Trial Outcomes & Findings for Study of Platinum Plus Etoposide With or Without Tislelizumab in Participants With Untreated Extensive-Stage Small Cell Lung Cancer (NCT NCT04005716)
NCT ID: NCT04005716
Last Updated: 2025-02-28
Results Overview
Defined as the time from the date of randomization to the date of death due to any cause. Median OS was estimated using Kaplan-Meier methodology.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
457 participants
Primary outcome timeframe
From randomization to the primary completion cut-off on April 19, 2023, the median follow-up was 15.44 months (range: 0.2-44.9) for Arm A and 13.22 months (range: 0.1-40.8) for Arm B.
Results posted on
2025-02-28
Participant Flow
Participants were enrolled across multiple study centers in China. The first participant was randomized on July 22, 2019, and the last participant completed the study on December 29, 2023.
Participants were randomized in a 1:1 ratio to receive chemotherapy (cisplatin or carboplatin + etoposide) in combination with tislelizumab (Arm A) or placebo (Arm B).
Participant milestones
| Measure |
Arm A: Tislelizumab + Chemotherapy
Participants received tislelizumab with cisplatin or carboplatin and etoposide every 3 weeks for 4 cycles, then transitioned to maintenance tislelizumab every 3 weeks. Tislelizumab (200 mg) was administered on Day 1 of each cycle. Cisplatin (75 mg/m²) or carboplatin (AUC 5 mg/mL/min) was given on Day 1, and etoposide (100 mg/m²) on Days 1 to 3, with all chemotherapy discontinued after Cycle 4.
|
Arm B: Placebo + Chemotherapy
Participants received a placebo (matching the tislelizumab dose) with cisplatin or carboplatin and etoposide every 3 weeks for 4 cycles, then transitioned to maintenance placebo every 3 weeks. Cisplatin (75 mg/m²) or carboplatin (AUC 5 mg/mL/min) was given on Day 1, and etoposide (100 mg/m²) on Days 1 to 3, with all chemotherapy discontinued after Cycle 4.
|
|---|---|---|
|
Overall Study
STARTED
|
227
|
230
|
|
Overall Study
Treated
|
227
|
229
|
|
Overall Study
COMPLETED
|
49
|
26
|
|
Overall Study
NOT COMPLETED
|
178
|
204
|
Reasons for withdrawal
| Measure |
Arm A: Tislelizumab + Chemotherapy
Participants received tislelizumab with cisplatin or carboplatin and etoposide every 3 weeks for 4 cycles, then transitioned to maintenance tislelizumab every 3 weeks. Tislelizumab (200 mg) was administered on Day 1 of each cycle. Cisplatin (75 mg/m²) or carboplatin (AUC 5 mg/mL/min) was given on Day 1, and etoposide (100 mg/m²) on Days 1 to 3, with all chemotherapy discontinued after Cycle 4.
|
Arm B: Placebo + Chemotherapy
Participants received a placebo (matching the tislelizumab dose) with cisplatin or carboplatin and etoposide every 3 weeks for 4 cycles, then transitioned to maintenance placebo every 3 weeks. Cisplatin (75 mg/m²) or carboplatin (AUC 5 mg/mL/min) was given on Day 1, and etoposide (100 mg/m²) on Days 1 to 3, with all chemotherapy discontinued after Cycle 4.
|
|---|---|---|
|
Overall Study
Death
|
175
|
196
|
|
Overall Study
Withdrawal by Subject
|
1
|
6
|
|
Overall Study
Lost to Follow-up
|
2
|
2
|
Baseline Characteristics
Study of Platinum Plus Etoposide With or Without Tislelizumab in Participants With Untreated Extensive-Stage Small Cell Lung Cancer
Baseline characteristics by cohort
| Measure |
Arm A: Tislelizumab + Chemotherapy
n=227 Participants
Participants received tislelizumab with cisplatin or carboplatin and etoposide every 3 weeks for 4 cycles, then transitioned to maintenance tislelizumab every 3 weeks. Tislelizumab (200 mg) was administered on Day 1 of each cycle. Cisplatin (75 mg/m²) or carboplatin (AUC 5 mg/mL/min) was given on Day 1, and etoposide (100 mg/m²) on Days 1 to 3, with all chemotherapy discontinued after Cycle 4.
|
Arm B: Placebo + Chemotherapy
n=230 Participants
Participants received a placebo (matching the tislelizumab dose) with cisplatin or carboplatin and etoposide every 3 weeks for 4 cycles, then transitioned to maintenance placebo every 3 weeks. Cisplatin (75 mg/m²) or carboplatin (AUC 5 mg/mL/min) was given on Day 1, and etoposide (100 mg/m²) on Days 1 to 3, with all chemotherapy discontinued after Cycle 4.
|
Total
n=457 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
61.5 years
STANDARD_DEVIATION 7.75 • n=5 Participants
|
60.7 years
STANDARD_DEVIATION 8.25 • n=7 Participants
|
61.1 years
STANDARD_DEVIATION 8.01 • n=5 Participants
|
|
Sex: Female, Male
Female
|
41 Participants
n=5 Participants
|
44 Participants
n=7 Participants
|
85 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
186 Participants
n=5 Participants
|
186 Participants
n=7 Participants
|
372 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
227 Participants
n=5 Participants
|
230 Participants
n=7 Participants
|
457 Participants
n=5 Participants
|
|
Eastern Cooperative Oncology Group Performance Status
0
|
35 Participants
n=5 Participants
|
34 Participants
n=7 Participants
|
69 Participants
n=5 Participants
|
|
Eastern Cooperative Oncology Group Performance Status
1
|
192 Participants
n=5 Participants
|
196 Participants
n=7 Participants
|
388 Participants
n=5 Participants
|
|
Brain Metastases
Yes
|
1 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Brain Metastases
No
|
226 Participants
n=5 Participants
|
226 Participants
n=7 Participants
|
452 Participants
n=5 Participants
|
|
Chemotherapy
Cisplatin
|
47 Participants
n=5 Participants
|
49 Participants
n=7 Participants
|
96 Participants
n=5 Participants
|
|
Chemotherapy
Carboplatin
|
180 Participants
n=5 Participants
|
181 Participants
n=7 Participants
|
361 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: From randomization to the primary completion cut-off on April 19, 2023, the median follow-up was 15.44 months (range: 0.2-44.9) for Arm A and 13.22 months (range: 0.1-40.8) for Arm B.Population: Intent to treat analysis set
Defined as the time from the date of randomization to the date of death due to any cause. Median OS was estimated using Kaplan-Meier methodology.
Outcome measures
| Measure |
Arm A: Tislelizumab + Chemotherapy
n=227 Participants
Participants received tislelizumab with cisplatin or carboplatin and etoposide every 3 weeks for 4 cycles, then transitioned to maintenance tislelizumab every 3 weeks. Tislelizumab (200 mg) was administered on Day 1 of each cycle. Cisplatin (75 mg/m²) or carboplatin (AUC 5 mg/mL/min) was given on Day 1, and etoposide (100 mg/m²) on Days 1 to 3, with all chemotherapy discontinued after Cycle 4.
|
Arm B: Placebo + Chemotherapy
n=230 Participants
Participants received a placebo (matching the tislelizumab dose) with cisplatin or carboplatin and etoposide every 3 weeks for 4 cycles, then transitioned to maintenance placebo every 3 weeks. Cisplatin (75 mg/m²) or carboplatin (AUC 5 mg/mL/min) was given on Day 1, and etoposide (100 mg/m²) on Days 1 to 3, with all chemotherapy discontinued after Cycle 4.
|
|---|---|---|
|
Overall Survival (OS)
|
15.5 Months
Interval 13.5 to 17.1
|
13.5 Months
Interval 12.1 to 14.9
|
SECONDARY outcome
Timeframe: From randomization to the primary completion cut-off on April 19, 2023, the median follow-up was 15.44 months (range: 0.2-44.9) for Arm A and 13.22 months (range: 0.1-40.8) for Arm B.Population: Intent to treat analysis set
Defined as the time from randomization to the first objectively documented disease progression, or death from any cause, whichever occurred first, as assessed by the investigator per the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. Kaplan-Meier methodology was used to estimate the median PFS. Progressive Disease (PD): At least a 20% increase in the size of target lesions, with an absolute increase of at least 5 mm, or unequivocal progression of existing non-target lesions, or any new lesions.
Outcome measures
| Measure |
Arm A: Tislelizumab + Chemotherapy
n=227 Participants
Participants received tislelizumab with cisplatin or carboplatin and etoposide every 3 weeks for 4 cycles, then transitioned to maintenance tislelizumab every 3 weeks. Tislelizumab (200 mg) was administered on Day 1 of each cycle. Cisplatin (75 mg/m²) or carboplatin (AUC 5 mg/mL/min) was given on Day 1, and etoposide (100 mg/m²) on Days 1 to 3, with all chemotherapy discontinued after Cycle 4.
|
Arm B: Placebo + Chemotherapy
n=230 Participants
Participants received a placebo (matching the tislelizumab dose) with cisplatin or carboplatin and etoposide every 3 weeks for 4 cycles, then transitioned to maintenance placebo every 3 weeks. Cisplatin (75 mg/m²) or carboplatin (AUC 5 mg/mL/min) was given on Day 1, and etoposide (100 mg/m²) on Days 1 to 3, with all chemotherapy discontinued after Cycle 4.
|
|---|---|---|
|
Progression Free Survival (PFS)
|
4.7 Months
Interval 4.3 to 5.5
|
4.3 Months
Interval 4.2 to 4.4
|
SECONDARY outcome
Timeframe: From randomization to the primary completion cut-off on April 19, 2023, the median follow-up was 15.44 months (range: 0.2-44.9) for Arm A and 13.22 months (range: 0.1-40.8) for Arm B.Population: Intent to treat analysis set
Orr is defined as the percentage of participants who had partial response or complete response as determined by the investigator per RECIST v1.1 in all randomized patients with measurable disease at baseline. Complete Response (CR): Disappearance of all target and non-target lesions and no new lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \< 10 mm. Partial Response (PR): At least a 30% decrease in the sum of diameters of target lesions with no progression of non-target lesions and no new lesions, or disappearance of all target lesions with persistence of one or more non-target lesion(s) and/or maintenance of tumor marker level above the normal limits and no new lesions.
Outcome measures
| Measure |
Arm A: Tislelizumab + Chemotherapy
n=227 Participants
Participants received tislelizumab with cisplatin or carboplatin and etoposide every 3 weeks for 4 cycles, then transitioned to maintenance tislelizumab every 3 weeks. Tislelizumab (200 mg) was administered on Day 1 of each cycle. Cisplatin (75 mg/m²) or carboplatin (AUC 5 mg/mL/min) was given on Day 1, and etoposide (100 mg/m²) on Days 1 to 3, with all chemotherapy discontinued after Cycle 4.
|
Arm B: Placebo + Chemotherapy
n=230 Participants
Participants received a placebo (matching the tislelizumab dose) with cisplatin or carboplatin and etoposide every 3 weeks for 4 cycles, then transitioned to maintenance placebo every 3 weeks. Cisplatin (75 mg/m²) or carboplatin (AUC 5 mg/mL/min) was given on Day 1, and etoposide (100 mg/m²) on Days 1 to 3, with all chemotherapy discontinued after Cycle 4.
|
|---|---|---|
|
Overall Response Rate (ORR)
|
68.3 percentage of participants
Interval 61.8 to 74.3
|
61.7 percentage of participants
Interval 55.1 to 68.0
|
SECONDARY outcome
Timeframe: From randomization to the primary completion cut-off on April 19, 2023, the median follow-up was 15.44 months (range: 0.2-44.9) for Arm A and 13.22 months (range: 0.1-40.8) for Arm B.Population: Intent to treat analysis set
Defined as the percentage of participants whose best overall response (BOR) is complete response, partial response, or stable disease per RECIST v1.1. Stable Disease: Neither sufficient shrinkage of target lesions to qualify for PR nor sufficient increase to qualify for progressive disease, persistence of one or more non-target lesion(s) and/or maintenance of tumor marker level above the normal limits, and no new lesions.
Outcome measures
| Measure |
Arm A: Tislelizumab + Chemotherapy
n=227 Participants
Participants received tislelizumab with cisplatin or carboplatin and etoposide every 3 weeks for 4 cycles, then transitioned to maintenance tislelizumab every 3 weeks. Tislelizumab (200 mg) was administered on Day 1 of each cycle. Cisplatin (75 mg/m²) or carboplatin (AUC 5 mg/mL/min) was given on Day 1, and etoposide (100 mg/m²) on Days 1 to 3, with all chemotherapy discontinued after Cycle 4.
|
Arm B: Placebo + Chemotherapy
n=230 Participants
Participants received a placebo (matching the tislelizumab dose) with cisplatin or carboplatin and etoposide every 3 weeks for 4 cycles, then transitioned to maintenance placebo every 3 weeks. Cisplatin (75 mg/m²) or carboplatin (AUC 5 mg/mL/min) was given on Day 1, and etoposide (100 mg/m²) on Days 1 to 3, with all chemotherapy discontinued after Cycle 4.
|
|---|---|---|
|
Disease Control Rate (DCR)
|
88.5 percentage of participants
Interval 83.7 to 92.4
|
88.3 percentage of participants
Interval 83.4 to 92.1
|
SECONDARY outcome
Timeframe: From randomization to the primary completion cut-off on April 19, 2023, the median follow-up was 15.44 months (range: 0.2-44.9) for Arm A and 13.22 months (range: 0.1-40.8) for Arm B.Population: Intent to treat analysis set
Defined as the percentage of participants whose best overall response (BOR) is complete response, partial response, or durable stable disease (stable disease for at least 24 weeks) per RECIST v1.1.
Outcome measures
| Measure |
Arm A: Tislelizumab + Chemotherapy
n=227 Participants
Participants received tislelizumab with cisplatin or carboplatin and etoposide every 3 weeks for 4 cycles, then transitioned to maintenance tislelizumab every 3 weeks. Tislelizumab (200 mg) was administered on Day 1 of each cycle. Cisplatin (75 mg/m²) or carboplatin (AUC 5 mg/mL/min) was given on Day 1, and etoposide (100 mg/m²) on Days 1 to 3, with all chemotherapy discontinued after Cycle 4.
|
Arm B: Placebo + Chemotherapy
n=230 Participants
Participants received a placebo (matching the tislelizumab dose) with cisplatin or carboplatin and etoposide every 3 weeks for 4 cycles, then transitioned to maintenance placebo every 3 weeks. Cisplatin (75 mg/m²) or carboplatin (AUC 5 mg/mL/min) was given on Day 1, and etoposide (100 mg/m²) on Days 1 to 3, with all chemotherapy discontinued after Cycle 4.
|
|---|---|---|
|
Clinical Benefit Rate (CBR)
|
69.2 percentage of participants
Interval 62.7 to 75.1
|
65.2 percentage of participants
Interval 58.7 to 71.4
|
SECONDARY outcome
Timeframe: From randomization to the primary completion cut-off on April 19, 2023, the median follow-up was 15.44 months (range: 0.2-44.9) for Arm A and 13.22 months (range: 0.1-40.8) for Arm B.Population: Intent to treat analysis Set. Only participants with best overall response of complete response or partial response confirmed per RECIST v1.1 were included in the analysis, and percentages were based on the number of responders
Defined as the time from the first occurrence of a documented objective response to the time of relapse, as determined by the investigator per RECIST v1.1, or death from any cause, whichever comes first. Median DOR was estimated using Kaplan-Meier methodology.
Outcome measures
| Measure |
Arm A: Tislelizumab + Chemotherapy
n=155 Participants
Participants received tislelizumab with cisplatin or carboplatin and etoposide every 3 weeks for 4 cycles, then transitioned to maintenance tislelizumab every 3 weeks. Tislelizumab (200 mg) was administered on Day 1 of each cycle. Cisplatin (75 mg/m²) or carboplatin (AUC 5 mg/mL/min) was given on Day 1, and etoposide (100 mg/m²) on Days 1 to 3, with all chemotherapy discontinued after Cycle 4.
|
Arm B: Placebo + Chemotherapy
n=142 Participants
Participants received a placebo (matching the tislelizumab dose) with cisplatin or carboplatin and etoposide every 3 weeks for 4 cycles, then transitioned to maintenance placebo every 3 weeks. Cisplatin (75 mg/m²) or carboplatin (AUC 5 mg/mL/min) was given on Day 1, and etoposide (100 mg/m²) on Days 1 to 3, with all chemotherapy discontinued after Cycle 4.
|
|---|---|---|
|
Duration of Response (DOR)
|
4.3 Months
Interval 4.1 to 5.6
|
3.7 Months
Interval 3.0 to 4.1
|
SECONDARY outcome
Timeframe: From the first dose to 30 days after the last dose or final cutoff on December 29, 2023, maximum treatment exposure was 232 weeks for Arm A and 157 weeks for Arm B.Population: The Safety Analysis Set includes all participants randomized and received any dose of any 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) version 5.0.
