Race/Ethnicity, Customized
White
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
1 Participants
n=7 Participants
|
PRIMARY outcome
Timeframe: Up to approximately 2 yearsPopulation: The ITT analysis set includes all randomized participants
Defined as the time from the date of randomization to the date of the first documented disease progression as determined by the investigator per RECIST v1.1 or death from any cause (whichever occurs first)
Outcome measures
| Measure |
Arm A: Ociperlimab + Tislelizumab
n=41 Participants
Ociperlimab plus tislelizumab combined with cCRT (at the investigator's discretion) for 4 cycles (each cycle is 28 days), followed by ociperlimab plus tislelizumab
Ociperlimab: Ociperlimab 900 milligrams (mg) administered intravenously once every 3 weeks on Day 1 of each cycle
Tislelizumab: Tislelizumab 200 mg administered intravenously once every 3 weeks on Day 1 of each cycle
Concurrent Chemoradiotherapy: Cisplatin/Carboplatin: Either cisplatin 75 milligrams/meters squared (mg/m2) administered intravenously once every 3 weeks on Day 1 of each cycle for 4 cycles or carboplatin at a dose of area under the curve (AUC) 5 administered intravenously once every 3 weeks on Day 1 of each cycle for 4 cycles.
Etoposide: (100 mg/m2) administered intravenously on Days 1, 2, and 3 of each cycle for 4 cycles
Thoracic radiation therapy (TRT): once daily fractions for 6 to 7 weeks for a total dose of 60 to 70 units of absorbed dose of ionizing radiation (Gy)
|
Arm B: Tislelizumab
n=42 Participants
Tislelizumab combined with cCRT (at the investigator's discretion) for 4 cycles, followed by tislelizumab alone
Tislelizumab: Tislelizumab 200 mg administered intravenously once every 3 weeks on Day 1 of each cycle
Concurrent Chemoradiotherapy: Cisplatin/Carboplatin: Either cisplatin 75 milligrams/meters squared (mg/m2) administered intravenously once every 3 weeks on Day 1 of each cycle for 4 cycles or carboplatin at a dose of area under the curve (AUC) 5 administered intravenously once every 3 weeks on Day 1 of each cycle for 4 cycles.
Etoposide: (100 mg/m2) administered intravenously on Days 1, 2, and 3 of each cycle for 4 cycles
Thoracic radiation therapy (TRT): once daily fractions for 6 to 7 weeks for a total dose of 60 to 70 units of absorbed dose of ionizing radiation (Gy)
|
Arm C: Concurrent Chemoradiotherapy (cCRT)
n=43 Participants
cCRT only for 4 cycles at the investigator's discretion
Concurrent Chemoradiotherapy: Cisplatin/Carboplatin: Either cisplatin 75 milligrams/meters squared (mg/m2) administered intravenously once every 3 weeks on Day 1 of each cycle for 4 cycles or carboplatin at a dose of area under the curve (AUC) 5 administered intravenously once every 3 weeks on Day 1 of each cycle for 4 cycles.
Etoposide: (100 mg/m2) administered intravenously on Days 1, 2, and 3 of each cycle for 4 cycles
Thoracic radiation therapy (TRT): once daily fractions for 6 to 7 weeks for a total dose of 60 to 70 units of absorbed dose of ionizing radiation (Gy)
|
|---|---|---|---|
|
Progression Free Survival (PFS)
|
12.6 Months
Interval 8.7 to
NA: Not estimable due to insufficient number of participants with events
|
13.2 Months
Interval 8.5 to
NA: Not estimable due to insufficient number of participants with events
|
9.5 Months
Interval 8.3 to 14.4
|
SECONDARY outcome
Timeframe: Up to approximately 2 yearsPopulation: The Intent-To-Treat (ITT) analysis set includes all randomized participants
defined as the percentage of participants who had CR as assessed by the investigator per RECIST v1.1
Outcome measures
| Measure |
Arm A: Ociperlimab + Tislelizumab
n=41 Participants
Ociperlimab plus tislelizumab combined with cCRT (at the investigator's discretion) for 4 cycles (each cycle is 28 days), followed by ociperlimab plus tislelizumab
Ociperlimab: Ociperlimab 900 milligrams (mg) administered intravenously once every 3 weeks on Day 1 of each cycle
Tislelizumab: Tislelizumab 200 mg administered intravenously once every 3 weeks on Day 1 of each cycle
Concurrent Chemoradiotherapy: Cisplatin/Carboplatin: Either cisplatin 75 milligrams/meters squared (mg/m2) administered intravenously once every 3 weeks on Day 1 of each cycle for 4 cycles or carboplatin at a dose of area under the curve (AUC) 5 administered intravenously once every 3 weeks on Day 1 of each cycle for 4 cycles.
Etoposide: (100 mg/m2) administered intravenously on Days 1, 2, and 3 of each cycle for 4 cycles
Thoracic radiation therapy (TRT): once daily fractions for 6 to 7 weeks for a total dose of 60 to 70 units of absorbed dose of ionizing radiation (Gy)
|
Arm B: Tislelizumab
n=42 Participants
Tislelizumab combined with cCRT (at the investigator's discretion) for 4 cycles, followed by tislelizumab alone
Tislelizumab: Tislelizumab 200 mg administered intravenously once every 3 weeks on Day 1 of each cycle
Concurrent Chemoradiotherapy: Cisplatin/Carboplatin: Either cisplatin 75 milligrams/meters squared (mg/m2) administered intravenously once every 3 weeks on Day 1 of each cycle for 4 cycles or carboplatin at a dose of area under the curve (AUC) 5 administered intravenously once every 3 weeks on Day 1 of each cycle for 4 cycles.
Etoposide: (100 mg/m2) administered intravenously on Days 1, 2, and 3 of each cycle for 4 cycles
Thoracic radiation therapy (TRT): once daily fractions for 6 to 7 weeks for a total dose of 60 to 70 units of absorbed dose of ionizing radiation (Gy)
|
Arm C: Concurrent Chemoradiotherapy (cCRT)
n=43 Participants
cCRT only for 4 cycles at the investigator's discretion
Concurrent Chemoradiotherapy: Cisplatin/Carboplatin: Either cisplatin 75 milligrams/meters squared (mg/m2) administered intravenously once every 3 weeks on Day 1 of each cycle for 4 cycles or carboplatin at a dose of area under the curve (AUC) 5 administered intravenously once every 3 weeks on Day 1 of each cycle for 4 cycles.
Etoposide: (100 mg/m2) administered intravenously on Days 1, 2, and 3 of each cycle for 4 cycles
Thoracic radiation therapy (TRT): once daily fractions for 6 to 7 weeks for a total dose of 60 to 70 units of absorbed dose of ionizing radiation (Gy)
|
|---|---|---|---|
|
Complete Response Rate (CR)
|
7.3 percentage of participants
Interval 1.5 to 19.9
|
9.5 percentage of participants
Interval 2.7 to 22.6
|
2.3 percentage of participants
Interval 0.1 to 12.3
|
SECONDARY outcome
Timeframe: Up to approximately 2 yearsPopulation: The Intent-To-Treat (ITT) analysis set includes all randomized participants
defined as the percentage of participants who had CR or partial response (PR) as assessed by the investigator per RECIST v1.1
Outcome measures
| Measure |
Arm A: Ociperlimab + Tislelizumab
n=41 Participants
Ociperlimab plus tislelizumab combined with cCRT (at the investigator's discretion) for 4 cycles (each cycle is 28 days), followed by ociperlimab plus tislelizumab
Ociperlimab: Ociperlimab 900 milligrams (mg) administered intravenously once every 3 weeks on Day 1 of each cycle
Tislelizumab: Tislelizumab 200 mg administered intravenously once every 3 weeks on Day 1 of each cycle
Concurrent Chemoradiotherapy: Cisplatin/Carboplatin: Either cisplatin 75 milligrams/meters squared (mg/m2) administered intravenously once every 3 weeks on Day 1 of each cycle for 4 cycles or carboplatin at a dose of area under the curve (AUC) 5 administered intravenously once every 3 weeks on Day 1 of each cycle for 4 cycles.
Etoposide: (100 mg/m2) administered intravenously on Days 1, 2, and 3 of each cycle for 4 cycles
Thoracic radiation therapy (TRT): once daily fractions for 6 to 7 weeks for a total dose of 60 to 70 units of absorbed dose of ionizing radiation (Gy)
|
Arm B: Tislelizumab
n=42 Participants
Tislelizumab combined with cCRT (at the investigator's discretion) for 4 cycles, followed by tislelizumab alone
Tislelizumab: Tislelizumab 200 mg administered intravenously once every 3 weeks on Day 1 of each cycle
Concurrent Chemoradiotherapy: Cisplatin/Carboplatin: Either cisplatin 75 milligrams/meters squared (mg/m2) administered intravenously once every 3 weeks on Day 1 of each cycle for 4 cycles or carboplatin at a dose of area under the curve (AUC) 5 administered intravenously once every 3 weeks on Day 1 of each cycle for 4 cycles.
Etoposide: (100 mg/m2) administered intravenously on Days 1, 2, and 3 of each cycle for 4 cycles
Thoracic radiation therapy (TRT): once daily fractions for 6 to 7 weeks for a total dose of 60 to 70 units of absorbed dose of ionizing radiation (Gy)
|
Arm C: Concurrent Chemoradiotherapy (cCRT)
n=43 Participants
cCRT only for 4 cycles at the investigator's discretion
Concurrent Chemoradiotherapy: Cisplatin/Carboplatin: Either cisplatin 75 milligrams/meters squared (mg/m2) administered intravenously once every 3 weeks on Day 1 of each cycle for 4 cycles or carboplatin at a dose of area under the curve (AUC) 5 administered intravenously once every 3 weeks on Day 1 of each cycle for 4 cycles.