Outcome measures
| Measure |
Arm A: Tislelizumab + Chemotherapy
n=227 Participants
Participants received tislelizumab with cisplatin or carboplatin and etoposide every 3 weeks for 4 cycles, then transitioned to maintenance tislelizumab every 3 weeks. Tislelizumab (200 mg) was administered on Day 1 of each cycle. Cisplatin (75 mg/m²) or carboplatin (AUC 5 mg/mL/min) was given on Day 1, and etoposide (100 mg/m²) on Days 1 to 3, with all chemotherapy discontinued after Cycle 4.
|
Arm B: Placebo + Chemotherapy
n=229 Participants
Participants received a placebo (matching the tislelizumab dose) with cisplatin or carboplatin and etoposide every 3 weeks for 4 cycles, then transitioned to maintenance placebo every 3 weeks. Cisplatin (75 mg/m²) or carboplatin (AUC 5 mg/mL/min) was given on Day 1, and etoposide (100 mg/m²) on Days 1 to 3, with all chemotherapy discontinued after Cycle 4.
|
|---|---|---|
|
Number of Participants With Adverse Events
SAEs
|
94 Participants
|
70 Participants
|
|
Number of Participants With Adverse Events
TEAEs
|
226 Participants
|
228 Participants
|
SECONDARY outcome
Timeframe: Baseline to Cycles 4 and 6 ( Each cycle was 21 days)Population: The HRQoL analysis set included all randomized participants who received any dose of study drug and completed at least one HRQoL assessment. Only participants with data at both baseline and corresponding post-baseline visit are included in the analysis at each time point.
The EORTC QLQ-30 contains 30 questions that incorporate 5 functional scales (physical functioning, role functioning, emotional functioning, cognitive functioning, and social functioning), 1 global health status scale, 3 symptom scales (fatigue, nausea and vomiting, and pain), and 6 single items (dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties). The participant answers questions about their health during the past week. There are 28 questions answered on a 4-point scale where 1 = Not at all (best) and 4 = Very Much (worst) and 2 global health quality of life (QOL) questions answered on a 7-point scale where 1 = Very poor and 7 = Excellent. Raw scores are transformed into a 0 to 100 scale via linear transformation. Higher scores in GHS and functional scales indicate better quality of life.
Outcome measures
| Measure |
Arm A: Tislelizumab + Chemotherapy
n=225 Participants
Participants received tislelizumab with cisplatin or carboplatin and etoposide every 3 weeks for 4 cycles, then transitioned to maintenance tislelizumab every 3 weeks. Tislelizumab (200 mg) was administered on Day 1 of each cycle. Cisplatin (75 mg/m²) or carboplatin (AUC 5 mg/mL/min) was given on Day 1, and etoposide (100 mg/m²) on Days 1 to 3, with all chemotherapy discontinued after Cycle 4.
|
Arm B: Placebo + Chemotherapy
n=229 Participants
Participants received a placebo (matching the tislelizumab dose) with cisplatin or carboplatin and etoposide every 3 weeks for 4 cycles, then transitioned to maintenance placebo every 3 weeks. Cisplatin (75 mg/m²) or carboplatin (AUC 5 mg/mL/min) was given on Day 1, and etoposide (100 mg/m²) on Days 1 to 3, with all chemotherapy discontinued after Cycle 4.
|
|---|---|---|
|
Change From Baseline in the European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) Global Health Status and Physical Function Score.
Global Health Status/Quality of Life (Cycle 4)
|
8.9 Score on a scale
Standard Deviation 22.79
|
4.5 Score on a scale
Standard Deviation 19.46
|
|
Change From Baseline in the European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) Global Health Status and Physical Function Score.
Global Health Status/Quality of Life (Cycle 6)
|
11.3 Score on a scale
Standard Deviation 21.30
|
4.2 Score on a scale
Standard Deviation 19.04
|
|
Change From Baseline in the European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) Global Health Status and Physical Function Score.
Physical Functioning (Cycle 4)
|
0.6 Score on a scale
Standard Deviation 14.82
|
0.4 Score on a scale
Standard Deviation 14.57
|
|
Change From Baseline in the European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) Global Health Status and Physical Function Score.
Physical Functioning (Cycle 6)
|
1.9 Score on a scale
Standard Deviation 15.18
|
1.8 Score on a scale
Standard Deviation 12.36
|
SECONDARY outcome
Timeframe: Baseline to Cycles 4 and 6 ( Each cycle was 21 days)Population: HRQoL analysis set. Only participants with data at both baseline and corresponding post-baseline visit are included in the analysis at each time point.
Change from baseline in EORTC QLQ-CL13 scores for coughing, dysphagia, and chest pain. The EORTC QLQ-LC13 is a questionnaire that measures lung cancer-specific disease and treatment symptoms. It includes questions about specific symptoms in which participants respond based on a 4-point scale, where 1 is "not at all" and 4 is "very much". Raw scores are transformed into a 0 to 100 scale via linear transformation. A lower score indicates an improvement in symptoms.
Outcome measures
| Measure |
Arm A: Tislelizumab + Chemotherapy
n=225 Participants
Participants received tislelizumab with cisplatin or carboplatin and etoposide every 3 weeks for 4 cycles, then transitioned to maintenance tislelizumab every 3 weeks. Tislelizumab (200 mg) was administered on Day 1 of each cycle. Cisplatin (75 mg/m²) or carboplatin (AUC 5 mg/mL/min) was given on Day 1, and etoposide (100 mg/m²) on Days 1 to 3, with all chemotherapy discontinued after Cycle 4.
|
Arm B: Placebo + Chemotherapy
n=229 Participants
Participants received a placebo (matching the tislelizumab dose) with cisplatin or carboplatin and etoposide every 3 weeks for 4 cycles, then transitioned to maintenance placebo every 3 weeks. Cisplatin (75 mg/m²) or carboplatin (AUC 5 mg/mL/min) was given on Day 1, and etoposide (100 mg/m²) on Days 1 to 3, with all chemotherapy discontinued after Cycle 4.
|
|---|---|---|
|
Change From Baseline in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire-Lung Cancer (EORTC QLQ-LC13) Symptom Scores
Coughing (Cycle 4)
|
-19.5 score on a scale
Standard Deviation 26.58
|
-16.0 score on a scale
Standard Deviation 22.85
|
|
Change From Baseline in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire-Lung Cancer (EORTC QLQ-LC13) Symptom Scores
Coughing (Cycle 6)
|
-18.6 score on a scale
Standard Deviation 27.86
|
-16.7 score on a scale
Standard Deviation 25.08
|
|
Change From Baseline in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire-Lung Cancer (EORTC QLQ-LC13) Symptom Scores
Dysphagia (Cycle 4)
|
-2.5 score on a scale
Standard Deviation 12.12
|
-3.1 score on a scale
Standard Deviation 14.72
|
|
Change From Baseline in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire-Lung Cancer (EORTC QLQ-LC13) Symptom Scores
Dysphagia (Cycle 6)
|
-2.9 score on a scale
Standard Deviation 11.47
|
-3.5 score on a scale
Standard Deviation 15.23
|
|
Change From Baseline in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire-Lung Cancer (EORTC QLQ-LC13) Symptom Scores
Chest Pain (Cycle 4)
|
-7.5 score on a scale
Standard Deviation 22.65
|
-5.9 score on a scale
Standard Deviation 20.97
|
|
Change From Baseline in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire-Lung Cancer (EORTC QLQ-LC13) Symptom Scores
Chest Pain (Cycle 6)
|
-7.0 score on a scale
Standard Deviation 25.34
|
-6.9 score on a scale
Standard Deviation 21.51
|
SECONDARY outcome
Timeframe: From randomization to the primary completion data cut-off on April 19, 2023, the median follow-up was 15.44 months (range: 0.2-44.9) for Arm A and 13.22 months (range: 0.1-40.8) for Arm B.Population: HRQoL analysis set
Time to deterioration is defined as the time from randomization to the first confirmed worsening score or death. Clinically meaningful deterioration is defined as a ≥10-point decrease from baseline in QLQ-C30 physical functioning and a ≥10-point increase in QLQ-LC13 coughing and chest pain scores. If a participant did not have an event (death or deterioration), they were censored at their last clinic visit at which corresponding score was measured. Median TTD was estimated using Kaplan-Meier methodology.
Outcome measures
| Measure |
Arm A: Tislelizumab + Chemotherapy
n=227 Participants
Participants received tislelizumab with cisplatin or carboplatin and etoposide every 3 weeks for 4 cycles, then transitioned to maintenance tislelizumab every 3 weeks. Tislelizumab (200 mg) was administered on Day 1 of each cycle. Cisplatin (75 mg/m²) or carboplatin (AUC 5 mg/mL/min) was given on Day 1, and etoposide (100 mg/m²) on Days 1 to 3, with all chemotherapy discontinued after Cycle 4.
|
Arm B: Placebo + Chemotherapy
n=229 Participants
Participants received a placebo (matching the tislelizumab dose) with cisplatin or carboplatin and etoposide every 3 weeks for 4 cycles, then transitioned to maintenance placebo every 3 weeks. Cisplatin (75 mg/m²) or carboplatin (AUC 5 mg/mL/min) was given on Day 1, and etoposide (100 mg/m²) on Days 1 to 3, with all chemotherapy discontinued after Cycle 4.
|
|---|---|---|
|
Time to Deterioration (TTD)
QLQ-C30: Physical Functioning
|
NA Months
Interval 20.5 to
Could not be estimated due to insufficient number of participants with events
|
NA Months
Interval 10.3 to
Could not be estimated due to insufficient number of participants with events
|
|
Time to Deterioration (TTD)
QLQ-LC13: Coughing
|
NA Months
Could not be estimated due to insufficient number of participants with events
|
NA Months
Could not be estimated due to insufficient number of participants with events
|
|
Time to Deterioration (TTD)
QLQ-LC13: Chest Pain
|
NA Months
Could not be estimated due to insufficient number of participants with events
|
NA Months
Could not be estimated due to insufficient number of participants with events
|
Adverse Events
Arm A: Tislelizumab + Chemotherapy
Serious events: 94 serious events
Other events: 226 other events
Deaths: 175 deaths
Arm B: Placebo + Chemotherapy
Serious events: 70 serious events
Other events: 228 other events
Deaths: 196 deaths
Serious adverse events
| Measure |
Arm A: Tislelizumab + Chemotherapy
n=227 participants at risk
Participants received tislelizumab with cisplatin or carboplatin and etoposide every 3 weeks for 4 cycles, then transitioned to maintenance tislelizumab every 3 weeks. Tislelizumab (200 mg) was administered on Day 1 of each cycle. Cisplatin (75 mg/m²) or carboplatin (AUC 5 mg/mL/min) was given on Day 1, and etoposide (100 mg/m²) on Days 1 to 3, with all chemotherapy discontinued after Cycle 4.
|
Arm B: Placebo + Chemotherapy
n=229 participants at risk
Participants received a placebo (matching the tislelizumab dose) with cisplatin or carboplatin and etoposide every 3 weeks for 4 cycles, then transitioned to maintenance placebo every 3 weeks. Cisplatin (75 mg/m²) or carboplatin (AUC 5 mg/mL/min) was given on Day 1, and etoposide (100 mg/m²) on Days 1 to 3, with all chemotherapy discontinued after Cycle 4.
|
|---|---|---|
|
Endocrine disorders
Hypothyroidism
|
0.88%
2/227 • Number of events 2 • All-cause mortality is reported from randomization to the end of study (up to 53 months). Adverse events are reported from from the first dose to 30 days after the last dose or final cutoff on December 29, 2023, maximum treatment exposure was 232 weeks for Arm A and 157 weeks for Arm B.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
0.00%
0/229 • All-cause mortality is reported from randomization to the end of study (up to 53 months). Adverse events are reported from from the first dose to 30 days after the last dose or final cutoff on December 29, 2023, maximum treatment exposure was 232 weeks for Arm A and 157 weeks for Arm B.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
|
Blood and lymphatic system disorders
Anaemia
|
1.3%
3/227 • Number of events 3 • All-cause mortality is reported from randomization to the end of study (up to 53 months). Adverse events are reported from from the first dose to 30 days after the last dose or final cutoff on December 29, 2023, maximum treatment exposure was 232 weeks for Arm A and 157 weeks for Arm B.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
1.7%
4/229 • Number of events 4 • All-cause mortality is reported from randomization to the end of study (up to 53 months). Adverse events are reported from from the first dose to 30 days after the last dose or final cutoff on December 29, 2023, maximum treatment exposure was 232 weeks for Arm A and 157 weeks for Arm B.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
1.3%
3/227 • Number of events 3 • All-cause mortality is reported from randomization to the end of study (up to 53 months). Adverse events are reported from from the first dose to 30 days after the last dose or final cutoff on December 29, 2023, maximum treatment exposure was 232 weeks for Arm A and 157 weeks for Arm B.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
2.2%
5/229 • Number of events 5 • All-cause mortality is reported from randomization to the end of study (up to 53 months). Adverse events are reported from from the first dose to 30 days after the last dose or final cutoff on December 29, 2023, maximum treatment exposure was 232 weeks for Arm A and 157 weeks for Arm B.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
|
Blood and lymphatic system disorders
Leukopenia
|
1.3%
3/227 • Number of events 3 • All-cause mortality is reported from randomization to the end of study (up to 53 months). Adverse events are reported from from the first dose to 30 days after the last dose or final cutoff on December 29, 2023, maximum treatment exposure was 232 weeks for Arm A and 157 weeks for Arm B.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
0.44%
1/229 • Number of events 1 • All-cause mortality is reported from randomization to the end of study (up to 53 months). Adverse events are reported from from the first dose to 30 days after the last dose or final cutoff on December 29, 2023, maximum treatment exposure was 232 weeks for Arm A and 157 weeks for Arm B.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
|
Blood and lymphatic system disorders
Neutropenia
|
7.0%
16/227 • Number of events 18 • All-cause mortality is reported from randomization to the end of study (up to 53 months). Adverse events are reported from from the first dose to 30 days after the last dose or final cutoff on December 29, 2023, maximum treatment exposure was 232 weeks for Arm A and 157 weeks for Arm B.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
3.9%
9/229 • Number of events 9 • All-cause mortality is reported from randomization to the end of study (up to 53 months). Adverse events are reported from from the first dose to 30 days after the last dose or final cutoff on December 29, 2023, maximum treatment exposure was 232 weeks for Arm A and 157 weeks for Arm B.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
7.5%
17/227 • Number of events 20 • All-cause mortality is reported from randomization to the end of study (up to 53 months). Adverse events are reported from from the first dose to 30 days after the last dose or final cutoff on December 29, 2023, maximum treatment exposure was 232 weeks for Arm A and 157 weeks for Arm B.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
7.9%
18/229 • Number of events 20 • All-cause mortality is reported from randomization to the end of study (up to 53 months). Adverse events are reported from from the first dose to 30 days after the last dose or final cutoff on December 29, 2023, maximum treatment exposure was 232 weeks for Arm A and 157 weeks for Arm B.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
|
Cardiac disorders
Acute coronary syndrome
|
0.00%
0/227 • All-cause mortality is reported from randomization to the end of study (up to 53 months). Adverse events are reported from from the first dose to 30 days after the last dose or final cutoff on December 29, 2023, maximum treatment exposure was 232 weeks for Arm A and 157 weeks for Arm B.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
0.44%
1/229 • Number of events 1 • All-cause mortality is reported from randomization to the end of study (up to 53 months). Adverse events are reported from from the first dose to 30 days after the last dose or final cutoff on December 29, 2023, maximum treatment exposure was 232 weeks for Arm A and 157 weeks for Arm B.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
|
Cardiac disorders
Autoimmune myocarditis
|
0.44%
1/227 • Number of events 1 • All-cause mortality is reported from randomization to the end of study (up to 53 months). Adverse events are reported from from the first dose to 30 days after the last dose or final cutoff on December 29, 2023, maximum treatment exposure was 232 weeks for Arm A and 157 weeks for Arm B.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
0.00%
0/229 • All-cause mortality is reported from randomization to the end of study (up to 53 months). Adverse events are reported from from the first dose to 30 days after the last dose or final cutoff on December 29, 2023, maximum treatment exposure was 232 weeks for Arm A and 157 weeks for Arm B.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
|
Cardiac disorders
Cardiac failure
|
0.44%
1/227 • Number of events 1 • All-cause mortality is reported from randomization to the end of study (up to 53 months). Adverse events are reported from from the first dose to 30 days after the last dose or final cutoff on December 29, 2023, maximum treatment exposure was 232 weeks for Arm A and 157 weeks for Arm B.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
0.44%
1/229 • Number of events 1 • All-cause mortality is reported from randomization to the end of study (up to 53 months). Adverse events are reported from from the first dose to 30 days after the last dose or final cutoff on December 29, 2023, maximum treatment exposure was 232 weeks for Arm A and 157 weeks for Arm B.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
|
Cardiac disorders
Cardiac failure acute
|
0.44%
1/227 • Number of events 1 • All-cause mortality is reported from randomization to the end of study (up to 53 months). Adverse events are reported from from the first dose to 30 days after the last dose or final cutoff on December 29, 2023, maximum treatment exposure was 232 weeks for Arm A and 157 weeks for Arm B.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
0.00%
0/229 • All-cause mortality is reported from randomization to the end of study (up to 53 months). Adverse events are reported from from the first dose to 30 days after the last dose or final cutoff on December 29, 2023, maximum treatment exposure was 232 weeks for Arm A and 157 weeks for Arm B.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
|
Cardiac disorders
Coronary artery disease
|
0.00%
0/227 • All-cause mortality is reported from randomization to the end of study (up to 53 months). Adverse events are reported from from the first dose to 30 days after the last dose or final cutoff on December 29, 2023, maximum treatment exposure was 232 weeks for Arm A and 157 weeks for Arm B.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
0.44%
1/229 • Number of events 1 • All-cause mortality is reported from randomization to the end of study (up to 53 months). Adverse events are reported from from the first dose to 30 days after the last dose or final cutoff on December 29, 2023, maximum treatment exposure was 232 weeks for Arm A and 157 weeks for Arm B.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
|
Cardiac disorders
Immune-mediated myocarditis
|
1.3%
3/227 • Number of events 3 • All-cause mortality is reported from randomization to the end of study (up to 53 months). Adverse events are reported from from the first dose to 30 days after the last dose or final cutoff on December 29, 2023, maximum treatment exposure was 232 weeks for Arm A and 157 weeks for Arm B.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
0.00%
0/229 • All-cause mortality is reported from randomization to the end of study (up to 53 months). Adverse events are reported from from the first dose to 30 days after the last dose or final cutoff on December 29, 2023, maximum treatment exposure was 232 weeks for Arm A and 157 weeks for Arm B.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
|
Cardiac disorders
Myocardial infarction
|
0.44%
1/227 • Number of events 1 • All-cause mortality is reported from randomization to the end of study (up to 53 months). Adverse events are reported from from the first dose to 30 days after the last dose or final cutoff on December 29, 2023, maximum treatment exposure was 232 weeks for Arm A and 157 weeks for Arm B.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
0.00%
0/229 • All-cause mortality is reported from randomization to the end of study (up to 53 months). Adverse events are reported from from the first dose to 30 days after the last dose or final cutoff on December 29, 2023, maximum treatment exposure was 232 weeks for Arm A and 157 weeks for Arm B.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
|
Cardiac disorders
Palpitations
|
0.44%
1/227 • Number of events 1 • All-cause mortality is reported from randomization to the end of study (up to 53 months). Adverse events are reported from from the first dose to 30 days after the last dose or final cutoff on December 29, 2023, maximum treatment exposure was 232 weeks for Arm A and 157 weeks for Arm B.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
0.00%
0/229 • All-cause mortality is reported from randomization to the end of study (up to 53 months). Adverse events are reported from from the first dose to 30 days after the last dose or final cutoff on December 29, 2023, maximum treatment exposure was 232 weeks for Arm A and 157 weeks for Arm B.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
|
Cardiac disorders
Pericardial effusion
|
0.00%
0/227 • All-cause mortality is reported from randomization to the end of study (up to 53 months). Adverse events are reported from from the first dose to 30 days after the last dose or final cutoff on December 29, 2023, maximum treatment exposure was 232 weeks for Arm A and 157 weeks for Arm B.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
0.44%
1/229 • Number of events 1 • All-cause mortality is reported from randomization to the end of study (up to 53 months). Adverse events are reported from from the first dose to 30 days after the last dose or final cutoff on December 29, 2023, maximum treatment exposure was 232 weeks for Arm A and 157 weeks for Arm B.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
|
Cardiac disorders
Supraventricular tachycardia
|
0.00%
0/227 • All-cause mortality is reported from randomization to the end of study (up to 53 months). Adverse events are reported from from the first dose to 30 days after the last dose or final cutoff on December 29, 2023, maximum treatment exposure was 232 weeks for Arm A and 157 weeks for Arm B.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
0.44%
1/229 • Number of events 1 • All-cause mortality is reported from randomization to the end of study (up to 53 months). Adverse events are reported from from the first dose to 30 days after the last dose or final cutoff on December 29, 2023, maximum treatment exposure was 232 weeks for Arm A and 157 weeks for Arm B.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
|
Ear and labyrinth disorders
Deafness neurosensory
|
0.44%
1/227 • Number of events 1 • All-cause mortality is reported from randomization to the end of study (up to 53 months). Adverse events are reported from from the first dose to 30 days after the last dose or final cutoff on December 29, 2023, maximum treatment exposure was 232 weeks for Arm A and 157 weeks for Arm B.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
0.00%
0/229 • All-cause mortality is reported from randomization to the end of study (up to 53 months). Adverse events are reported from from the first dose to 30 days after the last dose or final cutoff on December 29, 2023, maximum treatment exposure was 232 weeks for Arm A and 157 weeks for Arm B.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
|
Gastrointestinal disorders
Abdominal distension
|
0.44%
1/227 • Number of events 1 • All-cause mortality is reported from randomization to the end of study (up to 53 months). Adverse events are reported from from the first dose to 30 days after the last dose or final cutoff on December 29, 2023, maximum treatment exposure was 232 weeks for Arm A and 157 weeks for Arm B.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
0.00%
0/229 • All-cause mortality is reported from randomization to the end of study (up to 53 months). Adverse events are reported from from the first dose to 30 days after the last dose or final cutoff on December 29, 2023, maximum treatment exposure was 232 weeks for Arm A and 157 weeks for Arm B.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/227 • All-cause mortality is reported from randomization to the end of study (up to 53 months). Adverse events are reported from from the first dose to 30 days after the last dose or final cutoff on December 29, 2023, maximum treatment exposure was 232 weeks for Arm A and 157 weeks for Arm B.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
0.87%
2/229 • Number of events 2 • All-cause mortality is reported from randomization to the end of study (up to 53 months). Adverse events are reported from from the first dose to 30 days after the last dose or final cutoff on December 29, 2023, maximum treatment exposure was 232 weeks for Arm A and 157 weeks for Arm B.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/227 • All-cause mortality is reported from randomization to the end of study (up to 53 months). Adverse events are reported from from the first dose to 30 days after the last dose or final cutoff on December 29, 2023, maximum treatment exposure was 232 weeks for Arm A and 157 weeks for Arm B.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
0.44%
1/229 • Number of events 1 • All-cause mortality is reported from randomization to the end of study (up to 53 months). Adverse events are reported from from the first dose to 30 days after the last dose or final cutoff on December 29, 2023, maximum treatment exposure was 232 weeks for Arm A and 157 weeks for Arm B.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.88%
2/227 • Number of events 2 • All-cause mortality is reported from randomization to the end of study (up to 53 months). Adverse events are reported from from the first dose to 30 days after the last dose or final cutoff on December 29, 2023, maximum treatment exposure was 232 weeks for Arm A and 157 weeks for Arm B.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
0.00%
0/229 • All-cause mortality is reported from randomization to the end of study (up to 53 months). Adverse events are reported from from the first dose to 30 days after the last dose or final cutoff on December 29, 2023, maximum treatment exposure was 232 weeks for Arm A and 157 weeks for Arm B.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
|
Gastrointestinal disorders
Gastric ulcer
|
0.44%
1/227 • Number of events 1 • All-cause mortality is reported from randomization to the end of study (up to 53 months). Adverse events are reported from from the first dose to 30 days after the last dose or final cutoff on December 29, 2023, maximum treatment exposure was 232 weeks for Arm A and 157 weeks for Arm B.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
0.00%
0/229 • All-cause mortality is reported from randomization to the end of study (up to 53 months). Adverse events are reported from from the first dose to 30 days after the last dose or final cutoff on December 29, 2023, maximum treatment exposure was 232 weeks for Arm A and 157 weeks for Arm B.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.44%
1/227 • Number of events 1 • All-cause mortality is reported from randomization to the end of study (up to 53 months). Adverse events are reported from from the first dose to 30 days after the last dose or final cutoff on December 29, 2023, maximum treatment exposure was 232 weeks for Arm A and 157 weeks for Arm B.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
0.00%
0/229 • All-cause mortality is reported from randomization to the end of study (up to 53 months). Adverse events are reported from from the first dose to 30 days after the last dose or final cutoff on December 29, 2023, maximum treatment exposure was 232 weeks for Arm A and 157 weeks for Arm B.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
|
Gastrointestinal disorders
Ileus
|
1.3%
3/227 • Number of events 3 • All-cause mortality is reported from randomization to the end of study (up to 53 months). Adverse events are reported from from the first dose to 30 days after the last dose or final cutoff on December 29, 2023, maximum treatment exposure was 232 weeks for Arm A and 157 weeks for Arm B.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
0.44%
1/229 • Number of events 1 • All-cause mortality is reported from randomization to the end of study (up to 53 months). Adverse events are reported from from the first dose to 30 days after the last dose or final cutoff on December 29, 2023, maximum treatment exposure was 232 weeks for Arm A and 157 weeks for Arm B.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
|
Gastrointestinal disorders
Intestinal obstruction
|
0.88%
2/227 • Number of events 2 • All-cause mortality is reported from randomization to the end of study (up to 53 months). Adverse events are reported from from the first dose to 30 days after the last dose or final cutoff on December 29, 2023, maximum treatment exposure was 232 weeks for Arm A and 157 weeks for Arm B.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
0.00%
0/229 • All-cause mortality is reported from randomization to the end of study (up to 53 months). Adverse events are reported from from the first dose to 30 days after the last dose or final cutoff on December 29, 2023, maximum treatment exposure was 232 weeks for Arm A and 157 weeks for Arm B.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
|
Gastrointestinal disorders
Large intestine polyp
|
0.00%
0/227 • All-cause mortality is reported from randomization to the end of study (up to 53 months). Adverse events are reported from from the first dose to 30 days after the last dose or final cutoff on December 29, 2023, maximum treatment exposure was 232 weeks for Arm A and 157 weeks for Arm B.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
0.44%
1/229 • Number of events 1 • All-cause mortality is reported from randomization to the end of study (up to 53 months). Adverse events are reported from from the first dose to 30 days after the last dose or final cutoff on December 29, 2023, maximum treatment exposure was 232 weeks for Arm A and 157 weeks for Arm B.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
|
Gastrointestinal disorders
Pancreatitis acute
|
0.44%
1/227 • Number of events 1 • All-cause mortality is reported from randomization to the end of study (up to 53 months). Adverse events are reported from from the first dose to 30 days after the last dose or final cutoff on December 29, 2023, maximum treatment exposure was 232 weeks for Arm A and 157 weeks for Arm B.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
0.00%
0/229 • All-cause mortality is reported from randomization to the end of study (up to 53 months). Adverse events are reported from from the first dose to 30 days after the last dose or final cutoff on December 29, 2023, maximum treatment exposure was 232 weeks for Arm A and 157 weeks for Arm B.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
|
Gastrointestinal disorders
Subileus
|
0.44%
1/227 • Number of events 1 • All-cause mortality is reported from randomization to the end of study (up to 53 months). Adverse events are reported from from the first dose to 30 days after the last dose or final cutoff on December 29, 2023, maximum treatment exposure was 232 weeks for Arm A and 157 weeks for Arm B.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
0.00%
0/229 • All-cause mortality is reported from randomization to the end of study (up to 53 months). Adverse events are reported from from the first dose to 30 days after the last dose or final cutoff on December 29, 2023, maximum treatment exposure was 232 weeks for Arm A and 157 weeks for Arm B.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
|
General disorders
Asthenia
|
0.44%
1/227 • Number of events 1 • All-cause mortality is reported from randomization to the end of study (up to 53 months). Adverse events are reported from from the first dose to 30 days after the last dose or final cutoff on December 29, 2023, maximum treatment exposure was 232 weeks for Arm A and 157 weeks for Arm B.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
0.00%
0/229 • All-cause mortality is reported from randomization to the end of study (up to 53 months). Adverse events are reported from from the first dose to 30 days after the last dose or final cutoff on December 29, 2023, maximum treatment exposure was 232 weeks for Arm A and 157 weeks for Arm B.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
|
General disorders
Death
|
0.88%
2/227 • Number of events 2 • All-cause mortality is reported from randomization to the end of study (up to 53 months). Adverse events are reported from from the first dose to 30 days after the last dose or final cutoff on December 29, 2023, maximum treatment exposure was 232 weeks for Arm A and 157 weeks for Arm B.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
0.00%
0/229 • All-cause mortality is reported from randomization to the end of study (up to 53 months). Adverse events are reported from from the first dose to 30 days after the last dose or final cutoff on December 29, 2023, maximum treatment exposure was 232 weeks for Arm A and 157 weeks for Arm B.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
|
General disorders
Disease progression
|
0.00%
0/227 • All-cause mortality is reported from randomization to the end of study (up to 53 months). Adverse events are reported from from the first dose to 30 days after the last dose or final cutoff on December 29, 2023, maximum treatment exposure was 232 weeks for Arm A and 157 weeks for Arm B.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
0.44%
1/229 • Number of events 1 • All-cause mortality is reported from randomization to the end of study (up to 53 months). Adverse events are reported from from the first dose to 30 days after the last dose or final cutoff on December 29, 2023, maximum treatment exposure was 232 weeks for Arm A and 157 weeks for Arm B.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
|
General disorders
Fatigue
|
0.88%
2/227 • Number of events 2 • All-cause mortality is reported from randomization to the end of study (up to 53 months). Adverse events are reported from from the first dose to 30 days after the last dose or final cutoff on December 29, 2023, maximum treatment exposure was 232 weeks for Arm A and 157 weeks for Arm B.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
0.00%
0/229 • All-cause mortality is reported from randomization to the end of study (up to 53 months). Adverse events are reported from from the first dose to 30 days after the last dose or final cutoff on December 29, 2023, maximum treatment exposure was 232 weeks for Arm A and 157 weeks for Arm B.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
|
General disorders
Malaise
|
0.44%
1/227 • Number of events 1 • All-cause mortality is reported from randomization to the end of study (up to 53 months). Adverse events are reported from from the first dose to 30 days after the last dose or final cutoff on December 29, 2023, maximum treatment exposure was 232 weeks for Arm A and 157 weeks for Arm B.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
0.00%
0/229 • All-cause mortality is reported from randomization to the end of study (up to 53 months). Adverse events are reported from from the first dose to 30 days after the last dose or final cutoff on December 29, 2023, maximum treatment exposure was 232 weeks for Arm A and 157 weeks for Arm B.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
|
General disorders
Multiple organ dysfunction syndrome
|
0.44%
1/227 • Number of events 1 • All-cause mortality is reported from randomization to the end of study (up to 53 months). Adverse events are reported from from the first dose to 30 days after the last dose or final cutoff on December 29, 2023, maximum treatment exposure was 232 weeks for Arm A and 157 weeks for Arm B.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
0.00%
0/229 • All-cause mortality is reported from randomization to the end of study (up to 53 months). Adverse events are reported from from the first dose to 30 days after the last dose or final cutoff on December 29, 2023, maximum treatment exposure was 232 weeks for Arm A and 157 weeks for Arm B.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
|
General disorders
Pyrexia
|
0.88%
2/227 • Number of events 2 • All-cause mortality is reported from randomization to the end of study (up to 53 months). Adverse events are reported from from the first dose to 30 days after the last dose or final cutoff on December 29, 2023, maximum treatment exposure was 232 weeks for Arm A and 157 weeks for Arm B.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
0.00%
0/229 • All-cause mortality is reported from randomization to the end of study (up to 53 months). Adverse events are reported from from the first dose to 30 days after the last dose or final cutoff on December 29, 2023, maximum treatment exposure was 232 weeks for Arm A and 157 weeks for Arm B.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
|
Hepatobiliary disorders
Immune-mediated hepatitis
|
0.88%
2/227 • Number of events 2 • All-cause mortality is reported from randomization to the end of study (up to 53 months). Adverse events are reported from from the first dose to 30 days after the last dose or final cutoff on December 29, 2023, maximum treatment exposure was 232 weeks for Arm A and 157 weeks for Arm B.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
0.00%
0/229 • All-cause mortality is reported from randomization to the end of study (up to 53 months). Adverse events are reported from from the first dose to 30 days after the last dose or final cutoff on December 29, 2023, maximum treatment exposure was 232 weeks for Arm A and 157 weeks for Arm B.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
|
Infections and infestations
Bacteraemia
|
0.44%
1/227 • Number of events 1 • All-cause mortality is reported from randomization to the end of study (up to 53 months). Adverse events are reported from from the first dose to 30 days after the last dose or final cutoff on December 29, 2023, maximum treatment exposure was 232 weeks for Arm A and 157 weeks for Arm B.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
0.00%
0/229 • All-cause mortality is reported from randomization to the end of study (up to 53 months). Adverse events are reported from from the first dose to 30 days after the last dose or final cutoff on December 29, 2023, maximum treatment exposure was 232 weeks for Arm A and 157 weeks for Arm B.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
|
Infections and infestations
COVID-19 pneumonia
|
0.88%
2/227 • Number of events 2 • All-cause mortality is reported from randomization to the end of study (up to 53 months). Adverse events are reported from from the first dose to 30 days after the last dose or final cutoff on December 29, 2023, maximum treatment exposure was 232 weeks for Arm A and 157 weeks for Arm B.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
0.00%
0/229 • All-cause mortality is reported from randomization to the end of study (up to 53 months). Adverse events are reported from from the first dose to 30 days after the last dose or final cutoff on December 29, 2023, maximum treatment exposure was 232 weeks for Arm A and 157 weeks for Arm B.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
|
Infections and infestations
Encephalitis
|
0.00%
0/227 • All-cause mortality is reported from randomization to the end of study (up to 53 months). Adverse events are reported from from the first dose to 30 days after the last dose or final cutoff on December 29, 2023, maximum treatment exposure was 232 weeks for Arm A and 157 weeks for Arm B.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
0.44%