Etoposide: (100 mg/m2) administered intravenously on Days 1, 2, and 3 of each cycle for 4 cycles
Thoracic radiation therapy (TRT): once daily fractions for 6 to 7 weeks for a total dose of 60 to 70 units of absorbed dose of ionizing radiation (Gy)
|
|---|---|---|---|
|
Overall Response Rate (ORR)
|
85.4 percentage of participants
Interval 70.8 to 94.4
|
88.1 percentage of participants
Interval 74.4 to 96.0
|
76.7 percentage of participants
Interval 61.4 to 88.2
|
SECONDARY outcome
Timeframe: Up to approximately 2 yearsPopulation: The PD-L1 Analysis Set includes all patients who have at least 1 evaluable PD-L1 measurement expressed by Tumor Area Percentage (TAP).
defined as the percentage of participants who had CR or partial response (PR) as assessed by the investigator per RECIST v1.1
Outcome measures
| Measure |
Arm A: Ociperlimab + Tislelizumab
n=30 Participants
Ociperlimab plus tislelizumab combined with cCRT (at the investigator's discretion) for 4 cycles (each cycle is 28 days), followed by ociperlimab plus tislelizumab
Ociperlimab: Ociperlimab 900 milligrams (mg) administered intravenously once every 3 weeks on Day 1 of each cycle
Tislelizumab: Tislelizumab 200 mg administered intravenously once every 3 weeks on Day 1 of each cycle
Concurrent Chemoradiotherapy: Cisplatin/Carboplatin: Either cisplatin 75 milligrams/meters squared (mg/m2) administered intravenously once every 3 weeks on Day 1 of each cycle for 4 cycles or carboplatin at a dose of area under the curve (AUC) 5 administered intravenously once every 3 weeks on Day 1 of each cycle for 4 cycles.
Etoposide: (100 mg/m2) administered intravenously on Days 1, 2, and 3 of each cycle for 4 cycles
Thoracic radiation therapy (TRT): once daily fractions for 6 to 7 weeks for a total dose of 60 to 70 units of absorbed dose of ionizing radiation (Gy)
|
Arm B: Tislelizumab
n=28 Participants
Tislelizumab combined with cCRT (at the investigator's discretion) for 4 cycles, followed by tislelizumab alone
Tislelizumab: Tislelizumab 200 mg administered intravenously once every 3 weeks on Day 1 of each cycle
Concurrent Chemoradiotherapy: Cisplatin/Carboplatin: Either cisplatin 75 milligrams/meters squared (mg/m2) administered intravenously once every 3 weeks on Day 1 of each cycle for 4 cycles or carboplatin at a dose of area under the curve (AUC) 5 administered intravenously once every 3 weeks on Day 1 of each cycle for 4 cycles.
Etoposide: (100 mg/m2) administered intravenously on Days 1, 2, and 3 of each cycle for 4 cycles
Thoracic radiation therapy (TRT): once daily fractions for 6 to 7 weeks for a total dose of 60 to 70 units of absorbed dose of ionizing radiation (Gy)
|
Arm C: Concurrent Chemoradiotherapy (cCRT)
n=32 Participants
cCRT only for 4 cycles at the investigator's discretion
Concurrent Chemoradiotherapy: Cisplatin/Carboplatin: Either cisplatin 75 milligrams/meters squared (mg/m2) administered intravenously once every 3 weeks on Day 1 of each cycle for 4 cycles or carboplatin at a dose of area under the curve (AUC) 5 administered intravenously once every 3 weeks on Day 1 of each cycle for 4 cycles.
Etoposide: (100 mg/m2) administered intravenously on Days 1, 2, and 3 of each cycle for 4 cycles
Thoracic radiation therapy (TRT): once daily fractions for 6 to 7 weeks for a total dose of 60 to 70 units of absorbed dose of ionizing radiation (Gy)
|
|---|---|---|---|
|
Overall Response Rate (ORR) in the Programmed Death-Ligand 1 (PD-L1) Analysis Set
PD-L1 Expression in TAP ( >=1%)
|
85.7 percentage of participants
Interval 57.2 to 98.2
|
94.1 percentage of participants
Interval 71.3 to 99.9
|
76.5 percentage of participants
Interval 50.1 to 93.2
|
|
Overall Response Rate (ORR) in the Programmed Death-Ligand 1 (PD-L1) Analysis Set
PD-L1 Expression in TAP (<1%)
|
93.8 percentage of participants
Interval 69.8 to 99.8
|
81.8 percentage of participants
Interval 48.2 to 97.7
|
86.7 percentage of participants
Interval 59.5 to 98.3
|
SECONDARY outcome
Timeframe: Up to approximately 2 yearsPopulation: The TIGIT Analysis Set includes all patients who have at least 1 evaluable TIGIT measurement expressed by Immune Cells (IC) percentage.
defined as the percentage of participants who had CR or partial response (PR) as assessed by the investigator per RECIST v1.1
Outcome measures
| Measure |
Arm A: Ociperlimab + Tislelizumab
n=33 Participants
Ociperlimab plus tislelizumab combined with cCRT (at the investigator's discretion) for 4 cycles (each cycle is 28 days), followed by ociperlimab plus tislelizumab
Ociperlimab: Ociperlimab 900 milligrams (mg) administered intravenously once every 3 weeks on Day 1 of each cycle
Tislelizumab: Tislelizumab 200 mg administered intravenously once every 3 weeks on Day 1 of each cycle
Concurrent Chemoradiotherapy: Cisplatin/Carboplatin: Either cisplatin 75 milligrams/meters squared (mg/m2) administered intravenously once every 3 weeks on Day 1 of each cycle for 4 cycles or carboplatin at a dose of area under the curve (AUC) 5 administered intravenously once every 3 weeks on Day 1 of each cycle for 4 cycles.
Etoposide: (100 mg/m2) administered intravenously on Days 1, 2, and 3 of each cycle for 4 cycles
Thoracic radiation therapy (TRT): once daily fractions for 6 to 7 weeks for a total dose of 60 to 70 units of absorbed dose of ionizing radiation (Gy)
|
Arm B: Tislelizumab
n=32 Participants
Tislelizumab combined with cCRT (at the investigator's discretion) for 4 cycles, followed by tislelizumab alone
Tislelizumab: Tislelizumab 200 mg administered intravenously once every 3 weeks on Day 1 of each cycle
Concurrent Chemoradiotherapy: Cisplatin/Carboplatin: Either cisplatin 75 milligrams/meters squared (mg/m2) administered intravenously once every 3 weeks on Day 1 of each cycle for 4 cycles or carboplatin at a dose of area under the curve (AUC) 5 administered intravenously once every 3 weeks on Day 1 of each cycle for 4 cycles.
Etoposide: (100 mg/m2) administered intravenously on Days 1, 2, and 3 of each cycle for 4 cycles
Thoracic radiation therapy (TRT): once daily fractions for 6 to 7 weeks for a total dose of 60 to 70 units of absorbed dose of ionizing radiation (Gy)
|
Arm C: Concurrent Chemoradiotherapy (cCRT)
n=35 Participants
cCRT only for 4 cycles at the investigator's discretion
Concurrent Chemoradiotherapy: Cisplatin/Carboplatin: Either cisplatin 75 milligrams/meters squared (mg/m2) administered intravenously once every 3 weeks on Day 1 of each cycle for 4 cycles or carboplatin at a dose of area under the curve (AUC) 5 administered intravenously once every 3 weeks on Day 1 of each cycle for 4 cycles.
Etoposide: (100 mg/m2) administered intravenously on Days 1, 2, and 3 of each cycle for 4 cycles
Thoracic radiation therapy (TRT): once daily fractions for 6 to 7 weeks for a total dose of 60 to 70 units of absorbed dose of ionizing radiation (Gy)
|
|---|---|---|---|
|
Overall Response Rate (ORR) in the T Cell Immunoreceptor With Immunoglobulin and ITIM Domain (TIGIT) Analysis Set
TIGIT Expression Level in IC (>=1%)
|
88.9 percentage of participants
Interval 65.3 to 98.6
|
88.0 percentage of participants
Interval 68.8 to 97.5
|
93.8 percentage of participants
Interval 69.8 to 99.8
|
|
Overall Response Rate (ORR) in the T Cell Immunoreceptor With Immunoglobulin and ITIM Domain (TIGIT) Analysis Set
TIGIT Expression Level in IC (<1%)
|
86.7 percentage of participants
Interval 59.5 to 98.3
|
100.0 percentage of participants
Interval 59.0 to 100.0
|
68.4 percentage of participants
Interval 43.4 to 84.4
|
SECONDARY outcome
Timeframe: Up to approximately 2 yearsPopulation: The ITT analysis set included all randomized participants; only participants with an objective response (CR or PR) were included in this analysis
defined as the time from the date of the first occurrence of a documented objective response to the date of documented disease progression as assessed by the investigator per RECIST v1.1 or death from any cause (whichever occurs first)
Outcome measures
| Measure |
Arm A: Ociperlimab + Tislelizumab
n=35 Participants
Ociperlimab plus tislelizumab combined with cCRT (at the investigator's discretion) for 4 cycles (each cycle is 28 days), followed by ociperlimab plus tislelizumab
Ociperlimab: Ociperlimab 900 milligrams (mg) administered intravenously once every 3 weeks on Day 1 of each cycle
Tislelizumab: Tislelizumab 200 mg administered intravenously once every 3 weeks on Day 1 of each cycle
Concurrent Chemoradiotherapy: Cisplatin/Carboplatin: Either cisplatin 75 milligrams/meters squared (mg/m2) administered intravenously once every 3 weeks on Day 1 of each cycle for 4 cycles or carboplatin at a dose of area under the curve (AUC) 5 administered intravenously once every 3 weeks on Day 1 of each cycle for 4 cycles.