1/229 • Number of events 1 • All-cause mortality is reported from randomization to the end of study (up to 53 months). Adverse events are reported from from the first dose to 30 days after the last dose or final cutoff on December 29, 2023, maximum treatment exposure was 232 weeks for Arm A and 157 weeks for Arm B.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
|
Infections and infestations
Infection
|
0.00%
0/227 • All-cause mortality is reported from randomization to the end of study (up to 53 months). Adverse events are reported from from the first dose to 30 days after the last dose or final cutoff on December 29, 2023, maximum treatment exposure was 232 weeks for Arm A and 157 weeks for Arm B.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
0.44%
1/229 • Number of events 1 • All-cause mortality is reported from randomization to the end of study (up to 53 months). Adverse events are reported from from the first dose to 30 days after the last dose or final cutoff on December 29, 2023, maximum treatment exposure was 232 weeks for Arm A and 157 weeks for Arm B.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
|
Infections and infestations
Infectious pleural effusion
|
0.44%
1/227 • Number of events 1 • All-cause mortality is reported from randomization to the end of study (up to 53 months). Adverse events are reported from from the first dose to 30 days after the last dose or final cutoff on December 29, 2023, maximum treatment exposure was 232 weeks for Arm A and 157 weeks for Arm B.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
0.00%
0/229 • All-cause mortality is reported from randomization to the end of study (up to 53 months). Adverse events are reported from from the first dose to 30 days after the last dose or final cutoff on December 29, 2023, maximum treatment exposure was 232 weeks for Arm A and 157 weeks for Arm B.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
|
Infections and infestations
Phlebitis infective
|
0.44%
1/227 • Number of events 1 • All-cause mortality is reported from randomization to the end of study (up to 53 months). Adverse events are reported from from the first dose to 30 days after the last dose or final cutoff on December 29, 2023, maximum treatment exposure was 232 weeks for Arm A and 157 weeks for Arm B.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
0.00%
0/229 • All-cause mortality is reported from randomization to the end of study (up to 53 months). Adverse events are reported from from the first dose to 30 days after the last dose or final cutoff on December 29, 2023, maximum treatment exposure was 232 weeks for Arm A and 157 weeks for Arm B.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
|
Infections and infestations
Pneumonia
|
1.8%
4/227 • Number of events 4 • All-cause mortality is reported from randomization to the end of study (up to 53 months). Adverse events are reported from from the first dose to 30 days after the last dose or final cutoff on December 29, 2023, maximum treatment exposure was 232 weeks for Arm A and 157 weeks for Arm B.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
2.2%
5/229 • Number of events 5 • All-cause mortality is reported from randomization to the end of study (up to 53 months). Adverse events are reported from from the first dose to 30 days after the last dose or final cutoff on December 29, 2023, maximum treatment exposure was 232 weeks for Arm A and 157 weeks for Arm B.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
|
Infections and infestations
Sepsis
|
0.00%
0/227 • All-cause mortality is reported from randomization to the end of study (up to 53 months). Adverse events are reported from from the first dose to 30 days after the last dose or final cutoff on December 29, 2023, maximum treatment exposure was 232 weeks for Arm A and 157 weeks for Arm B.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
0.44%
1/229 • Number of events 1 • All-cause mortality is reported from randomization to the end of study (up to 53 months). Adverse events are reported from from the first dose to 30 days after the last dose or final cutoff on December 29, 2023, maximum treatment exposure was 232 weeks for Arm A and 157 weeks for Arm B.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.44%
1/227 • Number of events 1 • All-cause mortality is reported from randomization to the end of study (up to 53 months). Adverse events are reported from from the first dose to 30 days after the last dose or final cutoff on December 29, 2023, maximum treatment exposure was 232 weeks for Arm A and 157 weeks for Arm B.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
0.44%
1/229 • Number of events 1 • All-cause mortality is reported from randomization to the end of study (up to 53 months). Adverse events are reported from from the first dose to 30 days after the last dose or final cutoff on December 29, 2023, maximum treatment exposure was 232 weeks for Arm A and 157 weeks for Arm B.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
|
Infections and infestations
Upper respiratory tract infection bacterial
|
0.00%
0/227 • All-cause mortality is reported from randomization to the end of study (up to 53 months). Adverse events are reported from from the first dose to 30 days after the last dose or final cutoff on December 29, 2023, maximum treatment exposure was 232 weeks for Arm A and 157 weeks for Arm B.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
0.44%
1/229 • Number of events 1 • All-cause mortality is reported from randomization to the end of study (up to 53 months). Adverse events are reported from from the first dose to 30 days after the last dose or final cutoff on December 29, 2023, maximum treatment exposure was 232 weeks for Arm A and 157 weeks for Arm B.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
|
Infections and infestations
Urinary tract infection
|
0.44%
1/227 • Number of events 1 • All-cause mortality is reported from randomization to the end of study (up to 53 months). Adverse events are reported from from the first dose to 30 days after the last dose or final cutoff on December 29, 2023, maximum treatment exposure was 232 weeks for Arm A and 157 weeks for Arm B.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
0.00%
0/229 • All-cause mortality is reported from randomization to the end of study (up to 53 months). Adverse events are reported from from the first dose to 30 days after the last dose or final cutoff on December 29, 2023, maximum treatment exposure was 232 weeks for Arm A and 157 weeks for Arm B.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
|
Injury, poisoning and procedural complications
Ankle fracture
|
0.00%
0/227 • All-cause mortality is reported from randomization to the end of study (up to 53 months). Adverse events are reported from from the first dose to 30 days after the last dose or final cutoff on December 29, 2023, maximum treatment exposure was 232 weeks for Arm A and 157 weeks for Arm B.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
0.44%
1/229 • Number of events 1 • All-cause mortality is reported from randomization to the end of study (up to 53 months). Adverse events are reported from from the first dose to 30 days after the last dose or final cutoff on December 29, 2023, maximum treatment exposure was 232 weeks for Arm A and 157 weeks for Arm B.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/227 • All-cause mortality is reported from randomization to the end of study (up to 53 months). Adverse events are reported from from the first dose to 30 days after the last dose or final cutoff on December 29, 2023, maximum treatment exposure was 232 weeks for Arm A and 157 weeks for Arm B.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
0.44%
1/229 • Number of events 1 • All-cause mortality is reported from randomization to the end of study (up to 53 months). Adverse events are reported from from the first dose to 30 days after the last dose or final cutoff on December 29, 2023, maximum treatment exposure was 232 weeks for Arm A and 157 weeks for Arm B.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
|
Injury, poisoning and procedural complications
Femoral neck fracture
|
0.44%
1/227 • Number of events 1 • All-cause mortality is reported from randomization to the end of study (up to 53 months). Adverse events are reported from from the first dose to 30 days after the last dose or final cutoff on December 29, 2023, maximum treatment exposure was 232 weeks for Arm A and 157 weeks for Arm B.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
0.00%
0/229 • All-cause mortality is reported from randomization to the end of study (up to 53 months). Adverse events are reported from from the first dose to 30 days after the last dose or final cutoff on December 29, 2023, maximum treatment exposure was 232 weeks for Arm A and 157 weeks for Arm B.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
|
Injury, poisoning and procedural complications
Spinal fracture
|
0.44%
1/227 • Number of events 1 • All-cause mortality is reported from randomization to the end of study (up to 53 months). Adverse events are reported from from the first dose to 30 days after the last dose or final cutoff on December 29, 2023, maximum treatment exposure was 232 weeks for Arm A and 157 weeks for Arm B.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
0.00%
0/229 • All-cause mortality is reported from randomization to the end of study (up to 53 months). Adverse events are reported from from the first dose to 30 days after the last dose or final cutoff on December 29, 2023, maximum treatment exposure was 232 weeks for Arm A and 157 weeks for Arm B.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
|
Investigations
Alanine aminotransferase increased
|
1.8%
4/227 • Number of events 4 • All-cause mortality is reported from randomization to the end of study (up to 53 months). Adverse events are reported from from the first dose to 30 days after the last dose or final cutoff on December 29, 2023, maximum treatment exposure was 232 weeks for Arm A and 157 weeks for Arm B.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
0.00%
0/229 • All-cause mortality is reported from randomization to the end of study (up to 53 months). Adverse events are reported from from the first dose to 30 days after the last dose or final cutoff on December 29, 2023, maximum treatment exposure was 232 weeks for Arm A and 157 weeks for Arm B.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
|
Investigations
Aspartate aminotransferase increased
|
1.3%
3/227 • Number of events 3 • All-cause mortality is reported from randomization to the end of study (up to 53 months). Adverse events are reported from from the first dose to 30 days after the last dose or final cutoff on December 29, 2023, maximum treatment exposure was 232 weeks for Arm A and 157 weeks for Arm B.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
0.00%
0/229 • All-cause mortality is reported from randomization to the end of study (up to 53 months). Adverse events are reported from from the first dose to 30 days after the last dose or final cutoff on December 29, 2023, maximum treatment exposure was 232 weeks for Arm A and 157 weeks for Arm B.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
|
Investigations
Neutrophil count decreased
|
2.2%
5/227 • Number of events 6 • All-cause mortality is reported from randomization to the end of study (up to 53 months). Adverse events are reported from from the first dose to 30 days after the last dose or final cutoff on December 29, 2023, maximum treatment exposure was 232 weeks for Arm A and 157 weeks for Arm B.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
1.3%
3/229 • Number of events 3 • All-cause mortality is reported from randomization to the end of study (up to 53 months). Adverse events are reported from from the first dose to 30 days after the last dose or final cutoff on December 29, 2023, maximum treatment exposure was 232 weeks for Arm A and 157 weeks for Arm B.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
|
Investigations
Platelet count decreased
|
2.2%
5/227 • Number of events 6 • All-cause mortality is reported from randomization to the end of study (up to 53 months). Adverse events are reported from from the first dose to 30 days after the last dose or final cutoff on December 29, 2023, maximum treatment exposure was 232 weeks for Arm A and 157 weeks for Arm B.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
2.2%
5/229 • Number of events 6 • All-cause mortality is reported from randomization to the end of study (up to 53 months). Adverse events are reported from from the first dose to 30 days after the last dose or final cutoff on December 29, 2023, maximum treatment exposure was 232 weeks for Arm A and 157 weeks for Arm B.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
|
Investigations
Troponin T increased
|
0.44%
1/227 • Number of events 1 • All-cause mortality is reported from randomization to the end of study (up to 53 months). Adverse events are reported from from the first dose to 30 days after the last dose or final cutoff on December 29, 2023, maximum treatment exposure was 232 weeks for Arm A and 157 weeks for Arm B.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
0.00%
0/229 • All-cause mortality is reported from randomization to the end of study (up to 53 months). Adverse events are reported from from the first dose to 30 days after the last dose or final cutoff on December 29, 2023, maximum treatment exposure was 232 weeks for Arm A and 157 weeks for Arm B.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
|
Investigations
White blood cell count decreased
|
2.2%
5/227 • Number of events 5 • All-cause mortality is reported from randomization to the end of study (up to 53 months). Adverse events are reported from from the first dose to 30 days after the last dose or final cutoff on December 29, 2023, maximum treatment exposure was 232 weeks for Arm A and 157 weeks for Arm B.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
1.3%
3/229 • Number of events 3 • All-cause mortality is reported from randomization to the end of study (up to 53 months). Adverse events are reported from from the first dose to 30 days after the last dose or final cutoff on December 29, 2023, maximum treatment exposure was 232 weeks for Arm A and 157 weeks for Arm B.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.44%
1/227 • Number of events 1 • All-cause mortality is reported from randomization to the end of study (up to 53 months). Adverse events are reported from from the first dose to 30 days after the last dose or final cutoff on December 29, 2023, maximum treatment exposure was 232 weeks for Arm A and 157 weeks for Arm B.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
0.00%
0/229 • All-cause mortality is reported from randomization to the end of study (up to 53 months). Adverse events are reported from from the first dose to 30 days after the last dose or final cutoff on December 29, 2023, maximum treatment exposure was 232 weeks for Arm A and 157 weeks for Arm B.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
0.88%
2/227 • Number of events 2 • All-cause mortality is reported from randomization to the end of study (up to 53 months). Adverse events are reported from from the first dose to 30 days after the last dose or final cutoff on December 29, 2023, maximum treatment exposure was 232 weeks for Arm A and 157 weeks for Arm B.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
0.00%
0/229 • All-cause mortality is reported from randomization to the end of study (up to 53 months). Adverse events are reported from from the first dose to 30 days after the last dose or final cutoff on December 29, 2023, maximum treatment exposure was 232 weeks for Arm A and 157 weeks for Arm B.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
|
Metabolism and nutrition disorders
Diabetic ketosis
|
0.44%
1/227 • Number of events 2 • All-cause mortality is reported from randomization to the end of study (up to 53 months). Adverse events are reported from from the first dose to 30 days after the last dose or final cutoff on December 29, 2023, maximum treatment exposure was 232 weeks for Arm A and 157 weeks for Arm B.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
0.00%
0/229 • All-cause mortality is reported from randomization to the end of study (up to 53 months). Adverse events are reported from from the first dose to 30 days after the last dose or final cutoff on December 29, 2023, maximum treatment exposure was 232 weeks for Arm A and 157 weeks for Arm B.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
|
Metabolism and nutrition disorders
Electrolyte imbalance
|
0.00%
0/227 • All-cause mortality is reported from randomization to the end of study (up to 53 months). Adverse events are reported from from the first dose to 30 days after the last dose or final cutoff on December 29, 2023, maximum treatment exposure was 232 weeks for Arm A and 157 weeks for Arm B.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
0.44%
1/229 • Number of events 1 • All-cause mortality is reported from randomization to the end of study (up to 53 months). Adverse events are reported from from the first dose to 30 days after the last dose or final cutoff on December 29, 2023, maximum treatment exposure was 232 weeks for Arm A and 157 weeks for Arm B.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.88%
2/227 • Number of events 2 • All-cause mortality is reported from randomization to the end of study (up to 53 months). Adverse events are reported from from the first dose to 30 days after the last dose or final cutoff on December 29, 2023, maximum treatment exposure was 232 weeks for Arm A and 157 weeks for Arm B.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
0.87%
2/229 • Number of events 2 • All-cause mortality is reported from randomization to the end of study (up to 53 months). Adverse events are reported from from the first dose to 30 days after the last dose or final cutoff on December 29, 2023, maximum treatment exposure was 232 weeks for Arm A and 157 weeks for Arm B.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
|
Metabolism and nutrition disorders
Hyperuricaemia
|
0.44%
1/227 • Number of events 1 • All-cause mortality is reported from randomization to the end of study (up to 53 months). Adverse events are reported from from the first dose to 30 days after the last dose or final cutoff on December 29, 2023, maximum treatment exposure was 232 weeks for Arm A and 157 weeks for Arm B.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
0.00%
0/229 • All-cause mortality is reported from randomization to the end of study (up to 53 months). Adverse events are reported from from the first dose to 30 days after the last dose or final cutoff on December 29, 2023, maximum treatment exposure was 232 weeks for Arm A and 157 weeks for Arm B.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
2.2%
5/227 • Number of events 6 • All-cause mortality is reported from randomization to the end of study (up to 53 months). Adverse events are reported from from the first dose to 30 days after the last dose or final cutoff on December 29, 2023, maximum treatment exposure was 232 weeks for Arm A and 157 weeks for Arm B.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
0.44%
1/229 • Number of events 1 • All-cause mortality is reported from randomization to the end of study (up to 53 months). Adverse events are reported from from the first dose to 30 days after the last dose or final cutoff on December 29, 2023, maximum treatment exposure was 232 weeks for Arm A and 157 weeks for Arm B.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
|
Metabolism and nutrition disorders
Type 1 diabetes mellitus
|
0.88%
2/227 • Number of events 2 • All-cause mortality is reported from randomization to the end of study (up to 53 months). Adverse events are reported from from the first dose to 30 days after the last dose or final cutoff on December 29, 2023, maximum treatment exposure was 232 weeks for Arm A and 157 weeks for Arm B.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
0.00%
0/229 • All-cause mortality is reported from randomization to the end of study (up to 53 months). Adverse events are reported from from the first dose to 30 days after the last dose or final cutoff on December 29, 2023, maximum treatment exposure was 232 weeks for Arm A and 157 weeks for Arm B.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
|
Metabolism and nutrition disorders
Type 2 diabetes mellitus
|
0.44%
1/227 • Number of events 1 • All-cause mortality is reported from randomization to the end of study (up to 53 months). Adverse events are reported from from the first dose to 30 days after the last dose or final cutoff on December 29, 2023, maximum treatment exposure was 232 weeks for Arm A and 157 weeks for Arm B.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
0.00%
0/229 • All-cause mortality is reported from randomization to the end of study (up to 53 months). Adverse events are reported from from the first dose to 30 days after the last dose or final cutoff on December 29, 2023, maximum treatment exposure was 232 weeks for Arm A and 157 weeks for Arm B.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.44%
1/227 • Number of events 1 • All-cause mortality is reported from randomization to the end of study (up to 53 months). Adverse events are reported from from the first dose to 30 days after the last dose or final cutoff on December 29, 2023, maximum treatment exposure was 232 weeks for Arm A and 157 weeks for Arm B.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
0.00%
0/229 • All-cause mortality is reported from randomization to the end of study (up to 53 months). Adverse events are reported from from the first dose to 30 days after the last dose or final cutoff on December 29, 2023, maximum treatment exposure was 232 weeks for Arm A and 157 weeks for Arm B.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
0.44%
1/227 • Number of events 1 • All-cause mortality is reported from randomization to the end of study (up to 53 months). Adverse events are reported from from the first dose to 30 days after the last dose or final cutoff on December 29, 2023, maximum treatment exposure was 232 weeks for Arm A and 157 weeks for Arm B.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
0.44%
1/229 • Number of events 1 • All-cause mortality is reported from randomization to the end of study (up to 53 months). Adverse events are reported from from the first dose to 30 days after the last dose or final cutoff on December 29, 2023, maximum treatment exposure was 232 weeks for Arm A and 157 weeks for Arm B.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.00%
0/227 • All-cause mortality is reported from randomization to the end of study (up to 53 months). Adverse events are reported from from the first dose to 30 days after the last dose or final cutoff on December 29, 2023, maximum treatment exposure was 232 weeks for Arm A and 157 weeks for Arm B.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
0.44%
1/229 • Number of events 1 • All-cause mortality is reported from randomization to the end of study (up to 53 months). Adverse events are reported from from the first dose to 30 days after the last dose or final cutoff on December 29, 2023, maximum treatment exposure was 232 weeks for Arm A and 157 weeks for Arm B.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/227 • All-cause mortality is reported from randomization to the end of study (up to 53 months). Adverse events are reported from from the first dose to 30 days after the last dose or final cutoff on December 29, 2023, maximum treatment exposure was 232 weeks for Arm A and 157 weeks for Arm B.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
0.44%
1/229 • Number of events 1 • All-cause mortality is reported from randomization to the end of study (up to 53 months). Adverse events are reported from from the first dose to 30 days after the last dose or final cutoff on December 29, 2023, maximum treatment exposure was 232 weeks for Arm A and 157 weeks for Arm B.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cancer pain
|
0.00%
0/227 • All-cause mortality is reported from randomization to the end of study (up to 53 months). Adverse events are reported from from the first dose to 30 days after the last dose or final cutoff on December 29, 2023, maximum treatment exposure was 232 weeks for Arm A and 157 weeks for Arm B.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
0.87%
2/229 • Number of events 2 • All-cause mortality is reported from randomization to the end of study (up to 53 months). Adverse events are reported from from the first dose to 30 days after the last dose or final cutoff on December 29, 2023, maximum treatment exposure was 232 weeks for Arm A and 157 weeks for Arm B.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Paraneoplastic syndrome
|
0.00%
0/227 • All-cause mortality is reported from randomization to the end of study (up to 53 months). Adverse events are reported from from the first dose to 30 days after the last dose or final cutoff on December 29, 2023, maximum treatment exposure was 232 weeks for Arm A and 157 weeks for Arm B.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
0.44%
1/229 • Number of events 1 • All-cause mortality is reported from randomization to the end of study (up to 53 months). Adverse events are reported from from the first dose to 30 days after the last dose or final cutoff on December 29, 2023, maximum treatment exposure was 232 weeks for Arm A and 157 weeks for Arm B.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Rectal cancer
|
0.44%
1/227 • Number of events 1 • All-cause mortality is reported from randomization to the end of study (up to 53 months). Adverse events are reported from from the first dose to 30 days after the last dose or final cutoff on December 29, 2023, maximum treatment exposure was 232 weeks for Arm A and 157 weeks for Arm B.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
0.00%
0/229 • All-cause mortality is reported from randomization to the end of study (up to 53 months). Adverse events are reported from from the first dose to 30 days after the last dose or final cutoff on December 29, 2023, maximum treatment exposure was 232 weeks for Arm A and 157 weeks for Arm B.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma of skin
|
0.44%
1/227 • Number of events 1 • All-cause mortality is reported from randomization to the end of study (up to 53 months). Adverse events are reported from from the first dose to 30 days after the last dose or final cutoff on December 29, 2023, maximum treatment exposure was 232 weeks for Arm A and 157 weeks for Arm B.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
0.00%
0/229 • All-cause mortality is reported from randomization to the end of study (up to 53 months). Adverse events are reported from from the first dose to 30 days after the last dose or final cutoff on December 29, 2023, maximum treatment exposure was 232 weeks for Arm A and 157 weeks for Arm B.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour associated fever
|
0.00%
0/227 • All-cause mortality is reported from randomization to the end of study (up to 53 months). Adverse events are reported from from the first dose to 30 days after the last dose or final cutoff on December 29, 2023, maximum treatment exposure was 232 weeks for Arm A and 157 weeks for Arm B.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
0.44%
1/229 • Number of events 1 • All-cause mortality is reported from randomization to the end of study (up to 53 months). Adverse events are reported from from the first dose to 30 days after the last dose or final cutoff on December 29, 2023, maximum treatment exposure was 232 weeks for Arm A and 157 weeks for Arm B.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
|
Nervous system disorders
Brain oedema
|
0.44%
1/227 • Number of events 1 • All-cause mortality is reported from randomization to the end of study (up to 53 months). Adverse events are reported from from the first dose to 30 days after the last dose or final cutoff on December 29, 2023, maximum treatment exposure was 232 weeks for Arm A and 157 weeks for Arm B.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
0.00%
0/229 • All-cause mortality is reported from randomization to the end of study (up to 53 months). Adverse events are reported from from the first dose to 30 days after the last dose or final cutoff on December 29, 2023, maximum treatment exposure was 232 weeks for Arm A and 157 weeks for Arm B.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
|
Nervous system disorders
Cerebral infarction
|
0.44%
1/227 • Number of events 1 • All-cause mortality is reported from randomization to the end of study (up to 53 months). Adverse events are reported from from the first dose to 30 days after the last dose or final cutoff on December 29, 2023, maximum treatment exposure was 232 weeks for Arm A and 157 weeks for Arm B.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
0.44%
1/229 • Number of events 1 • All-cause mortality is reported from randomization to the end of study (up to 53 months). Adverse events are reported from from the first dose to 30 days after the last dose or final cutoff on December 29, 2023, maximum treatment exposure was 232 weeks for Arm A and 157 weeks for Arm B.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
|
Nervous system disorders
Cerebrovascular accident
|
0.00%
0/227 • All-cause mortality is reported from randomization to the end of study (up to 53 months). Adverse events are reported from from the first dose to 30 days after the last dose or final cutoff on December 29, 2023, maximum treatment exposure was 232 weeks for Arm A and 157 weeks for Arm B.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
0.44%
1/229 • Number of events 1 • All-cause mortality is reported from randomization to the end of study (up to 53 months). Adverse events are reported from from the first dose to 30 days after the last dose or final cutoff on December 29, 2023, maximum treatment exposure was 232 weeks for Arm A and 157 weeks for Arm B.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
|
Nervous system disorders
Depressed level of consciousness
|
0.88%
2/227 • Number of events 2 • All-cause mortality is reported from randomization to the end of study (up to 53 months). Adverse events are reported from from the first dose to 30 days after the last dose or final cutoff on December 29, 2023, maximum treatment exposure was 232 weeks for Arm A and 157 weeks for Arm B.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
0.00%
0/229 • All-cause mortality is reported from randomization to the end of study (up to 53 months). Adverse events are reported from from the first dose to 30 days after the last dose or final cutoff on December 29, 2023, maximum treatment exposure was 232 weeks for Arm A and 157 weeks for Arm B.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
|
Nervous system disorders
Epilepsy
|
0.44%
1/227 • Number of events 1 • All-cause mortality is reported from randomization to the end of study (up to 53 months). Adverse events are reported from from the first dose to 30 days after the last dose or final cutoff on December 29, 2023, maximum treatment exposure was 232 weeks for Arm A and 157 weeks for Arm B.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
0.00%
0/229 • All-cause mortality is reported from randomization to the end of study (up to 53 months). Adverse events are reported from from the first dose to 30 days after the last dose or final cutoff on December 29, 2023, maximum treatment exposure was 232 weeks for Arm A and 157 weeks for Arm B.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
|
Nervous system disorders
Intracranial pressure increased
|
0.00%
0/227 • All-cause mortality is reported from randomization to the end of study (up to 53 months). Adverse events are reported from from the first dose to 30 days after the last dose or final cutoff on December 29, 2023, maximum treatment exposure was 232 weeks for Arm A and 157 weeks for Arm B.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
0.44%
1/229 • Number of events 1 • All-cause mortality is reported from randomization to the end of study (up to 53 months). Adverse events are reported from from the first dose to 30 days after the last dose or final cutoff on December 29, 2023, maximum treatment exposure was 232 weeks for Arm A and 157 weeks for Arm B.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
|
Nervous system disorders
Meningitis noninfective
|
0.44%
1/227 • Number of events 1 • All-cause mortality is reported from randomization to the end of study (up to 53 months). Adverse events are reported from from the first dose to 30 days after the last dose or final cutoff on December 29, 2023, maximum treatment exposure was 232 weeks for Arm A and 157 weeks for Arm B.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
0.00%
0/229 • All-cause mortality is reported from randomization to the end of study (up to 53 months). Adverse events are reported from from the first dose to 30 days after the last dose or final cutoff on December 29, 2023, maximum treatment exposure was 232 weeks for Arm A and 157 weeks for Arm B.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
|
Nervous system disorders
Neuritis
|
0.00%
0/227 • All-cause mortality is reported from randomization to the end of study (up to 53 months). Adverse events are reported from from the first dose to 30 days after the last dose or final cutoff on December 29, 2023, maximum treatment exposure was 232 weeks for Arm A and 157 weeks for Arm B.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
0.44%
1/229 • Number of events 1 • All-cause mortality is reported from randomization to the end of study (up to 53 months). Adverse events are reported from from the first dose to 30 days after the last dose or final cutoff on December 29, 2023, maximum treatment exposure was 232 weeks for Arm A and 157 weeks for Arm B.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
|
Nervous system disorders
Neuropathy peripheral
|
0.88%
2/227 • Number of events 2 • All-cause mortality is reported from randomization to the end of study (up to 53 months). Adverse events are reported from from the first dose to 30 days after the last dose or final cutoff on December 29, 2023, maximum treatment exposure was 232 weeks for Arm A and 157 weeks for Arm B.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
0.00%
0/229 • All-cause mortality is reported from randomization to the end of study (up to 53 months). Adverse events are reported from from the first dose to 30 days after the last dose or final cutoff on December 29, 2023, maximum treatment exposure was 232 weeks for Arm A and 157 weeks for Arm B.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
|
Nervous system disorders
Secondary cerebellar degeneration
|
0.44%
1/227 • Number of events 1 • All-cause mortality is reported from randomization to the end of study (up to 53 months). Adverse events are reported from from the first dose to 30 days after the last dose or final cutoff on December 29, 2023, maximum treatment exposure was 232 weeks for Arm A and 157 weeks for Arm B.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
0.00%
0/229 • All-cause mortality is reported from randomization to the end of study (up to 53 months). Adverse events are reported from from the first dose to 30 days after the last dose or final cutoff on December 29, 2023, maximum treatment exposure was 232 weeks for Arm A and 157 weeks for Arm B.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
|
Renal and urinary disorders
Ureterolithiasis
|
0.44%
1/227 • Number of events 1 • All-cause mortality is reported from randomization to the end of study (up to 53 months). Adverse events are reported from from the first dose to 30 days after the last dose or final cutoff on December 29, 2023, maximum treatment exposure was 232 weeks for Arm A and 157 weeks for Arm B.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
0.00%
0/229 • All-cause mortality is reported from randomization to the end of study (up to 53 months). Adverse events are reported from from the first dose to 30 days after the last dose or final cutoff on December 29, 2023, maximum treatment exposure was 232 weeks for Arm A and 157 weeks for Arm B.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.44%
1/227 • Number of events 2 • All-cause mortality is reported from randomization to the end of study (up to 53 months). Adverse events are reported from from the first dose to 30 days after the last dose or final cutoff on December 29, 2023, maximum treatment exposure was 232 weeks for Arm A and 157 weeks for Arm B.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
0.00%
0/229 • All-cause mortality is reported from randomization to the end of study (up to 53 months). Adverse events are reported from from the first dose to 30 days after the last dose or final cutoff on December 29, 2023, maximum treatment exposure was 232 weeks for Arm A and 157 weeks for Arm B.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/227 • All-cause mortality is reported from randomization to the end of study (up to 53 months). Adverse events are reported from from the first dose to 30 days after the last dose or final cutoff on December 29, 2023, maximum treatment exposure was 232 weeks for Arm A and 157 weeks for Arm B.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
0.44%
1/229 • Number of events 1 • All-cause mortality is reported from randomization to the end of study (up to 53 months). Adverse events are reported from from the first dose to 30 days after the last dose or final cutoff on December 29, 2023, maximum treatment exposure was 232 weeks for Arm A and 157 weeks for Arm B.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.88%
2/227 • Number of events 2 • All-cause mortality is reported from randomization to the end of study (up to 53 months). Adverse events are reported from from the first dose to 30 days after the last dose or final cutoff on December 29, 2023, maximum treatment exposure was 232 weeks for Arm A and 157 weeks for Arm B.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
0.00%
0/229 • All-cause mortality is reported from randomization to the end of study (up to 53 months). Adverse events are reported from from the first dose to 30 days after the last dose or final cutoff on December 29, 2023, maximum treatment exposure was 232 weeks for Arm A and 157 weeks for Arm B.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
0.88%
2/227 • Number of events 2 • All-cause mortality is reported from randomization to the end of study (up to 53 months). Adverse events are reported from from the first dose to 30 days after the last dose or final cutoff on December 29, 2023, maximum treatment exposure was 232 weeks for Arm A and 157 weeks for Arm B.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
2.2%
5/229 • Number of events 5 • All-cause mortality is reported from randomization to the end of study (up to 53 months). Adverse events are reported from from the first dose to 30 days after the last dose or final cutoff on December 29, 2023, maximum treatment exposure was 232 weeks for Arm A and 157 weeks for Arm B.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Immune-mediated lung disease
|
0.00%
0/227 • All-cause mortality is reported from randomization to the end of study (up to 53 months). Adverse events are reported from from the first dose to 30 days after the last dose or final cutoff on December 29, 2023, maximum treatment exposure was 232 weeks for Arm A and 157 weeks for Arm B.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
0.44%
1/229 • Number of events 1 • All-cause mortality is reported from randomization to the end of study (up to 53 months). Adverse events are reported from from the first dose to 30 days after the last dose or final cutoff on December 29, 2023, maximum treatment exposure was 232 weeks for Arm A and 157 weeks for Arm B.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Interstitial lung disease
|
0.44%
1/227 • Number of events 1 • All-cause mortality is reported from randomization to the end of study (up to 53 months). Adverse events are reported from from the first dose to 30 days after the last dose or final cutoff on December 29, 2023, maximum treatment exposure was 232 weeks for Arm A and 157 weeks for Arm B.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
0.44%