Etoposide: (100 mg/m2) administered intravenously on Days 1, 2, and 3 of each cycle for 4 cycles
Thoracic radiation therapy (TRT): once daily fractions for 6 to 7 weeks for a total dose of 60 to 70 units of absorbed dose of ionizing radiation (Gy)
|
Arm B: Tislelizumab
n=37 Participants
Tislelizumab combined with cCRT (at the investigator's discretion) for 4 cycles, followed by tislelizumab alone
Tislelizumab: Tislelizumab 200 mg administered intravenously once every 3 weeks on Day 1 of each cycle
Concurrent Chemoradiotherapy: Cisplatin/Carboplatin: Either cisplatin 75 milligrams/meters squared (mg/m2) administered intravenously once every 3 weeks on Day 1 of each cycle for 4 cycles or carboplatin at a dose of area under the curve (AUC) 5 administered intravenously once every 3 weeks on Day 1 of each cycle for 4 cycles.
Etoposide: (100 mg/m2) administered intravenously on Days 1, 2, and 3 of each cycle for 4 cycles
Thoracic radiation therapy (TRT): once daily fractions for 6 to 7 weeks for a total dose of 60 to 70 units of absorbed dose of ionizing radiation (Gy)
|
Arm C: Concurrent Chemoradiotherapy (cCRT)
n=33 Participants
cCRT only for 4 cycles at the investigator's discretion
Concurrent Chemoradiotherapy: Cisplatin/Carboplatin: Either cisplatin 75 milligrams/meters squared (mg/m2) administered intravenously once every 3 weeks on Day 1 of each cycle for 4 cycles or carboplatin at a dose of area under the curve (AUC) 5 administered intravenously once every 3 weeks on Day 1 of each cycle for 4 cycles.
Etoposide: (100 mg/m2) administered intravenously on Days 1, 2, and 3 of each cycle for 4 cycles
Thoracic radiation therapy (TRT): once daily fractions for 6 to 7 weeks for a total dose of 60 to 70 units of absorbed dose of ionizing radiation (Gy)
|
|---|---|---|---|
|
Duration of Response (DOR)
|
10.1 Months
Interval 6.0 to
Not estimable due to insufficient number of participants with events
|
11.5 Months
Interval 6.9 to
Not estimable due to insufficient number of participants with events
|
8.2 Months
Interval 5.6 to
Not estimable due to insufficient number of participants with events
|
SECONDARY outcome
Timeframe: Up to approximately 2 yearsPopulation: The Intent-To-Treat (ITT) analysis set includes all randomized participants
Defined as the time from the date of randomization to the date of death due to any cause
Outcome measures
| Measure |
Arm A: Ociperlimab + Tislelizumab
n=41 Participants
Ociperlimab plus tislelizumab combined with cCRT (at the investigator's discretion) for 4 cycles (each cycle is 28 days), followed by ociperlimab plus tislelizumab
Ociperlimab: Ociperlimab 900 milligrams (mg) administered intravenously once every 3 weeks on Day 1 of each cycle
Tislelizumab: Tislelizumab 200 mg administered intravenously once every 3 weeks on Day 1 of each cycle
Concurrent Chemoradiotherapy: Cisplatin/Carboplatin: Either cisplatin 75 milligrams/meters squared (mg/m2) administered intravenously once every 3 weeks on Day 1 of each cycle for 4 cycles or carboplatin at a dose of area under the curve (AUC) 5 administered intravenously once every 3 weeks on Day 1 of each cycle for 4 cycles.
Etoposide: (100 mg/m2) administered intravenously on Days 1, 2, and 3 of each cycle for 4 cycles
Thoracic radiation therapy (TRT): once daily fractions for 6 to 7 weeks for a total dose of 60 to 70 units of absorbed dose of ionizing radiation (Gy)
|
Arm B: Tislelizumab
n=42 Participants
Tislelizumab combined with cCRT (at the investigator's discretion) for 4 cycles, followed by tislelizumab alone
Tislelizumab: Tislelizumab 200 mg administered intravenously once every 3 weeks on Day 1 of each cycle
Concurrent Chemoradiotherapy: Cisplatin/Carboplatin: Either cisplatin 75 milligrams/meters squared (mg/m2) administered intravenously once every 3 weeks on Day 1 of each cycle for 4 cycles or carboplatin at a dose of area under the curve (AUC) 5 administered intravenously once every 3 weeks on Day 1 of each cycle for 4 cycles.
Etoposide: (100 mg/m2) administered intravenously on Days 1, 2, and 3 of each cycle for 4 cycles
Thoracic radiation therapy (TRT): once daily fractions for 6 to 7 weeks for a total dose of 60 to 70 units of absorbed dose of ionizing radiation (Gy)
|
Arm C: Concurrent Chemoradiotherapy (cCRT)
n=43 Participants
cCRT only for 4 cycles at the investigator's discretion
Concurrent Chemoradiotherapy: Cisplatin/Carboplatin: Either cisplatin 75 milligrams/meters squared (mg/m2) administered intravenously once every 3 weeks on Day 1 of each cycle for 4 cycles or carboplatin at a dose of area under the curve (AUC) 5 administered intravenously once every 3 weeks on Day 1 of each cycle for 4 cycles.
Etoposide: (100 mg/m2) administered intravenously on Days 1, 2, and 3 of each cycle for 4 cycles
Thoracic radiation therapy (TRT): once daily fractions for 6 to 7 weeks for a total dose of 60 to 70 units of absorbed dose of ionizing radiation (Gy)
|
|---|---|---|---|
|
Overall Survival (OS) in the ITT Analysis Set
|
NA months
Not estimable due to insufficient number of participants with events
|
NA months
Interval 19.8 to
Not estimable due to insufficient number of participants with events
|
NA months
Interval 20.0 to
Not estimable due to insufficient number of participants with events
|
SECONDARY outcome
Timeframe: Up to approximately 2 yearsPopulation: The PD-L1 Analysis Set includes all patients who have at least 1 evaluable PD-L1 measurement expressed by Tumor Area Percentage (TAP).
defined as the time from the date of randomization to the date of death due to any cause
Outcome measures
| Measure |
Arm A: Ociperlimab + Tislelizumab
n=30 Participants
Ociperlimab plus tislelizumab combined with cCRT (at the investigator's discretion) for 4 cycles (each cycle is 28 days), followed by ociperlimab plus tislelizumab
Ociperlimab: Ociperlimab 900 milligrams (mg) administered intravenously once every 3 weeks on Day 1 of each cycle
Tislelizumab: Tislelizumab 200 mg administered intravenously once every 3 weeks on Day 1 of each cycle
Concurrent Chemoradiotherapy: Cisplatin/Carboplatin: Either cisplatin 75 milligrams/meters squared (mg/m2) administered intravenously once every 3 weeks on Day 1 of each cycle for 4 cycles or carboplatin at a dose of area under the curve (AUC) 5 administered intravenously once every 3 weeks on Day 1 of each cycle for 4 cycles.
Etoposide: (100 mg/m2) administered intravenously on Days 1, 2, and 3 of each cycle for 4 cycles
Thoracic radiation therapy (TRT): once daily fractions for 6 to 7 weeks for a total dose of 60 to 70 units of absorbed dose of ionizing radiation (Gy)
|
Arm B: Tislelizumab
n=28 Participants
Tislelizumab combined with cCRT (at the investigator's discretion) for 4 cycles, followed by tislelizumab alone
Tislelizumab: Tislelizumab 200 mg administered intravenously once every 3 weeks on Day 1 of each cycle
Concurrent Chemoradiotherapy: Cisplatin/Carboplatin: Either cisplatin 75 milligrams/meters squared (mg/m2) administered intravenously once every 3 weeks on Day 1 of each cycle for 4 cycles or carboplatin at a dose of area under the curve (AUC) 5 administered intravenously once every 3 weeks on Day 1 of each cycle for 4 cycles.
Etoposide: (100 mg/m2) administered intravenously on Days 1, 2, and 3 of each cycle for 4 cycles
Thoracic radiation therapy (TRT): once daily fractions for 6 to 7 weeks for a total dose of 60 to 70 units of absorbed dose of ionizing radiation (Gy)
|
Arm C: Concurrent Chemoradiotherapy (cCRT)
n=32 Participants
cCRT only for 4 cycles at the investigator's discretion
Concurrent Chemoradiotherapy: Cisplatin/Carboplatin: Either cisplatin 75 milligrams/meters squared (mg/m2) administered intravenously once every 3 weeks on Day 1 of each cycle for 4 cycles or carboplatin at a dose of area under the curve (AUC) 5 administered intravenously once every 3 weeks on Day 1 of each cycle for 4 cycles.
Etoposide: (100 mg/m2) administered intravenously on Days 1, 2, and 3 of each cycle for 4 cycles
Thoracic radiation therapy (TRT): once daily fractions for 6 to 7 weeks for a total dose of 60 to 70 units of absorbed dose of ionizing radiation (Gy)
|
|---|---|---|---|
|
Overall Survival (OS) in the PD-L1 Analysis Set
PD-L1 Expression in TAP (>=1%)
|
NA months
Interval 12.2 to
the median OS was not reached in the PD-L1 expression subgroups due to too few events to draw any meaningful conclusions
|
NA months
Interval 17.6 to
the median OS was not reached in the PD-L1 expression subgroups due to too few events to draw any meaningful conclusions
|
NA months
Interval 16.5 to
the median OS was not reached in the PD-L1 expression subgroups due to too few events to draw any meaningful conclusions
|
|
Overall Survival (OS) in the PD-L1 Analysis Set
PD-L1 Expression in TAP (<1%)
|
NA months
Interval 13.1 to
the median OS was not reached in the PD-L1 expression subgroups due to too few events to draw any meaningful conclusions
|
NA months
Interval 7.3 to
the median OS was not reached in the PD-L1 expression subgroups due to too few events to draw any meaningful conclusions
|
NA months
Interval 13.3 to
the median OS was not reached in the PD-L1 expression subgroups due to too few events to draw any meaningful conclusions
|
SECONDARY outcome
Timeframe: Up to approximately 2 yearsPopulation: The TIGIT Analysis Set includes all patients who have at least 1 evaluable TIGIT measurement expressed by immune cells percentage.
defined as the time from the date of randomization to the date of death due to any cause
Outcome measures
| Measure |
Arm A: Ociperlimab + Tislelizumab
n=33 Participants
Ociperlimab plus tislelizumab combined with cCRT (at the investigator's discretion) for 4 cycles (each cycle is 28 days), followed by ociperlimab plus tislelizumab
Ociperlimab: Ociperlimab 900 milligrams (mg) administered intravenously once every 3 weeks on Day 1 of each cycle
Tislelizumab: Tislelizumab 200 mg administered intravenously once every 3 weeks on Day 1 of each cycle
Concurrent Chemoradiotherapy: Cisplatin/Carboplatin: Either cisplatin 75 milligrams/meters squared (mg/m2) administered intravenously once every 3 weeks on Day 1 of each cycle for 4 cycles or carboplatin at a dose of area under the curve (AUC) 5 administered intravenously once every 3 weeks on Day 1 of each cycle for 4 cycles.
Etoposide: (100 mg/m2) administered intravenously on Days 1, 2, and 3 of each cycle for 4 cycles
Thoracic radiation therapy (TRT): once daily fractions for 6 to 7 weeks for a total dose of 60 to 70 units of absorbed dose of ionizing radiation (Gy)
|
Arm B: Tislelizumab
n=32 Participants
Tislelizumab combined with cCRT (at the investigator's discretion) for 4 cycles, followed by tislelizumab alone
Tislelizumab: Tislelizumab 200 mg administered intravenously once every 3 weeks on Day 1 of each cycle
Concurrent Chemoradiotherapy: Cisplatin/Carboplatin: Either cisplatin 75 milligrams/meters squared (mg/m2) administered intravenously once every 3 weeks on Day 1 of each cycle for 4 cycles or carboplatin at a dose of area under the curve (AUC) 5 administered intravenously once every 3 weeks on Day 1 of each cycle for 4 cycles.
Etoposide: (100 mg/m2) administered intravenously on Days 1, 2, and 3 of each cycle for 4 cycles
Thoracic radiation therapy (TRT): once daily fractions for 6 to 7 weeks for a total dose of 60 to 70 units of absorbed dose of ionizing radiation (Gy)
|
Arm C: Concurrent Chemoradiotherapy (cCRT)
n=35 Participants
cCRT only for 4 cycles at the investigator's discretion
Concurrent Chemoradiotherapy: Cisplatin/Carboplatin: Either cisplatin 75 milligrams/meters squared (mg/m2) administered intravenously once every 3 weeks on Day 1 of each cycle for 4 cycles or carboplatin at a dose of area under the curve (AUC) 5 administered intravenously once every 3 weeks on Day 1 of each cycle for 4 cycles.
Etoposide: (100 mg/m2) administered intravenously on Days 1, 2, and 3 of each cycle for 4 cycles
Thoracic radiation therapy (TRT): once daily fractions for 6 to 7 weeks for a total dose of 60 to 70 units of absorbed dose of ionizing radiation (Gy)
|
|---|---|---|---|
|
Overall Survival (OS) in the TIGIT Analysis Set
TIGIT Expression Level in IC (>=1%)
|
NA months
the median OS was not reached in the TIGIT expression subgroups, due to too few events to draw any meaningful conclusions
|
NA months
the median OS was not reached in the TIGIT expression subgroups, due to too few events to draw any meaningful conclusions
|
NA months
Interval 20.0 to
the median OS was not reached in the TIGIT expression subgroups, due to too few events to draw any meaningful conclusions
|
|
Overall Survival (OS) in the TIGIT Analysis Set
TIGIT Expression Level in IC (<1%)
|
NA months
Interval 12.0 to
the median OS was not reached in the TIGIT expression subgroups, due to too few events to draw any meaningful conclusions
|
NA months
Interval 17.6 to
the median OS was not reached in the TIGIT expression subgroups, due to too few events to draw any meaningful conclusions
|
NA months
Interval 13.3 to
the median OS was not reached in the TIGIT expression subgroups, due to too few events to draw any meaningful conclusions
|
SECONDARY outcome
Timeframe: Up to approximately 2 yearsPopulation: The Intent-To-Treat (ITT) analysis set includes all randomized participants
defined as the time from the date of randomization to the date of the first documented distant metastasis as assessed by the investigator per RECIST v1.1 or death from any cause (whichever occurs first)
Outcome measures
| Measure |
Arm A: Ociperlimab + Tislelizumab
n=41 Participants
Ociperlimab plus tislelizumab combined with cCRT (at the investigator's discretion) for 4 cycles (each cycle is 28 days), followed by ociperlimab plus tislelizumab
Ociperlimab: Ociperlimab 900 milligrams (mg) administered intravenously once every 3 weeks on Day 1 of each cycle
Tislelizumab: Tislelizumab 200 mg administered intravenously once every 3 weeks on Day 1 of each cycle
Concurrent Chemoradiotherapy: Cisplatin/Carboplatin: Either cisplatin 75 milligrams/meters squared (mg/m2) administered intravenously once every 3 weeks on Day 1 of each cycle for 4 cycles or carboplatin at a dose of area under the curve (AUC) 5 administered intravenously once every 3 weeks on Day 1 of each cycle for 4 cycles.
Etoposide: (100 mg/m2) administered intravenously on Days 1, 2, and 3 of each cycle for 4 cycles
Thoracic radiation therapy (TRT): once daily fractions for 6 to 7 weeks for a total dose of 60 to 70 units of absorbed dose of ionizing radiation (Gy)
|
Arm B: Tislelizumab
n=42 Participants
Tislelizumab combined with cCRT (at the investigator's discretion) for 4 cycles, followed by tislelizumab alone
Tislelizumab: Tislelizumab 200 mg administered intravenously once every 3 weeks on Day 1 of each cycle
Concurrent Chemoradiotherapy: Cisplatin/Carboplatin: Either cisplatin 75 milligrams/meters squared (mg/m2) administered intravenously once every 3 weeks on Day 1 of each cycle for 4 cycles or carboplatin at a dose of area under the curve (AUC) 5 administered intravenously once every 3 weeks on Day 1 of each cycle for 4 cycles.
Etoposide: (100 mg/m2) administered intravenously on Days 1, 2, and 3 of each cycle for 4 cycles
Thoracic radiation therapy (TRT): once daily fractions for 6 to 7 weeks for a total dose of 60 to 70 units of absorbed dose of ionizing radiation (Gy)
|
Arm C: Concurrent Chemoradiotherapy (cCRT)
n=43 Participants
cCRT only for 4 cycles at the investigator's discretion
Concurrent Chemoradiotherapy: Cisplatin/Carboplatin: Either cisplatin 75 milligrams/meters squared (mg/m2) administered intravenously once every 3 weeks on Day 1 of each cycle for 4 cycles or carboplatin at a dose of area under the curve (AUC) 5 administered intravenously once every 3 weeks on Day 1 of each cycle for 4 cycles.
Etoposide: (100 mg/m2) administered intravenously on Days 1, 2, and 3 of each cycle for 4 cycles
Thoracic radiation therapy (TRT): once daily fractions for 6 to 7 weeks for a total dose of 60 to 70 units of absorbed dose of ionizing radiation (Gy)
|
|---|---|---|---|
|
Distant Metastasis-free Survival (DMFS)
|
17.9 months
Interval 9.7 to
Not estimable due to insufficient number of participants with events
|
15.3 months
Interval 9.8 to
Not estimable due to insufficient number of participants with events
|
20.0 months
Interval 8.6 to
Not estimable due to insufficient number of participants with events
|
SECONDARY outcome
Timeframe: Up to approximately 2 yearsPopulation: The PD-L1 Analysis Set includes all patients who have at least 1 evaluable PD-L1 measurement expressed by Tumor Area Percentage (TAP).
defined as the time from the date of randomization to the date of the first documented disease progression as determined by the investigator per RECIST v1.1 or death from any cause (whichever occurs first),
Outcome measures
| Measure |
Arm A: Ociperlimab + Tislelizumab
n=30 Participants
Ociperlimab plus tislelizumab combined with cCRT (at the investigator's discretion) for 4 cycles (each cycle is 28 days), followed by ociperlimab plus tislelizumab
Ociperlimab: Ociperlimab 900 milligrams (mg) administered intravenously once every 3 weeks on Day 1 of each cycle
Tislelizumab: Tislelizumab 200 mg administered intravenously once every 3 weeks on Day 1 of each cycle
Concurrent Chemoradiotherapy: Cisplatin/Carboplatin: Either cisplatin 75 milligrams/meters squared (mg/m2) administered intravenously once every 3 weeks on Day 1 of each cycle for 4 cycles or carboplatin at a dose of area under the curve (AUC) 5 administered intravenously once every 3 weeks on Day 1 of each cycle for 4 cycles.
Etoposide: (100 mg/m2) administered intravenously on Days 1, 2, and 3 of each cycle for 4 cycles
Thoracic radiation therapy (TRT): once daily fractions for 6 to 7 weeks for a total dose of 60 to 70 units of absorbed dose of ionizing radiation (Gy)
|
Arm B: Tislelizumab
n=28 Participants
Tislelizumab combined with cCRT (at the investigator's discretion) for 4 cycles, followed by tislelizumab alone
Tislelizumab: Tislelizumab 200 mg administered intravenously once every 3 weeks on Day 1 of each cycle
Concurrent Chemoradiotherapy: Cisplatin/Carboplatin: Either cisplatin 75 milligrams/meters squared (mg/m2) administered intravenously once every 3 weeks on Day 1 of each cycle for 4 cycles or carboplatin at a dose of area under the curve (AUC) 5 administered intravenously once every 3 weeks on Day 1 of each cycle for 4 cycles.