1/229 • Number of events 1 • All-cause mortality is reported from randomization to the end of study (up to 53 months). Adverse events are reported from from the first dose to 30 days after the last dose or final cutoff on December 29, 2023, maximum treatment exposure was 232 weeks for Arm A and 157 weeks for Arm B.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.44%
1/227 • Number of events 1 • All-cause mortality is reported from randomization to the end of study (up to 53 months). Adverse events are reported from from the first dose to 30 days after the last dose or final cutoff on December 29, 2023, maximum treatment exposure was 232 weeks for Arm A and 157 weeks for Arm B.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
0.00%
0/229 • All-cause mortality is reported from randomization to the end of study (up to 53 months). Adverse events are reported from from the first dose to 30 days after the last dose or final cutoff on December 29, 2023, maximum treatment exposure was 232 weeks for Arm A and 157 weeks for Arm B.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
1.8%
4/227 • Number of events 4 • All-cause mortality is reported from randomization to the end of study (up to 53 months). Adverse events are reported from from the first dose to 30 days after the last dose or final cutoff on December 29, 2023, maximum treatment exposure was 232 weeks for Arm A and 157 weeks for Arm B.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
0.00%
0/229 • All-cause mortality is reported from randomization to the end of study (up to 53 months). Adverse events are reported from from the first dose to 30 days after the last dose or final cutoff on December 29, 2023, maximum treatment exposure was 232 weeks for Arm A and 157 weeks for Arm B.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.44%
1/227 • Number of events 1 • All-cause mortality is reported from randomization to the end of study (up to 53 months). Adverse events are reported from from the first dose to 30 days after the last dose or final cutoff on December 29, 2023, maximum treatment exposure was 232 weeks for Arm A and 157 weeks for Arm B.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
0.44%
1/229 • Number of events 1 • All-cause mortality is reported from randomization to the end of study (up to 53 months). Adverse events are reported from from the first dose to 30 days after the last dose or final cutoff on December 29, 2023, maximum treatment exposure was 232 weeks for Arm A and 157 weeks for Arm B.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Tachypnoea
|
0.00%
0/227 • All-cause mortality is reported from randomization to the end of study (up to 53 months). Adverse events are reported from from the first dose to 30 days after the last dose or final cutoff on December 29, 2023, maximum treatment exposure was 232 weeks for Arm A and 157 weeks for Arm B.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
0.44%
1/229 • Number of events 1 • All-cause mortality is reported from randomization to the end of study (up to 53 months). Adverse events are reported from from the first dose to 30 days after the last dose or final cutoff on December 29, 2023, maximum treatment exposure was 232 weeks for Arm A and 157 weeks for Arm B.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
|
Skin and subcutaneous tissue disorders
Immune-mediated dermatitis
|
0.44%
1/227 • Number of events 1 • All-cause mortality is reported from randomization to the end of study (up to 53 months). Adverse events are reported from from the first dose to 30 days after the last dose or final cutoff on December 29, 2023, maximum treatment exposure was 232 weeks for Arm A and 157 weeks for Arm B.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
0.00%
0/229 • All-cause mortality is reported from randomization to the end of study (up to 53 months). Adverse events are reported from from the first dose to 30 days after the last dose or final cutoff on December 29, 2023, maximum treatment exposure was 232 weeks for Arm A and 157 weeks for Arm B.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
|
Skin and subcutaneous tissue disorders
Psoriasis
|
0.44%
1/227 • Number of events 1 • All-cause mortality is reported from randomization to the end of study (up to 53 months). Adverse events are reported from from the first dose to 30 days after the last dose or final cutoff on December 29, 2023, maximum treatment exposure was 232 weeks for Arm A and 157 weeks for Arm B.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
0.00%
0/229 • All-cause mortality is reported from randomization to the end of study (up to 53 months). Adverse events are reported from from the first dose to 30 days after the last dose or final cutoff on December 29, 2023, maximum treatment exposure was 232 weeks for Arm A and 157 weeks for Arm B.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
|
Vascular disorders
Circulatory collapse
|
0.00%
0/227 • All-cause mortality is reported from randomization to the end of study (up to 53 months). Adverse events are reported from from the first dose to 30 days after the last dose or final cutoff on December 29, 2023, maximum treatment exposure was 232 weeks for Arm A and 157 weeks for Arm B.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
0.44%
1/229 • Number of events 1 • All-cause mortality is reported from randomization to the end of study (up to 53 months). Adverse events are reported from from the first dose to 30 days after the last dose or final cutoff on December 29, 2023, maximum treatment exposure was 232 weeks for Arm A and 157 weeks for Arm B.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
|
Vascular disorders
Hypertension
|
0.00%
0/227 • All-cause mortality is reported from randomization to the end of study (up to 53 months). Adverse events are reported from from the first dose to 30 days after the last dose or final cutoff on December 29, 2023, maximum treatment exposure was 232 weeks for Arm A and 157 weeks for Arm B.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
0.44%
1/229 • Number of events 1 • All-cause mortality is reported from randomization to the end of study (up to 53 months). Adverse events are reported from from the first dose to 30 days after the last dose or final cutoff on December 29, 2023, maximum treatment exposure was 232 weeks for Arm A and 157 weeks for Arm B.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
|
Vascular disorders
Superior vena cava syndrome
|
0.00%
0/227 • All-cause mortality is reported from randomization to the end of study (up to 53 months). Adverse events are reported from from the first dose to 30 days after the last dose or final cutoff on December 29, 2023, maximum treatment exposure was 232 weeks for Arm A and 157 weeks for Arm B.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
0.44%
1/229 • Number of events 1 • All-cause mortality is reported from randomization to the end of study (up to 53 months). Adverse events are reported from from the first dose to 30 days after the last dose or final cutoff on December 29, 2023, maximum treatment exposure was 232 weeks for Arm A and 157 weeks for Arm B.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
|
Vascular disorders
Vena cava thrombosis
|
0.00%
0/227 • All-cause mortality is reported from randomization to the end of study (up to 53 months). Adverse events are reported from from the first dose to 30 days after the last dose or final cutoff on December 29, 2023, maximum treatment exposure was 232 weeks for Arm A and 157 weeks for Arm B.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
0.44%
1/229 • Number of events 1 • All-cause mortality is reported from randomization to the end of study (up to 53 months). Adverse events are reported from from the first dose to 30 days after the last dose or final cutoff on December 29, 2023, maximum treatment exposure was 232 weeks for Arm A and 157 weeks for Arm B.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
Other adverse events
| Measure |
Arm A: Tislelizumab + Chemotherapy
n=227 participants at risk
Participants received tislelizumab with cisplatin or carboplatin and etoposide every 3 weeks for 4 cycles, then transitioned to maintenance tislelizumab every 3 weeks. Tislelizumab (200 mg) was administered on Day 1 of each cycle. Cisplatin (75 mg/m²) or carboplatin (AUC 5 mg/mL/min) was given on Day 1, and etoposide (100 mg/m²) on Days 1 to 3, with all chemotherapy discontinued after Cycle 4.
|
Arm B: Placebo + Chemotherapy
n=229 participants at risk
Participants received a placebo (matching the tislelizumab dose) with cisplatin or carboplatin and etoposide every 3 weeks for 4 cycles, then transitioned to maintenance placebo every 3 weeks. Cisplatin (75 mg/m²) or carboplatin (AUC 5 mg/mL/min) was given on Day 1, and etoposide (100 mg/m²) on Days 1 to 3, with all chemotherapy discontinued after Cycle 4.
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
84.6%
192/227 • Number of events 356 • All-cause mortality is reported from randomization to the end of study (up to 53 months). Adverse events are reported from from the first dose to 30 days after the last dose or final cutoff on December 29, 2023, maximum treatment exposure was 232 weeks for Arm A and 157 weeks for Arm B.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
83.4%
191/229 • Number of events 329 • All-cause mortality is reported from randomization to the end of study (up to 53 months). Adverse events are reported from from the first dose to 30 days after the last dose or final cutoff on December 29, 2023, maximum treatment exposure was 232 weeks for Arm A and 157 weeks for Arm B.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
|
Blood and lymphatic system disorders
Leukopenia
|
32.6%
74/227 • Number of events 205 • All-cause mortality is reported from randomization to the end of study (up to 53 months). Adverse events are reported from from the first dose to 30 days after the last dose or final cutoff on December 29, 2023, maximum treatment exposure was 232 weeks for Arm A and 157 weeks for Arm B.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
24.0%
55/229 • Number of events 173 • All-cause mortality is reported from randomization to the end of study (up to 53 months). Adverse events are reported from from the first dose to 30 days after the last dose or final cutoff on December 29, 2023, maximum treatment exposure was 232 weeks for Arm A and 157 weeks for Arm B.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
|
Blood and lymphatic system disorders
Neutropenia
|
65.6%
149/227 • Number of events 445 • All-cause mortality is reported from randomization to the end of study (up to 53 months). Adverse events are reported from from the first dose to 30 days after the last dose or final cutoff on December 29, 2023, maximum treatment exposure was 232 weeks for Arm A and 157 weeks for Arm B.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
68.6%
157/229 • Number of events 492 • All-cause mortality is reported from randomization to the end of study (up to 53 months). Adverse events are reported from from the first dose to 30 days after the last dose or final cutoff on December 29, 2023, maximum treatment exposure was 232 weeks for Arm A and 157 weeks for Arm B.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
47.6%
108/227 • Number of events 247 • All-cause mortality is reported from randomization to the end of study (up to 53 months). Adverse events are reported from from the first dose to 30 days after the last dose or final cutoff on December 29, 2023, maximum treatment exposure was 232 weeks for Arm A and 157 weeks for Arm B.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
49.8%
114/229 • Number of events 248 • All-cause mortality is reported from randomization to the end of study (up to 53 months). Adverse events are reported from from the first dose to 30 days after the last dose or final cutoff on December 29, 2023, maximum treatment exposure was 232 weeks for Arm A and 157 weeks for Arm B.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
|
Cardiac disorders
Sinus tachycardia
|
4.4%
10/227 • Number of events 13 • All-cause mortality is reported from randomization to the end of study (up to 53 months). Adverse events are reported from from the first dose to 30 days after the last dose or final cutoff on December 29, 2023, maximum treatment exposure was 232 weeks for Arm A and 157 weeks for Arm B.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
0.00%
0/229 • All-cause mortality is reported from randomization to the end of study (up to 53 months). Adverse events are reported from from the first dose to 30 days after the last dose or final cutoff on December 29, 2023, maximum treatment exposure was 232 weeks for Arm A and 157 weeks for Arm B.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
|
Endocrine disorders
Hyperthyroidism
|
7.5%
17/227 • Number of events 21 • All-cause mortality is reported from randomization to the end of study (up to 53 months). Adverse events are reported from from the first dose to 30 days after the last dose or final cutoff on December 29, 2023, maximum treatment exposure was 232 weeks for Arm A and 157 weeks for Arm B.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
0.44%
1/229 • Number of events 1 • All-cause mortality is reported from randomization to the end of study (up to 53 months). Adverse events are reported from from the first dose to 30 days after the last dose or final cutoff on December 29, 2023, maximum treatment exposure was 232 weeks for Arm A and 157 weeks for Arm B.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
|
Endocrine disorders
Hypothyroidism
|
12.3%
28/227 • Number of events 38 • All-cause mortality is reported from randomization to the end of study (up to 53 months). Adverse events are reported from from the first dose to 30 days after the last dose or final cutoff on December 29, 2023, maximum treatment exposure was 232 weeks for Arm A and 157 weeks for Arm B.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
3.9%
9/229 • Number of events 10 • All-cause mortality is reported from randomization to the end of study (up to 53 months). Adverse events are reported from from the first dose to 30 days after the last dose or final cutoff on December 29, 2023, maximum treatment exposure was 232 weeks for Arm A and 157 weeks for Arm B.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
|
Gastrointestinal disorders
Abdominal distension
|
6.2%
14/227 • Number of events 15 • All-cause mortality is reported from randomization to the end of study (up to 53 months). Adverse events are reported from from the first dose to 30 days after the last dose or final cutoff on December 29, 2023, maximum treatment exposure was 232 weeks for Arm A and 157 weeks for Arm B.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
3.5%
8/229 • Number of events 10 • All-cause mortality is reported from randomization to the end of study (up to 53 months). Adverse events are reported from from the first dose to 30 days after the last dose or final cutoff on December 29, 2023, maximum treatment exposure was 232 weeks for Arm A and 157 weeks for Arm B.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
|
Gastrointestinal disorders
Abdominal pain
|
3.1%
7/227 • Number of events 8 • All-cause mortality is reported from randomization to the end of study (up to 53 months). Adverse events are reported from from the first dose to 30 days after the last dose or final cutoff on December 29, 2023, maximum treatment exposure was 232 weeks for Arm A and 157 weeks for Arm B.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
2.2%
5/229 • Number of events 5 • All-cause mortality is reported from randomization to the end of study (up to 53 months). Adverse events are reported from from the first dose to 30 days after the last dose or final cutoff on December 29, 2023, maximum treatment exposure was 232 weeks for Arm A and 157 weeks for Arm B.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
7.0%
16/227 • Number of events 20 • All-cause mortality is reported from randomization to the end of study (up to 53 months). Adverse events are reported from from the first dose to 30 days after the last dose or final cutoff on December 29, 2023, maximum treatment exposure was 232 weeks for Arm A and 157 weeks for Arm B.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
3.1%
7/229 • Number of events 8 • All-cause mortality is reported from randomization to the end of study (up to 53 months). Adverse events are reported from from the first dose to 30 days after the last dose or final cutoff on December 29, 2023, maximum treatment exposure was 232 weeks for Arm A and 157 weeks for Arm B.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
|
Gastrointestinal disorders
Constipation
|
37.0%
84/227 • Number of events 136 • All-cause mortality is reported from randomization to the end of study (up to 53 months). Adverse events are reported from from the first dose to 30 days after the last dose or final cutoff on December 29, 2023, maximum treatment exposure was 232 weeks for Arm A and 157 weeks for Arm B.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
25.3%
58/229 • Number of events 84 • All-cause mortality is reported from randomization to the end of study (up to 53 months). Adverse events are reported from from the first dose to 30 days after the last dose or final cutoff on December 29, 2023, maximum treatment exposure was 232 weeks for Arm A and 157 weeks for Arm B.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
|
Gastrointestinal disorders
Diarrhoea
|
15.9%
36/227 • Number of events 49 • All-cause mortality is reported from randomization to the end of study (up to 53 months). Adverse events are reported from from the first dose to 30 days after the last dose or final cutoff on December 29, 2023, maximum treatment exposure was 232 weeks for Arm A and 157 weeks for Arm B.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
13.5%
31/229 • Number of events 38 • All-cause mortality is reported from randomization to the end of study (up to 53 months). Adverse events are reported from from the first dose to 30 days after the last dose or final cutoff on December 29, 2023, maximum treatment exposure was 232 weeks for Arm A and 157 weeks for Arm B.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
|
Gastrointestinal disorders
Dysphagia
|
2.2%
5/227 • Number of events 5 • All-cause mortality is reported from randomization to the end of study (up to 53 months). Adverse events are reported from from the first dose to 30 days after the last dose or final cutoff on December 29, 2023, maximum treatment exposure was 232 weeks for Arm A and 157 weeks for Arm B.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
3.1%
7/229 • Number of events 10 • All-cause mortality is reported from randomization to the end of study (up to 53 months). Adverse events are reported from from the first dose to 30 days after the last dose or final cutoff on December 29, 2023, maximum treatment exposure was 232 weeks for Arm A and 157 weeks for Arm B.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
|
Gastrointestinal disorders
Gingival pain
|
4.4%
10/227 • Number of events 10 • All-cause mortality is reported from randomization to the end of study (up to 53 months). Adverse events are reported from from the first dose to 30 days after the last dose or final cutoff on December 29, 2023, maximum treatment exposure was 232 weeks for Arm A and 157 weeks for Arm B.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
0.00%
0/229 • All-cause mortality is reported from randomization to the end of study (up to 53 months). Adverse events are reported from from the first dose to 30 days after the last dose or final cutoff on December 29, 2023, maximum treatment exposure was 232 weeks for Arm A and 157 weeks for Arm B.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
|
Gastrointestinal disorders
Mouth ulceration
|
3.1%
7/227 • Number of events 8 • All-cause mortality is reported from randomization to the end of study (up to 53 months). Adverse events are reported from from the first dose to 30 days after the last dose or final cutoff on December 29, 2023, maximum treatment exposure was 232 weeks for Arm A and 157 weeks for Arm B.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
0.00%