Etoposide: (100 mg/m2) administered intravenously on Days 1, 2, and 3 of each cycle for 4 cycles
Thoracic radiation therapy (TRT): once daily fractions for 6 to 7 weeks for a total dose of 60 to 70 units of absorbed dose of ionizing radiation (Gy)
|
Arm C: Concurrent Chemoradiotherapy (cCRT)
n=32 Participants
cCRT only for 4 cycles at the investigator's discretion
Concurrent Chemoradiotherapy: Cisplatin/Carboplatin: Either cisplatin 75 milligrams/meters squared (mg/m2) administered intravenously once every 3 weeks on Day 1 of each cycle for 4 cycles or carboplatin at a dose of area under the curve (AUC) 5 administered intravenously once every 3 weeks on Day 1 of each cycle for 4 cycles.
Etoposide: (100 mg/m2) administered intravenously on Days 1, 2, and 3 of each cycle for 4 cycles
Thoracic radiation therapy (TRT): once daily fractions for 6 to 7 weeks for a total dose of 60 to 70 units of absorbed dose of ionizing radiation (Gy)
|
|---|---|---|---|
|
PFS in the PD-L1 Analysis Set
PD-L1 Expression in TAP ( >=1%)
|
12.6 months
Interval 7.8 to
Not estimable due to insufficient number of participants with events
|
15.0 months
Interval 8.5 to
Not estimable due to insufficient number of participants with events
|
11.1 months
Interval 8.1 to
Not estimable due to insufficient number of participants with events
|
|
PFS in the PD-L1 Analysis Set
PD-L1 Expression in TAP (<1%)
|
10.3 months
Interval 5.7 to
Not estimable due to insufficient number of participants with events
|
14.8 months
Interval 4.0 to
Not estimable due to insufficient number of participants with events
|
14.4 months
Interval 7.9 to
Not estimable due to insufficient number of participants with events
|
SECONDARY outcome
Timeframe: Up to approximately 2 yearsPopulation: The TIGIT Analysis Set includes all patients who have at least 1 evaluable TIGIT measurement expressed by immune cells percentage.
defined as the time from the date of randomization to the date of the first documented disease progression as determined by the investigator per RECIST v1.1 or death from any cause (whichever occurs first),
Outcome measures
| Measure |
Arm A: Ociperlimab + Tislelizumab
n=33 Participants
Ociperlimab plus tislelizumab combined with cCRT (at the investigator's discretion) for 4 cycles (each cycle is 28 days), followed by ociperlimab plus tislelizumab
Ociperlimab: Ociperlimab 900 milligrams (mg) administered intravenously once every 3 weeks on Day 1 of each cycle
Tislelizumab: Tislelizumab 200 mg administered intravenously once every 3 weeks on Day 1 of each cycle
Concurrent Chemoradiotherapy: Cisplatin/Carboplatin: Either cisplatin 75 milligrams/meters squared (mg/m2) administered intravenously once every 3 weeks on Day 1 of each cycle for 4 cycles or carboplatin at a dose of area under the curve (AUC) 5 administered intravenously once every 3 weeks on Day 1 of each cycle for 4 cycles.
Etoposide: (100 mg/m2) administered intravenously on Days 1, 2, and 3 of each cycle for 4 cycles
Thoracic radiation therapy (TRT): once daily fractions for 6 to 7 weeks for a total dose of 60 to 70 units of absorbed dose of ionizing radiation (Gy)
|
Arm B: Tislelizumab
n=32 Participants
Tislelizumab combined with cCRT (at the investigator's discretion) for 4 cycles, followed by tislelizumab alone
Tislelizumab: Tislelizumab 200 mg administered intravenously once every 3 weeks on Day 1 of each cycle
Concurrent Chemoradiotherapy: Cisplatin/Carboplatin: Either cisplatin 75 milligrams/meters squared (mg/m2) administered intravenously once every 3 weeks on Day 1 of each cycle for 4 cycles or carboplatin at a dose of area under the curve (AUC) 5 administered intravenously once every 3 weeks on Day 1 of each cycle for 4 cycles.
Etoposide: (100 mg/m2) administered intravenously on Days 1, 2, and 3 of each cycle for 4 cycles
Thoracic radiation therapy (TRT): once daily fractions for 6 to 7 weeks for a total dose of 60 to 70 units of absorbed dose of ionizing radiation (Gy)
|
Arm C: Concurrent Chemoradiotherapy (cCRT)
n=35 Participants
cCRT only for 4 cycles at the investigator's discretion
Concurrent Chemoradiotherapy: Cisplatin/Carboplatin: Either cisplatin 75 milligrams/meters squared (mg/m2) administered intravenously once every 3 weeks on Day 1 of each cycle for 4 cycles or carboplatin at a dose of area under the curve (AUC) 5 administered intravenously once every 3 weeks on Day 1 of each cycle for 4 cycles.
Etoposide: (100 mg/m2) administered intravenously on Days 1, 2, and 3 of each cycle for 4 cycles
Thoracic radiation therapy (TRT): once daily fractions for 6 to 7 weeks for a total dose of 60 to 70 units of absorbed dose of ionizing radiation (Gy)
|
|---|---|---|---|
|
PFS in the TIGIT Analysis Set
TIGIT Expression Level in IC (>=1%)
|
17.9 months
Interval 9.5 to
Not estimable due to insufficient number of participants with events
|
14.3 months
Interval 7.1 to
Not estimable due to insufficient number of participants with events
|
11.2 months
Interval 8.3 to
Not estimable due to insufficient number of participants with events
|
|
PFS in the TIGIT Analysis Set
TIGIT Expression Level in IC (<1%)
|
8.7 months
Interval 5.5 to 12.6
|
NA months
Interval 8.3 to
Not estimable due to insufficient number of participants with events
|
14.4 months
Interval 7.2 to
Not estimable due to insufficient number of participants with events
|
SECONDARY outcome
Timeframe: From the first dose of study drug(s) to 30 days after the last dose; up to approximately 2 yearsPopulation: The Safety Analysis Set includes all patients who have received \>= 1 dose of any component of study drug.
Number of participants with treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), v4.03
Outcome measures
| Measure |
Arm A: Ociperlimab + Tislelizumab
n=41 Participants
Ociperlimab plus tislelizumab combined with cCRT (at the investigator's discretion) for 4 cycles (each cycle is 28 days), followed by ociperlimab plus tislelizumab
Ociperlimab: Ociperlimab 900 milligrams (mg) administered intravenously once every 3 weeks on Day 1 of each cycle
Tislelizumab: Tislelizumab 200 mg administered intravenously once every 3 weeks on Day 1 of each cycle
Concurrent Chemoradiotherapy: Cisplatin/Carboplatin: Either cisplatin 75 milligrams/meters squared (mg/m2) administered intravenously once every 3 weeks on Day 1 of each cycle for 4 cycles or carboplatin at a dose of area under the curve (AUC) 5 administered intravenously once every 3 weeks on Day 1 of each cycle for 4 cycles.
Etoposide: (100 mg/m2) administered intravenously on Days 1, 2, and 3 of each cycle for 4 cycles
Thoracic radiation therapy (TRT): once daily fractions for 6 to 7 weeks for a total dose of 60 to 70 units of absorbed dose of ionizing radiation (Gy)
|
Arm B: Tislelizumab
n=42 Participants
Tislelizumab combined with cCRT (at the investigator's discretion) for 4 cycles, followed by tislelizumab alone
Tislelizumab: Tislelizumab 200 mg administered intravenously once every 3 weeks on Day 1 of each cycle
Concurrent Chemoradiotherapy: Cisplatin/Carboplatin: Either cisplatin 75 milligrams/meters squared (mg/m2) administered intravenously once every 3 weeks on Day 1 of each cycle for 4 cycles or carboplatin at a dose of area under the curve (AUC) 5 administered intravenously once every 3 weeks on Day 1 of each cycle for 4 cycles.
Etoposide: (100 mg/m2) administered intravenously on Days 1, 2, and 3 of each cycle for 4 cycles
Thoracic radiation therapy (TRT): once daily fractions for 6 to 7 weeks for a total dose of 60 to 70 units of absorbed dose of ionizing radiation (Gy)
|
Arm C: Concurrent Chemoradiotherapy (cCRT)
n=43 Participants
cCRT only for 4 cycles at the investigator's discretion
Concurrent Chemoradiotherapy: Cisplatin/Carboplatin: Either cisplatin 75 milligrams/meters squared (mg/m2) administered intravenously once every 3 weeks on Day 1 of each cycle for 4 cycles or carboplatin at a dose of area under the curve (AUC) 5 administered intravenously once every 3 weeks on Day 1 of each cycle for 4 cycles.