0/229 • All-cause mortality is reported from randomization to the end of study (up to 53 months). Adverse events are reported from from the first dose to 30 days after the last dose or final cutoff on December 29, 2023, maximum treatment exposure was 232 weeks for Arm A and 157 weeks for Arm B.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
|
Gastrointestinal disorders
Nausea
|
44.5%
101/227 • Number of events 193 • All-cause mortality is reported from randomization to the end of study (up to 53 months). Adverse events are reported from from the first dose to 30 days after the last dose or final cutoff on December 29, 2023, maximum treatment exposure was 232 weeks for Arm A and 157 weeks for Arm B.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
43.7%
100/229 • Number of events 171 • All-cause mortality is reported from randomization to the end of study (up to 53 months). Adverse events are reported from from the first dose to 30 days after the last dose or final cutoff on December 29, 2023, maximum treatment exposure was 232 weeks for Arm A and 157 weeks for Arm B.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
|
Gastrointestinal disorders
Oral pain
|
0.88%
2/227 • Number of events 2 • All-cause mortality is reported from randomization to the end of study (up to 53 months). Adverse events are reported from from the first dose to 30 days after the last dose or final cutoff on December 29, 2023, maximum treatment exposure was 232 weeks for Arm A and 157 weeks for Arm B.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
3.5%
8/229 • Number of events 14 • All-cause mortality is reported from randomization to the end of study (up to 53 months). Adverse events are reported from from the first dose to 30 days after the last dose or final cutoff on December 29, 2023, maximum treatment exposure was 232 weeks for Arm A and 157 weeks for Arm B.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
|
Gastrointestinal disorders
Toothache
|
4.8%
11/227 • Number of events 16 • All-cause mortality is reported from randomization to the end of study (up to 53 months). Adverse events are reported from from the first dose to 30 days after the last dose or final cutoff on December 29, 2023, maximum treatment exposure was 232 weeks for Arm A and 157 weeks for Arm B.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
3.1%
7/229 • Number of events 7 • All-cause mortality is reported from randomization to the end of study (up to 53 months). Adverse events are reported from from the first dose to 30 days after the last dose or final cutoff on December 29, 2023, maximum treatment exposure was 232 weeks for Arm A and 157 weeks for Arm B.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
|
Gastrointestinal disorders
Vomiting
|
24.7%
56/227 • Number of events 93 • All-cause mortality is reported from randomization to the end of study (up to 53 months). Adverse events are reported from from the first dose to 30 days after the last dose or final cutoff on December 29, 2023, maximum treatment exposure was 232 weeks for Arm A and 157 weeks for Arm B.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
23.6%
54/229 • Number of events 85 • All-cause mortality is reported from randomization to the end of study (up to 53 months). Adverse events are reported from from the first dose to 30 days after the last dose or final cutoff on December 29, 2023, maximum treatment exposure was 232 weeks for Arm A and 157 weeks for Arm B.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
|
General disorders
Asthenia
|
7.5%
17/227 • Number of events 20 • All-cause mortality is reported from randomization to the end of study (up to 53 months). Adverse events are reported from from the first dose to 30 days after the last dose or final cutoff on December 29, 2023, maximum treatment exposure was 232 weeks for Arm A and 157 weeks for Arm B.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
7.0%
16/229 • Number of events 19 • All-cause mortality is reported from randomization to the end of study (up to 53 months). Adverse events are reported from from the first dose to 30 days after the last dose or final cutoff on December 29, 2023, maximum treatment exposure was 232 weeks for Arm A and 157 weeks for Arm B.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
|
General disorders
Chest discomfort
|
6.2%
14/227 • Number of events 19 • All-cause mortality is reported from randomization to the end of study (up to 53 months). Adverse events are reported from from the first dose to 30 days after the last dose or final cutoff on December 29, 2023, maximum treatment exposure was 232 weeks for Arm A and 157 weeks for Arm B.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
2.6%
6/229 • Number of events 6 • All-cause mortality is reported from randomization to the end of study (up to 53 months). Adverse events are reported from from the first dose to 30 days after the last dose or final cutoff on December 29, 2023, maximum treatment exposure was 232 weeks for Arm A and 157 weeks for Arm B.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
|
General disorders
Face oedema
|
4.0%
9/227 • Number of events 9 • All-cause mortality is reported from randomization to the end of study (up to 53 months). Adverse events are reported from from the first dose to 30 days after the last dose or final cutoff on December 29, 2023, maximum treatment exposure was 232 weeks for Arm A and 157 weeks for Arm B.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
1.3%
3/229 • Number of events 3 • All-cause mortality is reported from randomization to the end of study (up to 53 months). Adverse events are reported from from the first dose to 30 days after the last dose or final cutoff on December 29, 2023, maximum treatment exposure was 232 weeks for Arm A and 157 weeks for Arm B.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
|
General disorders
Fatigue
|
11.9%
27/227 • Number of events 33 • All-cause mortality is reported from randomization to the end of study (up to 53 months). Adverse events are reported from from the first dose to 30 days after the last dose or final cutoff on December 29, 2023, maximum treatment exposure was 232 weeks for Arm A and 157 weeks for Arm B.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
6.1%
14/229 • Number of events 15 • All-cause mortality is reported from randomization to the end of study (up to 53 months). Adverse events are reported from from the first dose to 30 days after the last dose or final cutoff on December 29, 2023, maximum treatment exposure was 232 weeks for Arm A and 157 weeks for Arm B.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
|
General disorders
Malaise
|
12.8%
29/227 • Number of events 42 • All-cause mortality is reported from randomization to the end of study (up to 53 months). Adverse events are reported from from the first dose to 30 days after the last dose or final cutoff on December 29, 2023, maximum treatment exposure was 232 weeks for Arm A and 157 weeks for Arm B.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
13.5%
31/229 • Number of events 40 • All-cause mortality is reported from randomization to the end of study (up to 53 months). Adverse events are reported from from the first dose to 30 days after the last dose or final cutoff on December 29, 2023, maximum treatment exposure was 232 weeks for Arm A and 157 weeks for Arm B.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
|
General disorders
Non-cardiac chest pain
|
7.9%
18/227 • Number of events 22 • All-cause mortality is reported from randomization to the end of study (up to 53 months). Adverse events are reported from from the first dose to 30 days after the last dose or final cutoff on December 29, 2023, maximum treatment exposure was 232 weeks for Arm A and 157 weeks for Arm B.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
7.4%
17/229 • Number of events 18 • All-cause mortality is reported from randomization to the end of study (up to 53 months). Adverse events are reported from from the first dose to 30 days after the last dose or final cutoff on December 29, 2023, maximum treatment exposure was 232 weeks for Arm A and 157 weeks for Arm B.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
|
General disorders
Oedema peripheral
|
4.8%
11/227 • Number of events 12 • All-cause mortality is reported from randomization to the end of study (up to 53 months). Adverse events are reported from from the first dose to 30 days after the last dose or final cutoff on December 29, 2023, maximum treatment exposure was 232 weeks for Arm A and 157 weeks for Arm B.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
4.8%
11/229 • Number of events 13 • All-cause mortality is reported from randomization to the end of study (up to 53 months). Adverse events are reported from from the first dose to 30 days after the last dose or final cutoff on December 29, 2023, maximum treatment exposure was 232 weeks for Arm A and 157 weeks for Arm B.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
|
General disorders
Pyrexia
|
13.2%
30/227 • Number of events 35 • All-cause mortality is reported from randomization to the end of study (up to 53 months). Adverse events are reported from from the first dose to 30 days after the last dose or final cutoff on December 29, 2023, maximum treatment exposure was 232 weeks for Arm A and 157 weeks for Arm B.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
7.4%
17/229 • Number of events 22 • All-cause mortality is reported from randomization to the end of study (up to 53 months). Adverse events are reported from from the first dose to 30 days after the last dose or final cutoff on December 29, 2023, maximum treatment exposure was 232 weeks for Arm A and 157 weeks for Arm B.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
|
Infections and infestations
Pneumonia
|
2.2%
5/227 • Number of events 6 • All-cause mortality is reported from randomization to the end of study (up to 53 months). Adverse events are reported from from the first dose to 30 days after the last dose or final cutoff on December 29, 2023, maximum treatment exposure was 232 weeks for Arm A and 157 weeks for Arm B.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
5.7%
13/229 • Number of events 13 • All-cause mortality is reported from randomization to the end of study (up to 53 months). Adverse events are reported from from the first dose to 30 days after the last dose or final cutoff on December 29, 2023, maximum treatment exposure was 232 weeks for Arm A and 157 weeks for Arm B.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
|
Infections and infestations
Upper respiratory tract infection
|
7.5%
17/227 • Number of events 25 • All-cause mortality is reported from randomization to the end of study (up to 53 months). Adverse events are reported from from the first dose to 30 days after the last dose or final cutoff on December 29, 2023, maximum treatment exposure was 232 weeks for Arm A and 157 weeks for Arm B.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
3.9%
9/229 • Number of events 9 • All-cause mortality is reported from randomization to the end of study (up to 53 months). Adverse events are reported from from the first dose to 30 days after the last dose or final cutoff on December 29, 2023, maximum treatment exposure was 232 weeks for Arm A and 157 weeks for Arm B.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
3.5%
8/227 • Number of events 10 • All-cause mortality is reported from randomization to the end of study (up to 53 months). Adverse events are reported from from the first dose to 30 days after the last dose or final cutoff on December 29, 2023, maximum treatment exposure was 232 weeks for Arm A and 157 weeks for Arm B.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
2.2%
5/229 • Number of events 5 • All-cause mortality is reported from randomization to the end of study (up to 53 months). Adverse events are reported from from the first dose to 30 days after the last dose or final cutoff on December 29, 2023, maximum treatment exposure was 232 weeks for Arm A and 157 weeks for Arm B.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
|
Investigations
Alanine aminotransferase increased
|
29.5%
67/227 • Number of events 129 • All-cause mortality is reported from randomization to the end of study (up to 53 months). Adverse events are reported from from the first dose to 30 days after the last dose or final cutoff on December 29, 2023, maximum treatment exposure was 232 weeks for Arm A and 157 weeks for Arm B.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
20.1%
46/229 • Number of events 62 • All-cause mortality is reported from randomization to the end of study (up to 53 months). Adverse events are reported from from the first dose to 30 days after the last dose or final cutoff on December 29, 2023, maximum treatment exposure was 232 weeks for Arm A and 157 weeks for Arm B.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
|
Investigations
Aspartate aminotransferase increased
|
22.5%
51/227 • Number of events 85 • All-cause mortality is reported from randomization to the end of study (up to 53 months). Adverse events are reported from from the first dose to 30 days after the last dose or final cutoff on December 29, 2023, maximum treatment exposure was 232 weeks for Arm A and 157 weeks for Arm B.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
15.3%
35/229 • Number of events 60 • All-cause mortality is reported from randomization to the end of study (up to 53 months). Adverse events are reported from from the first dose to 30 days after the last dose or final cutoff on December 29, 2023, maximum treatment exposure was 232 weeks for Arm A and 157 weeks for Arm B.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
|
Investigations
Bilirubin conjugated increased
|
3.1%
7/227 • Number of events 10 • All-cause mortality is reported from randomization to the end of study (up to 53 months). Adverse events are reported from from the first dose to 30 days after the last dose or final cutoff on December 29, 2023, maximum treatment exposure was 232 weeks for Arm A and 157 weeks for Arm B.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
1.7%
4/229 • Number of events 4 • All-cause mortality is reported from randomization to the end of study (up to 53 months). Adverse events are reported from from the first dose to 30 days after the last dose or final cutoff on December 29, 2023, maximum treatment exposure was 232 weeks for Arm A and 157 weeks for Arm B.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
|
Investigations
Blood alkaline phosphatase increased
|
5.7%
13/227 • Number of events 19 • All-cause mortality is reported from randomization to the end of study (up to 53 months). Adverse events are reported from from the first dose to 30 days after the last dose or final cutoff on December 29, 2023, maximum treatment exposure was 232 weeks for Arm A and 157 weeks for Arm B.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
4.8%
11/229 • Number of events 14 • All-cause mortality is reported from randomization to the end of study (up to 53 months). Adverse events are reported from from the first dose to 30 days after the last dose or final cutoff on December 29, 2023, maximum treatment exposure was 232 weeks for Arm A and 157 weeks for Arm B.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
|
Investigations
Blood bilirubin increased
|
7.0%
16/227 • Number of events 32 • All-cause mortality is reported from randomization to the end of study (up to 53 months). Adverse events are reported from from the first dose to 30 days after the last dose or final cutoff on December 29, 2023, maximum treatment exposure was 232 weeks for Arm A and 157 weeks for Arm B.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
3.1%
7/229 • Number of events 11 • All-cause mortality is reported from randomization to the end of study (up to 53 months). Adverse events are reported from from the first dose to 30 days after the last dose or final cutoff on December 29, 2023, maximum treatment exposure was 232 weeks for Arm A and 157 weeks for Arm B.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
|
Investigations
Blood creatine phosphokinase MB increased
|
4.8%
11/227 • Number of events 15 • All-cause mortality is reported from randomization to the end of study (up to 53 months). Adverse events are reported from from the first dose to 30 days after the last dose or final cutoff on December 29, 2023, maximum treatment exposure was 232 weeks for Arm A and 157 weeks for Arm B.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
3.9%
9/229 • Number of events 11 • All-cause mortality is reported from randomization to the end of study (up to 53 months). Adverse events are reported from from the first dose to 30 days after the last dose or final cutoff on December 29, 2023, maximum treatment exposure was 232 weeks for Arm A and 157 weeks for Arm B.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
|
Investigations
Blood creatine phosphokinase increased
|
11.5%
26/227 • Number of events 48 • All-cause mortality is reported from randomization to the end of study (up to 53 months). Adverse events are reported from from the first dose to 30 days after the last dose or final cutoff on December 29, 2023, maximum treatment exposure was 232 weeks for Arm A and 157 weeks for Arm B.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
2.6%
6/229 • Number of events 12 • All-cause mortality is reported from randomization to the end of study (up to 53 months). Adverse events are reported from from the first dose to 30 days after the last dose or final cutoff on December 29, 2023, maximum treatment exposure was 232 weeks for Arm A and 157 weeks for Arm B.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
|
Investigations
Blood creatinine increased
|
8.4%
19/227 • Number of events 31 • All-cause mortality is reported from randomization to the end of study (up to 53 months). Adverse events are reported from from the first dose to 30 days after the last dose or final cutoff on December 29, 2023, maximum treatment exposure was 232 weeks for Arm A and 157 weeks for Arm B.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
6.1%
14/229 • Number of events 26 • All-cause mortality is reported from randomization to the end of study (up to 53 months). Adverse events are reported from from the first dose to 30 days after the last dose or final cutoff on December 29, 2023, maximum treatment exposure was 232 weeks for Arm A and 157 weeks for Arm B.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
|
Investigations
Blood lactate dehydrogenase increased
|
6.2%
14/227 • Number of events 16 • All-cause mortality is reported from randomization to the end of study (up to 53 months). Adverse events are reported from from the first dose to 30 days after the last dose or final cutoff on December 29, 2023, maximum treatment exposure was 232 weeks for Arm A and 157 weeks for Arm B.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
5.2%
12/229 • Number of events 18 • All-cause mortality is reported from randomization to the end of study (up to 53 months). Adverse events are reported from from the first dose to 30 days after the last dose or final cutoff on December 29, 2023, maximum treatment exposure was 232 weeks for Arm A and 157 weeks for Arm B.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
|
Investigations
Fibrin D dimer increased
|
2.2%
5/227 • Number of events 6 • All-cause mortality is reported from randomization to the end of study (up to 53 months). Adverse events are reported from from the first dose to 30 days after the last dose or final cutoff on December 29, 2023, maximum treatment exposure was 232 weeks for Arm A and 157 weeks for Arm B.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
3.1%
7/229 • Number of events 7 • All-cause mortality is reported from randomization to the end of study (up to 53 months). Adverse events are reported from from the first dose to 30 days after the last dose or final cutoff on December 29, 2023, maximum treatment exposure was 232 weeks for Arm A and 157 weeks for Arm B.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
|
Investigations
Gamma-glutamyltransferase increased
|
11.9%