Etoposide: (100 mg/m2) administered intravenously on Days 1, 2, and 3 of each cycle for 4 cycles
Thoracic radiation therapy (TRT): once daily fractions for 6 to 7 weeks for a total dose of 60 to 70 units of absorbed dose of ionizing radiation (Gy)
|
|---|---|---|---|
|
Number of Participants Experiencing Adverse Events (AEs)
Number of Participants with at least one TEAE
|
41 Participants
|
42 Participants
|
43 Participants
|
|
Number of Participants Experiencing Adverse Events (AEs)
Number of participants with at least one SAE
|
25 Participants
|
20 Participants
|
12 Participants
|
Adverse Events
Arm A: Ociperlimab + Tislelizumab
Serious events: 25 serious events
Other events: 41 other events
Deaths: 12 deaths
Arm B: Tislelizumab
Serious events: 20 serious events
Other events: 42 other events
Deaths: 13 deaths
Arm C: Concurrent Chemoradiotherapy (cCRT)
Serious events: 12 serious events
Other events: 43 other events
Deaths: 14 deaths
Serious adverse events
| Measure |
Arm A: Ociperlimab + Tislelizumab
n=41 participants at risk
Ociperlimab plus tislelizumab combined with cCRT (at the investigator's discretion) for 4 cycles (each cycle is 28 days), followed by ociperlimab plus tislelizumab
|
Arm B: Tislelizumab
n=42 participants at risk
Tislelizumab combined with cCRT (at the investigator's discretion) for 4 cycles, followed by tislelizumab alone
|
Arm C: Concurrent Chemoradiotherapy (cCRT)
n=43 participants at risk
cCRT only for 4 cycles at the investigator's discretion
|
|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
4.9%
2/41 • Number of events 2 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 2 years
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
0.00%
0/42 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 2 years
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
2.3%
1/43 • Number of events 1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 2 years
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
0.00%
0/41 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 2 years
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
4.8%
2/42 • Number of events 3 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 2 years
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
0.00%
0/43 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 2 years
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
|
Cardiac disorders
Arteriosclerosis coronary artery
|
0.00%
0/41 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 2 years
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
2.4%
1/42 • Number of events 1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 2 years
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
0.00%
0/43 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 2 years
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
|
Cardiac disorders
Cardiac failure
|
0.00%
0/41 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 2 years
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
2.4%
1/42 • Number of events 1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 2 years
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
0.00%
0/43 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 2 years
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
|
Gastrointestinal disorders
Immune-mediated enterocolitis
|
2.4%
1/41 • Number of events 1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 2 years
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
0.00%
0/42 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 2 years
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
0.00%
0/43 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 2 years
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
|
Gastrointestinal disorders
Oesophageal fistula
|
0.00%
0/41 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 2 years
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
2.4%
1/42 • Number of events 1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 2 years
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
0.00%
0/43 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 2 years
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
|
Gastrointestinal disorders
Oesophageal perforation
|
2.4%
1/41 • Number of events 1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 2 years
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
0.00%
0/42 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 2 years
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
0.00%
0/43 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 2 years
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
|
Gastrointestinal disorders
Pancreatitis
|
0.00%
0/41 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 2 years
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
2.4%
1/42 • Number of events 1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 2 years
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
0.00%
0/43 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 2 years
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
|
Gastrointestinal disorders
Upper gastrointestinal haemorrhage
|
2.4%
1/41 • Number of events 1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 2 years
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
0.00%
0/42 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 2 years
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
0.00%
0/43 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 2 years
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
|
Gastrointestinal disorders
Vomiting
|
2.4%
1/41 • Number of events 1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 2 years
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
0.00%
0/42 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 2 years
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
0.00%
0/43 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 2 years
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
|
General disorders
Pyrexia
|
2.4%
1/41 • Number of events 1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 2 years
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
2.4%
1/42 • Number of events 1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 2 years
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
0.00%
0/43 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 2 years
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
|
Infections and infestations
COVID-19
|
0.00%
0/41 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 2 years
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
2.4%
1/42 • Number of events 1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 2 years
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
0.00%
0/43 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 2 years
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
|
Infections and infestations
COVID-19 pneumonia
|
2.4%
1/41 • Number of events 1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 2 years
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
0.00%
0/42 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 2 years
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
0.00%
0/43 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 2 years
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
|
Infections and infestations
Pneumonia
|
14.6%
6/41 • Number of events 6 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 2 years
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
7.1%
3/42 • Number of events 3 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 2 years
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
0.00%
0/43 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 2 years
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
|
Infections and infestations
Pneumonia bacterial
|
2.4%
1/41 • Number of events 1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 2 years
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
0.00%
0/42 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 2 years
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
0.00%
0/43 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 2 years
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
|
Infections and infestations
Sepsis
|
0.00%
0/41 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 2 years
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
0.00%
0/42 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 2 years
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
2.3%
1/43 • Number of events 1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 2 years
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
|
Infections and infestations
Septic shock
|
2.4%
1/41 • Number of events 1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 2 years
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
2.4%
1/42 • Number of events 1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 2 years
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
0.00%
0/43 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 2 years
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
|
Infections and infestations
Sinusitis
|
2.4%
1/41 • Number of events 1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 2 years
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
0.00%
0/42 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 2 years
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
0.00%
0/43 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 2 years
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
|
Injury, poisoning and procedural complications
Foreign body in gastrointestinal tract
|
0.00%
0/41 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 2 years
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
0.00%
0/42 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 2 years
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
2.3%
1/43 • Number of events 2 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 2 years
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
|
Injury, poisoning and procedural complications
Radiation oesophagitis
|
0.00%
0/41 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 2 years
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
7.1%
3/42 • Number of events 4 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 2 years
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
7.0%
3/43 • Number of events 3 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 2 years
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
|
Injury, poisoning and procedural complications
Radiation pneumonitis
|
7.3%
3/41 • Number of events 3 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 2 years
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
7.1%
3/42 • Number of events 3 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 2 years
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
2.3%
1/43 • Number of events 1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 2 years
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
|
Investigations
Lymphocyte count decreased
|
0.00%
0/41 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 2 years
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
2.4%
1/42 • Number of events 1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 2 years
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
0.00%
0/43 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 2 years
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
|
Investigations
Myocardial necrosis marker increased
|
2.4%
1/41 • Number of events 1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 2 years
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
0.00%
0/42 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 2 years
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
0.00%
0/43 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 2 years
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
|
Investigations
Neutrophil count decreased
|
12.2%
5/41 • Number of events 6 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 2 years
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
11.9%
5/42 • Number of events 5 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 2 years
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
7.0%
3/43 • Number of events 4 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 2 years
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
|
Investigations
Platelet count decreased
|
14.6%
6/41 • Number of events 6 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 2 years
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
7.1%
3/42 • Number of events 4 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 2 years
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
9.3%
4/43 • Number of events 5 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 2 years
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
|
Investigations
White blood cell count decreased
|
12.2%
5/41 • Number of events 6 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 2 years
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
4.8%
2/42 • Number of events 2 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 2 years
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
7.0%
3/43 • Number of events 3 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 2 years
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
2.4%
1/41 • Number of events 3 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 2 years
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
0.00%
0/42 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 2 years
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
0.00%
0/43 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 2 years
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
4.9%
2/41 • Number of events 2 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 2 years
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
0.00%
0/42 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 2 years
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
2.3%
1/43 • Number of events 1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 2 years
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
2.4%
1/41 • Number of events 1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 2 years
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
0.00%
0/42 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 2 years
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
0.00%
0/43 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 2 years
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
|
Musculoskeletal and connective tissue disorders
Rotator cuff syndrome
|
0.00%
0/41 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 2 years
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
2.4%
1/42 • Number of events 1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 2 years
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
0.00%
0/43 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 2 years
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
|
Nervous system disorders
Ataxia
|
2.4%
1/41 • Number of events 1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 2 years
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
0.00%
0/42 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 2 years
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
0.00%
0/43 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 2 years
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
|
Nervous system disorders
Immune-mediated optic neuritis
|
0.00%
0/41 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 2 years
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
2.4%
1/42 • Number of events 1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 2 years
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
0.00%
0/43 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 2 years
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
2.4%
1/41 • Number of events 1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 2 years
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
0.00%
0/42 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 2 years
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
0.00%
0/43 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 2 years
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
|
Respiratory, thoracic and mediastinal disorders
Immune-mediated lung disease
|
2.4%
1/41 • Number of events 1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 2 years
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
2.4%
1/42 • Number of events 1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 2 years
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
0.00%
0/43 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 2 years
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
|
Respiratory, thoracic and mediastinal disorders
Interstitial lung disease
|
2.4%
1/41 • Number of events 1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 2 years
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
0.00%
0/42 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 2 years
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
0.00%
0/43 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 2 years
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
9.8%
4/41 • Number of events 4 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 2 years
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
4.8%
2/42 • Number of events 2 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 2 years
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
2.3%
1/43 • Number of events 1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 2 years
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.00%
0/41 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 2 years
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
2.4%
1/42 • Number of events 1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 2 years
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
0.00%
0/43 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 2 years
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.00%
0/41 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 2 years
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
2.4%
1/42 • Number of events 1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 2 years
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
0.00%
0/43 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 2 years
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
Other adverse events
| Measure |
Arm A: Ociperlimab + Tislelizumab
n=41 participants at risk
Ociperlimab plus tislelizumab combined with cCRT (at the investigator's discretion) for 4 cycles (each cycle is 28 days), followed by ociperlimab plus tislelizumab
|
Arm B: Tislelizumab
n=42 participants at risk
Tislelizumab combined with cCRT (at the investigator's discretion) for 4 cycles, followed by tislelizumab alone
|
Arm C: Concurrent Chemoradiotherapy (cCRT)
n=43 participants at risk
cCRT only for 4 cycles at the investigator's discretion
|
|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
90.2%
37/41 • Number of events 72 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 2 years
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
90.5%
38/42 • Number of events 79 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 2 years
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
88.4%
38/43 • Number of events 48 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 2 years
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
|
Blood and lymphatic system disorders
Leukopenia
|
4.9%
2/41 • Number of events 4 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 2 years
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
7.1%
3/42 • Number of events 11 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 2 years
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
9.3%
4/43 • Number of events 14 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 2 years
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
|
Blood and lymphatic system disorders
Neutropenia
|
4.9%
2/41 • Number of events 4 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 2 years
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
4.8%
2/42 • Number of events 15 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 2 years
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
2.3%
1/43 • Number of events 2 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 2 years
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
7.3%
3/41 • Number of events 4 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 2 years
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
9.5%
4/42 • Number of events 10 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 2 years
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
0.00%
0/43 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 2 years
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
|
Cardiac disorders
Sinus tachycardia
|
0.00%
0/41 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 2 years
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
7.1%
3/42 • Number of events 4 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 2 years
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
0.00%
0/43 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 2 years
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
|
Cardiac disorders
Supraventricular tachycardia
|
0.00%
0/41 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 2 years
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
4.8%
2/42 • Number of events 2 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 2 years
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
2.3%
1/43 • Number of events 1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 2 years
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
|
Endocrine disorders
Hyperthyroidism
|
0.00%
0/41 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 2 years
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
9.5%
4/42 • Number of events 4 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 2 years
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
0.00%
0/43 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 2 years
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
|
Endocrine disorders
Hypothyroidism
|
12.2%
5/41 • Number of events 5 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 2 years
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
26.2%
11/42 • Number of events 11 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 2 years
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
0.00%
0/43 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 2 years
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
|
Gastrointestinal disorders
Abdominal distension
|
9.8%
4/41 • Number of events 4 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 2 years
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
2.4%
1/42 • Number of events 1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 2 years
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
2.3%
1/43 • Number of events 2 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 2 years
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
|
Gastrointestinal disorders
Abdominal pain
|
7.3%
3/41 • Number of events 3 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 2 years
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
4.8%
2/42 • Number of events 2 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 2 years
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
0.00%
0/43 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 2 years
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
9.8%
4/41 • Number of events 6 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 2 years
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
4.8%
2/42 • Number of events 2 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 2 years
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
0.00%
0/43 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 2 years
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
|
Gastrointestinal disorders
Constipation
|
58.5%
24/41 • Number of events 43 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 2 years
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
45.2%
19/42 • Number of events 35 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 2 years
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
30.2%
13/43 • Number of events 20 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 2 years
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
|
Gastrointestinal disorders
Diarrhoea
|
14.6%
6/41 • Number of events 6 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 2 years
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
11.9%
5/42 • Number of events 7 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 2 years
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
9.3%
4/43 • Number of events 6 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 2 years
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
|
Gastrointestinal disorders
Dyspepsia
|
9.8%
4/41 • Number of events 4 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 2 years
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
2.4%
1/42 • Number of events 1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 2 years
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
2.3%
1/43 • Number of events 1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 2 years
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
|
Gastrointestinal disorders
Dysphagia
|
9.8%
4/41 • Number of events 5 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 2 years
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
4.8%
2/42 • Number of events 2 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 2 years
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
16.3%
7/43 • Number of events 7 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 2 years
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
|
Gastrointestinal disorders
Eructation
|
0.00%
0/41 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 2 years
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
0.00%
0/42 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 2 years
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
4.7%
2/43 • Number of events 2 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 2 years
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
|
Gastrointestinal disorders
Gastric dilatation
|
0.00%
0/41 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 2 years
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
4.8%
2/42 • Number of events 2 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 2 years
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
0.00%
0/43 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 2 years
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
|
Gastrointestinal disorders
Gastritis
|
4.9%
2/41 • Number of events 2 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 2 years
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
0.00%
0/42 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 2 years
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
0.00%
0/43 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 2 years
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
2.4%
1/41 • Number of events 2 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 2 years
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
4.8%
2/42 • Number of events 2 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 2 years
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
4.7%
2/43 • Number of events 2 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 2 years
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
|
Gastrointestinal disorders
Nausea
|
82.9%
34/41 • Number of events 73 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 2 years
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
76.2%
32/42 • Number of events 81 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 2 years
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
65.1%
28/43 • Number of events 57 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 2 years
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
|
Gastrointestinal disorders
Reflux gastritis
|
0.00%
0/41 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 2 years
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
4.8%
2/42 • Number of events 3 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 2 years
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
0.00%
0/43 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 2 years
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
|
Gastrointestinal disorders
Toothache
|
4.9%
2/41 • Number of events 2 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 2 years
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
7.1%
3/42 • Number of events 3 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 2 years
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
4.7%
2/43 • Number of events 2 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 2 years
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
|
Gastrointestinal disorders
Vomiting
|
53.7%
22/41 • Number of events 40 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 2 years
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
69.0%
29/42 • Number of events 67 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 2 years
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
34.9%
15/43 • Number of events 33 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 2 years
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
|
General disorders
Asthenia
|
22.0%
9/41 • Number of events 14 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 2 years
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
7.1%
3/42 • Number of events 3 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 2 years
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
4.7%
2/43 • Number of events 2 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 2 years
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
|
General disorders
Chest pain
|
7.3%
3/41 • Number of events 3 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 2 years
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
14.3%
6/42 • Number of events 6 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 2 years
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
7.0%
3/43 • Number of events 3 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 2 years
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
|
General disorders
Fatigue
|
17.1%
7/41 • Number of events 9 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 2 years
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
31.0%
13/42 • Number of events 16 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 2 years
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
16.3%
7/43 • Number of events 7 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 2 years
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
|
General disorders
Malaise
|
12.2%
5/41 • Number of events 6 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 2 years
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
7.1%
3/42 • Number of events 4 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 2 years
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
11.6%
5/43 • Number of events 6 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 2 years
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
|
General disorders
Non-cardiac chest pain
|
7.3%
3/41 • Number of events 3 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 2 years
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
2.4%
1/42 • Number of events 1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 2 years
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
0.00%
0/43 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 2 years
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
|
General disorders
Oedema peripheral
|
4.9%
2/41 • Number of events 2 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 2 years
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
2.4%
1/42 • Number of events 1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 2 years
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
2.3%
1/43 • Number of events 1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 2 years
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
|
General disorders
Pyrexia
|
19.5%
8/41 • Number of events 10 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 2 years
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
9.5%
4/42 • Number of events 6 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 2 years
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
11.6%
5/43 • Number of events 5 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 2 years
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
|
Infections and infestations
COVID-19
|
0.00%
0/41 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 2 years
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
4.8%
2/42 • Number of events 2 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 2 years
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
0.00%
0/43 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 2 years
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
|
Infections and infestations
Influenza
|
4.9%
2/41 • Number of events 3 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 2 years
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
0.00%
0/42 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 2 years
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
0.00%
0/43 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 2 years
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
|
Infections and infestations
Pneumonia
|
14.6%
6/41 • Number of events 7 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 2 years
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
14.3%
6/42 • Number of events 7 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 2 years
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
4.7%
2/43 • Number of events 2 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 2 years
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
|
Infections and infestations
Upper respiratory tract infection
|
7.3%
3/41 • Number of events 3 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 2 years
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
4.8%
2/42 • Number of events 2 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 2 years
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
9.3%
4/43 • Number of events 4 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 2 years
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
|
Injury, poisoning and procedural complications
Radiation oesophagitis
|
41.5%
17/41 • Number of events 17 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 2 years
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
38.1%
16/42 • Number of events 17 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 2 years
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
32.6%
14/43 • Number of events 14 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 2 years
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
|
Injury, poisoning and procedural complications
Radiation pneumonitis
|
4.9%
2/41 • Number of events 2 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 2 years
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
4.8%
2/42 • Number of events 2 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 2 years
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
2.3%
1/43 • Number of events 1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 2 years
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
|
Injury, poisoning and procedural complications
Radiation skin injury
|
4.9%
2/41 • Number of events 2 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 2 years
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
4.8%
2/42 • Number of events 2 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 2 years
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
7.0%
3/43 • Number of events 3 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 2 years
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
|
Injury, poisoning and procedural complications
Tracheal radiation injury
|
0.00%
0/41 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 2 years
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
7.1%
3/42 • Number of events 3 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 2 years
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
0.00%
0/43 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 2 years
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
|
Investigations
Alanine aminotransferase increased
|
19.5%
8/41 • Number of events 10 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 2 years
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
19.0%
8/42 • Number of events 10 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 2 years
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
18.6%
8/43 • Number of events 8 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 2 years
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
|
Investigations
Aspartate aminotransferase increased
|
22.0%
9/41 • Number of events 12 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 2 years
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
28.6%
12/42 • Number of events 12 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 2 years
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
11.6%
5/43 • Number of events 7 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 2 years
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
|
Investigations
Blood bilirubin increased
|
14.6%
6/41 • Number of events 7 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 2 years
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
4.8%
2/42 • Number of events 3 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 2 years
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
7.0%
3/43 • Number of events 6 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 2 years
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
|
Investigations
Blood creatine phosphokinase increased
|
4.9%
2/41 • Number of events 2 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 2 years
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
9.5%
4/42 • Number of events 4 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 2 years
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
2.3%
1/43 • Number of events 1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 2 years
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
|
Investigations
Blood creatinine increased
|
4.9%
2/41 • Number of events 6 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 2 years
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
14.3%
6/42 • Number of events 7 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 2 years
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
7.0%
3/43 • Number of events 4 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 2 years
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
|
Investigations
Blood fibrinogen increased
|
2.4%
1/41 • Number of events 1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 2 years
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
0.00%
0/42 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 2 years
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
4.7%
2/43 • Number of events 2 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 2 years
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
|
Investigations
Blood thyroid stimulating hormone decreased
|
0.00%
0/41 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 2 years
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
4.8%
2/42 • Number of events 2 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 2 years
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
2.3%
1/43 • Number of events 1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 2 years
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
|
Investigations
Blood urea increased
|
2.4%
1/41 • Number of events 1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 2 years
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
9.5%
4/42 • Number of events 8 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 2 years
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
2.3%
1/43 • Number of events 2 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 2 years
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
|
Investigations
C-reactive protein increased
|
2.4%
1/41 • Number of events 1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 2 years
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
7.1%
3/42 • Number of events 6 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 2 years
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
0.00%
0/43 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 2 years
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
|
Investigations
Fibrin D dimer increased
|
7.3%
3/41 • Number of events 3 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 2 years
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
0.00%
0/42 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 2 years
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
2.3%
1/43 • Number of events 1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 2 years
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
|
Investigations
Gamma-glutamyltransferase increased
|
7.3%
3/41 • Number of events 3 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 2 years
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
9.5%
4/42 • Number of events 5 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 2 years
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
4.7%
2/43 • Number of events 2 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 2 years
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
|
Investigations
Lymphocyte count decreased
|
26.8%
11/41 • Number of events 28 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 2 years
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
11.9%
5/42 • Number of events 9 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 2 years
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
20.9%
9/43 • Number of events 14 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 2 years
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
|
Investigations
Monocyte count decreased
|
0.00%
0/41 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 2 years
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
0.00%
0/42 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 2 years
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
4.7%
2/43 • Number of events 3 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 2 years
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
|
Investigations
Neutrophil count decreased
|
68.3%
28/41 • Number of events 88 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 2 years
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
73.8%
31/42 • Number of events 67 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 2 years
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
55.8%
24/43 • Number of events 81 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 2 years
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
|
Investigations
Platelet count decreased
|
63.4%
26/41 • Number of events 59 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 2 years
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
57.1%
24/42 • Number of events 47 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 2 years
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
51.2%
22/43 • Number of events 38 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 2 years
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
|
Investigations
Red blood cell count decreased
|
0.00%
0/41 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 2 years
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
4.8%
2/42 • Number of events 2 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 2 years
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
0.00%
0/43 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 2 years
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
|
Investigations
SARS-CoV-2 test positive
|
0.00%
0/41 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 2 years
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
7.1%
3/42 • Number of events 3 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 2 years
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
2.3%
1/43 • Number of events 1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 2 years
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
|
Investigations
Weight decreased
|
19.5%
8/41 • Number of events 11 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 2 years
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
35.7%
15/42 • Number of events 16 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 2 years
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
14.0%
6/43 • Number of events 6 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 2 years
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
|
Investigations
White blood cell count decreased
|
78.0%
32/41 • Number of events 116 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 2 years
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
73.8%
31/42 • Number of events 96 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 2 years
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
60.5%
26/43 • Number of events 87 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 2 years
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
51.2%
21/41 • Number of events 37 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 2 years
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
59.5%
25/42 • Number of events 45 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 2 years
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
41.9%
18/43 • Number of events 22 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 2 years
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
|
Metabolism and nutrition disorders
Hypercholesterolaemia
|
2.4%
1/41 • Number of events 3 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 2 years
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
14.3%
6/42 • Number of events 8 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 2 years
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
9.3%
4/43 • Number of events 6 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 2 years
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
14.6%
6/41 • Number of events 11 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 2 years
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
26.2%
11/42 • Number of events 19 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 2 years
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
9.3%
4/43 • Number of events 10 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 2 years
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
|
Metabolism and nutrition disorders
Hypertriglyceridaemia
|
9.8%
4/41 • Number of events 13 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 2 years
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
21.4%
9/42 • Number of events 22 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 2 years
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
14.0%
6/43 • Number of events 8 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 2 years
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
|
Metabolism and nutrition disorders
Hyperuricaemia
|
4.9%
2/41 • Number of events 5 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 2 years
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
7.1%
3/42 • Number of events 8 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 2 years
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
7.0%
3/43 • Number of events 5 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 2 years
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
29.3%
12/41 • Number of events 22 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 2 years
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
21.4%
9/42 • Number of events 17 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 2 years
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
9.3%
4/43 • Number of events 9 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 2 years
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
4.9%
2/41 • Number of events 2 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 2 years
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
4.8%
2/42 • Number of events 2 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 2 years
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
4.7%
2/43 • Number of events 6 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 2 years
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
|
Metabolism and nutrition disorders
Hypochloraemia
|
7.3%
3/41 • Number of events 3 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 2 years
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
14.3%
6/42 • Number of events 10 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 2 years
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
7.0%
3/43 • Number of events 4 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 2 years
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
22.0%
9/41 • Number of events 12 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 2 years
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
23.8%
10/42 • Number of events 17 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 2 years
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
9.3%
4/43 • Number of events 6 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 2 years
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
7.3%
3/41 • Number of events 3 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 2 years
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
2.4%
1/42 • Number of events 2 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 2 years
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
2.3%
1/43 • Number of events 1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 2 years
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
39.0%
16/41 • Number of events 28 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 2 years
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
50.0%
21/42 • Number of events 37 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 2 years
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
37.2%
16/43 • Number of events 24 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 2 years
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
|
Metabolism and nutrition disorders
Hypoproteinaemia
|
9.8%
4/41 • Number of events 5 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 2 years
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
11.9%
5/42 • Number of events 6 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 2 years
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
2.3%
1/43 • Number of events 1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 2 years
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
|
Metabolism and nutrition disorders
Malnutrition
|
4.9%
2/41 • Number of events 2 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 2 years
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
0.00%
0/42 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 2 years
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
2.3%
1/43 • Number of events 1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 2 years
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
12.2%
5/41 • Number of events 5 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 2 years
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
7.1%
3/42 • Number of events 4 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 2 years
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
2.3%
1/43 • Number of events 1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 2 years
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
4.9%
2/41 • Number of events 2 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 2 years
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
2.4%
1/42 • Number of events 1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 2 years
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
14.0%
6/43 • Number of events 8 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 2 years
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
0.00%
0/41 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 2 years
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
0.00%
0/42 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 2 years
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
4.7%
2/43 • Number of events 3 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 2 years
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
4.9%
2/41 • Number of events 2 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 2 years
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
2.4%
1/42 • Number of events 1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 2 years
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
0.00%
0/43 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 2 years
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
4.9%
2/41 • Number of events 2 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 2 years
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
9.5%
4/42 • Number of events 7 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 2 years
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
0.00%
0/43 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 2 years
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
|
Nervous system disorders
Dizziness
|
9.8%
4/41 • Number of events 4 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 2 years
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
16.7%
7/42 • Number of events 9 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 2 years
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
7.0%
3/43 • Number of events 4 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 2 years
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
|
Nervous system disorders
Headache
|
0.00%
0/41 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 2 years
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
11.9%
5/42 • Number of events 5 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 2 years
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
4.7%
2/43 • Number of events 2 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 2 years
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
|
Psychiatric disorders
Insomnia
|
12.2%
5/41 • Number of events 5 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 2 years
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
11.9%
5/42 • Number of events 7 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 2 years
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
9.3%
4/43 • Number of events 4 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 2 years
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
29.3%
12/41 • Number of events 16 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 2 years
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
26.2%
11/42 • Number of events 12 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 2 years
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
27.9%
12/43 • Number of events 12 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 2 years
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
4.9%
2/41 • Number of events 3 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 2 years
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
11.9%
5/42 • Number of events 5 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 2 years
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
4.7%
2/43 • Number of events 2 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 2 years
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
12.2%
5/41 • Number of events 7 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 2 years
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
7.1%
3/42 • Number of events 3 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 2 years
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
4.7%
2/43 • Number of events 2 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 2 years
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
4.9%
2/41 • Number of events 2 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 2 years
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
2.4%
1/42 • Number of events 1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 2 years
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
2.3%
1/43 • Number of events 1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 2 years
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
|
Respiratory, thoracic and mediastinal disorders
Laryngeal pain
|
4.9%
2/41 • Number of events 2 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 2 years
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
4.8%
2/42 • Number of events 2 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 2 years
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
4.7%
2/43 • Number of events 2 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 2 years
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
2.4%
1/41 • Number of events 1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 2 years
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
7.1%
3/42 • Number of events 3 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 2 years
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
4.7%
2/43 • Number of events 2 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 2 years
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
9.8%
4/41 • Number of events 4 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 2 years
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
9.5%
4/42 • Number of events 5 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 2 years
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
0.00%
0/43 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 2 years
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
17.1%
7/41 • Number of events 10 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 2 years
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
11.9%
5/42 • Number of events 5 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 2 years
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
4.7%
2/43 • Number of events 2 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 2 years
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
70.7%
29/41 • Number of events 32 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 2 years
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
78.6%
33/42 • Number of events 40 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 2 years
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
76.7%
33/43 • Number of events 35 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 2 years
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
|
Skin and subcutaneous tissue disorders
Eczema
|
12.2%
5/41 • Number of events 7 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 2 years
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
2.4%
1/42 • Number of events 3 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 2 years
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
0.00%
0/43 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 2 years
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
7.3%
3/41 • Number of events 3 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 2 years
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
2.4%
1/42 • Number of events 1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 2 years
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
2.3%
1/43 • Number of events 1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 2 years
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
|
Skin and subcutaneous tissue disorders
Rash
|
39.0%
16/41 • Number of events 17 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 2 years
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
4.8%
2/42 • Number of events 4 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 2 years
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
0.00%
0/43 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 2 years
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
|
Vascular disorders
Hypertension
|
2.4%
1/41 • Number of events 1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 2 years
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
11.9%
5/42 • Number of events 7 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 2 years
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
9.3%
4/43 • Number of events 8 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 2 years
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
|
Vascular disorders
Hypotension
|
2.4%
1/41 • Number of events 1 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 2 years
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
9.5%
4/42 • Number of events 6 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 2 years
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
0.00%
0/43 • All-cause mortality and adverse events (AEs): From the first dose of study drug(s) to 30 days after the last dose; up to approximately 2 years
All-cause mortality is reported for all randomized participants. Serious and other adverse events include all randomized participants who received ≥ 1 dose of any study treatment AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
Additional Information
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