27/227 • Number of events 45 • All-cause mortality is reported from randomization to the end of study (up to 53 months). Adverse events are reported from from the first dose to 30 days after the last dose or final cutoff on December 29, 2023, maximum treatment exposure was 232 weeks for Arm A and 157 weeks for Arm B.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
9.2%
21/229 • Number of events 30 • All-cause mortality is reported from randomization to the end of study (up to 53 months). Adverse events are reported from from the first dose to 30 days after the last dose or final cutoff on December 29, 2023, maximum treatment exposure was 232 weeks for Arm A and 157 weeks for Arm B.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
|
Investigations
Lymphocyte count decreased
|
11.0%
25/227 • Number of events 68 • All-cause mortality is reported from randomization to the end of study (up to 53 months). Adverse events are reported from from the first dose to 30 days after the last dose or final cutoff on December 29, 2023, maximum treatment exposure was 232 weeks for Arm A and 157 weeks for Arm B.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
12.2%
28/229 • Number of events 62 • All-cause mortality is reported from randomization to the end of study (up to 53 months). Adverse events are reported from from the first dose to 30 days after the last dose or final cutoff on December 29, 2023, maximum treatment exposure was 232 weeks for Arm A and 157 weeks for Arm B.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
|
Investigations
Neutrophil count decreased
|
22.0%
50/227 • Number of events 151 • All-cause mortality is reported from randomization to the end of study (up to 53 months). Adverse events are reported from from the first dose to 30 days after the last dose or final cutoff on December 29, 2023, maximum treatment exposure was 232 weeks for Arm A and 157 weeks for Arm B.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
24.5%
56/229 • Number of events 220 • All-cause mortality is reported from randomization to the end of study (up to 53 months). Adverse events are reported from from the first dose to 30 days after the last dose or final cutoff on December 29, 2023, maximum treatment exposure was 232 weeks for Arm A and 157 weeks for Arm B.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
|
Investigations
Platelet count decreased
|
13.7%
31/227 • Number of events 52 • All-cause mortality is reported from randomization to the end of study (up to 53 months). Adverse events are reported from from the first dose to 30 days after the last dose or final cutoff on December 29, 2023, maximum treatment exposure was 232 weeks for Arm A and 157 weeks for Arm B.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
15.3%
35/229 • Number of events 80 • All-cause mortality is reported from randomization to the end of study (up to 53 months). Adverse events are reported from from the first dose to 30 days after the last dose or final cutoff on December 29, 2023, maximum treatment exposure was 232 weeks for Arm A and 157 weeks for Arm B.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
|
Investigations
Weight decreased
|
10.6%
24/227 • Number of events 26 • All-cause mortality is reported from randomization to the end of study (up to 53 months). Adverse events are reported from from the first dose to 30 days after the last dose or final cutoff on December 29, 2023, maximum treatment exposure was 232 weeks for Arm A and 157 weeks for Arm B.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
5.2%
12/229 • Number of events 12 • All-cause mortality is reported from randomization to the end of study (up to 53 months). Adverse events are reported from from the first dose to 30 days after the last dose or final cutoff on December 29, 2023, maximum treatment exposure was 232 weeks for Arm A and 157 weeks for Arm B.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
|
Investigations
Weight increased
|
8.4%
19/227 • Number of events 27 • All-cause mortality is reported from randomization to the end of study (up to 53 months). Adverse events are reported from from the first dose to 30 days after the last dose or final cutoff on December 29, 2023, maximum treatment exposure was 232 weeks for Arm A and 157 weeks for Arm B.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
3.5%
8/229 • Number of events 8 • All-cause mortality is reported from randomization to the end of study (up to 53 months). Adverse events are reported from from the first dose to 30 days after the last dose or final cutoff on December 29, 2023, maximum treatment exposure was 232 weeks for Arm A and 157 weeks for Arm B.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
|
Investigations
White blood cell count decreased
|
55.5%
126/227 • Number of events 388 • All-cause mortality is reported from randomization to the end of study (up to 53 months). Adverse events are reported from from the first dose to 30 days after the last dose or final cutoff on December 29, 2023, maximum treatment exposure was 232 weeks for Arm A and 157 weeks for Arm B.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
64.2%
147/229 • Number of events 478 • All-cause mortality is reported from randomization to the end of study (up to 53 months). Adverse events are reported from from the first dose to 30 days after the last dose or final cutoff on December 29, 2023, maximum treatment exposure was 232 weeks for Arm A and 157 weeks for Arm B.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
38.8%
88/227 • Number of events 149 • All-cause mortality is reported from randomization to the end of study (up to 53 months). Adverse events are reported from from the first dose to 30 days after the last dose or final cutoff on December 29, 2023, maximum treatment exposure was 232 weeks for Arm A and 157 weeks for Arm B.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
37.6%
86/229 • Number of events 141 • All-cause mortality is reported from randomization to the end of study (up to 53 months). Adverse events are reported from from the first dose to 30 days after the last dose or final cutoff on December 29, 2023, maximum treatment exposure was 232 weeks for Arm A and 157 weeks for Arm B.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
|
Metabolism and nutrition disorders
Hypercholesterolaemia
|
4.8%
11/227 • Number of events 21 • All-cause mortality is reported from randomization to the end of study (up to 53 months). Adverse events are reported from from the first dose to 30 days after the last dose or final cutoff on December 29, 2023, maximum treatment exposure was 232 weeks for Arm A and 157 weeks for Arm B.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
6.1%
14/229 • Number of events 23 • All-cause mortality is reported from randomization to the end of study (up to 53 months). Adverse events are reported from from the first dose to 30 days after the last dose or final cutoff on December 29, 2023, maximum treatment exposure was 232 weeks for Arm A and 157 weeks for Arm B.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
12.3%
28/227 • Number of events 65 • All-cause mortality is reported from randomization to the end of study (up to 53 months). Adverse events are reported from from the first dose to 30 days after the last dose or final cutoff on December 29, 2023, maximum treatment exposure was 232 weeks for Arm A and 157 weeks for Arm B.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
9.6%
22/229 • Number of events 35 • All-cause mortality is reported from randomization to the end of study (up to 53 months). Adverse events are reported from from the first dose to 30 days after the last dose or final cutoff on December 29, 2023, maximum treatment exposure was 232 weeks for Arm A and 157 weeks for Arm B.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
|
Metabolism and nutrition disorders
Hypertriglyceridaemia
|
9.7%
22/227 • Number of events 51 • All-cause mortality is reported from randomization to the end of study (up to 53 months). Adverse events are reported from from the first dose to 30 days after the last dose or final cutoff on December 29, 2023, maximum treatment exposure was 232 weeks for Arm A and 157 weeks for Arm B.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
8.3%
19/229 • Number of events 29 • All-cause mortality is reported from randomization to the end of study (up to 53 months). Adverse events are reported from from the first dose to 30 days after the last dose or final cutoff on December 29, 2023, maximum treatment exposure was 232 weeks for Arm A and 157 weeks for Arm B.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
|
Metabolism and nutrition disorders
Hyperuricaemia
|
13.7%
31/227 • Number of events 61 • All-cause mortality is reported from randomization to the end of study (up to 53 months). Adverse events are reported from from the first dose to 30 days after the last dose or final cutoff on December 29, 2023, maximum treatment exposure was 232 weeks for Arm A and 157 weeks for Arm B.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
9.6%
22/229 • Number of events 32 • All-cause mortality is reported from randomization to the end of study (up to 53 months). Adverse events are reported from from the first dose to 30 days after the last dose or final cutoff on December 29, 2023, maximum treatment exposure was 232 weeks for Arm A and 157 weeks for Arm B.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
23.8%
54/227 • Number of events 83 • All-cause mortality is reported from randomization to the end of study (up to 53 months). Adverse events are reported from from the first dose to 30 days after the last dose or final cutoff on December 29, 2023, maximum treatment exposure was 232 weeks for Arm A and 157 weeks for Arm B.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
19.2%
44/229 • Number of events 69 • All-cause mortality is reported from randomization to the end of study (up to 53 months). Adverse events are reported from from the first dose to 30 days after the last dose or final cutoff on December 29, 2023, maximum treatment exposure was 232 weeks for Arm A and 157 weeks for Arm B.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
8.4%
19/227 • Number of events 25 • All-cause mortality is reported from randomization to the end of study (up to 53 months). Adverse events are reported from from the first dose to 30 days after the last dose or final cutoff on December 29, 2023, maximum treatment exposure was 232 weeks for Arm A and 157 weeks for Arm B.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
5.2%
12/229 • Number of events 13 • All-cause mortality is reported from randomization to the end of study (up to 53 months). Adverse events are reported from from the first dose to 30 days after the last dose or final cutoff on December 29, 2023, maximum treatment exposure was 232 weeks for Arm A and 157 weeks for Arm B.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
|
Metabolism and nutrition disorders
Hypochloraemia
|
8.8%
20/227 • Number of events 27 • All-cause mortality is reported from randomization to the end of study (up to 53 months). Adverse events are reported from from the first dose to 30 days after the last dose or final cutoff on December 29, 2023, maximum treatment exposure was 232 weeks for Arm A and 157 weeks for Arm B.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
5.7%
13/229 • Number of events 14 • All-cause mortality is reported from randomization to the end of study (up to 53 months). Adverse events are reported from from the first dose to 30 days after the last dose or final cutoff on December 29, 2023, maximum treatment exposure was 232 weeks for Arm A and 157 weeks for Arm B.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
17.2%
39/227 • Number of events 82 • All-cause mortality is reported from randomization to the end of study (up to 53 months). Adverse events are reported from from the first dose to 30 days after the last dose or final cutoff on December 29, 2023, maximum treatment exposure was 232 weeks for Arm A and 157 weeks for Arm B.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
8.3%
19/229 • Number of events 26 • All-cause mortality is reported from randomization to the end of study (up to 53 months). Adverse events are reported from from the first dose to 30 days after the last dose or final cutoff on December 29, 2023, maximum treatment exposure was 232 weeks for Arm A and 157 weeks for Arm B.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
4.8%
11/227 • Number of events 25 • All-cause mortality is reported from randomization to the end of study (up to 53 months). Adverse events are reported from from the first dose to 30 days after the last dose or final cutoff on December 29, 2023, maximum treatment exposure was 232 weeks for Arm A and 157 weeks for Arm B.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
1.7%
4/229 • Number of events 4 • All-cause mortality is reported from randomization to the end of study (up to 53 months). Adverse events are reported from from the first dose to 30 days after the last dose or final cutoff on December 29, 2023, maximum treatment exposure was 232 weeks for Arm A and 157 weeks for Arm B.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
24.2%
55/227 • Number of events 88 • All-cause mortality is reported from randomization to the end of study (up to 53 months). Adverse events are reported from from the first dose to 30 days after the last dose or final cutoff on December 29, 2023, maximum treatment exposure was 232 weeks for Arm A and 157 weeks for Arm B.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
24.5%
56/229 • Number of events 83 • All-cause mortality is reported from randomization to the end of study (up to 53 months). Adverse events are reported from from the first dose to 30 days after the last dose or final cutoff on December 29, 2023, maximum treatment exposure was 232 weeks for Arm A and 157 weeks for Arm B.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
4.0%
9/227 • Number of events 27 • All-cause mortality is reported from randomization to the end of study (up to 53 months). Adverse events are reported from from the first dose to 30 days after the last dose or final cutoff on December 29, 2023, maximum treatment exposure was 232 weeks for Arm A and 157 weeks for Arm B.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
3.5%
8/229 • Number of events 11 • All-cause mortality is reported from randomization to the end of study (up to 53 months). Adverse events are reported from from the first dose to 30 days after the last dose or final cutoff on December 29, 2023, maximum treatment exposure was 232 weeks for Arm A and 157 weeks for Arm B.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
15.0%
34/227 • Number of events 44 • All-cause mortality is reported from randomization to the end of study (up to 53 months). Adverse events are reported from from the first dose to 30 days after the last dose or final cutoff on December 29, 2023, maximum treatment exposure was 232 weeks for Arm A and 157 weeks for Arm B.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
7.9%
18/229 • Number of events 23 • All-cause mortality is reported from randomization to the end of study (up to 53 months). Adverse events are reported from from the first dose to 30 days after the last dose or final cutoff on December 29, 2023, maximum treatment exposure was 232 weeks for Arm A and 157 weeks for Arm B.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
7.5%
17/227 • Number of events 20 • All-cause mortality is reported from randomization to the end of study (up to 53 months). Adverse events are reported from from the first dose to 30 days after the last dose or final cutoff on December 29, 2023, maximum treatment exposure was 232 weeks for Arm A and 157 weeks for Arm B.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
9.6%
22/229 • Number of events 25 • All-cause mortality is reported from randomization to the end of study (up to 53 months). Adverse events are reported from from the first dose to 30 days after the last dose or final cutoff on December 29, 2023, maximum treatment exposure was 232 weeks for Arm A and 157 weeks for Arm B.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
11.5%
26/227 • Number of events 35 • All-cause mortality is reported from randomization to the end of study (up to 53 months). Adverse events are reported from from the first dose to 30 days after the last dose or final cutoff on December 29, 2023, maximum treatment exposure was 232 weeks for Arm A and 157 weeks for Arm B.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
7.9%
18/229 • Number of events 27 • All-cause mortality is reported from randomization to the end of study (up to 53 months). Adverse events are reported from from the first dose to 30 days after the last dose or final cutoff on December 29, 2023, maximum treatment exposure was 232 weeks for Arm A and 157 weeks for Arm B.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cancer pain
|
4.0%
9/227 • Number of events 13 • All-cause mortality is reported from randomization to the end of study (up to 53 months). Adverse events are reported from from the first dose to 30 days after the last dose or final cutoff on December 29, 2023, maximum treatment exposure was 232 weeks for Arm A and 157 weeks for Arm B.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
6.1%
14/229 • Number of events 20 • All-cause mortality is reported from randomization to the end of study (up to 53 months). Adverse events are reported from from the first dose to 30 days after the last dose or final cutoff on December 29, 2023, maximum treatment exposure was 232 weeks for Arm A and 157 weeks for Arm B.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour pain
|
4.4%
10/227 • Number of events 17 • All-cause mortality is reported from randomization to the end of study (up to 53 months). Adverse events are reported from from the first dose to 30 days after the last dose or final cutoff on December 29, 2023, maximum treatment exposure was 232 weeks for Arm A and 157 weeks for Arm B.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
5.2%
12/229 • Number of events 17 • All-cause mortality is reported from randomization to the end of study (up to 53 months). Adverse events are reported from from the first dose to 30 days after the last dose or final cutoff on December 29, 2023, maximum treatment exposure was 232 weeks for Arm A and 157 weeks for Arm B.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
|
Nervous system disorders
Dizziness
|
10.6%
24/227 • Number of events 33 • All-cause mortality is reported from randomization to the end of study (up to 53 months). Adverse events are reported from from the first dose to 30 days after the last dose or final cutoff on December 29, 2023, maximum treatment exposure was 232 weeks for Arm A and 157 weeks for Arm B.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
8.3%
19/229 • Number of events 21 • All-cause mortality is reported from randomization to the end of study (up to 53 months). Adverse events are reported from from the first dose to 30 days after the last dose or final cutoff on December 29, 2023, maximum treatment exposure was 232 weeks for Arm A and 157 weeks for Arm B.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
|
Nervous system disorders
Headache
|
10.1%
23/227 • Number of events 27 • All-cause mortality is reported from randomization to the end of study (up to 53 months). Adverse events are reported from from the first dose to 30 days after the last dose or final cutoff on December 29, 2023, maximum treatment exposure was 232 weeks for Arm A and 157 weeks for Arm B.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
4.8%
11/229 • Number of events 12 • All-cause mortality is reported from randomization to the end of study (up to 53 months). Adverse events are reported from from the first dose to 30 days after the last dose or final cutoff on December 29, 2023, maximum treatment exposure was 232 weeks for Arm A and 157 weeks for Arm B.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
|
Nervous system disorders
Hypoaesthesia
|
4.4%
10/227 • Number of events 13 • All-cause mortality is reported from randomization to the end of study (up to 53 months). Adverse events are reported from from the first dose to 30 days after the last dose or final cutoff on December 29, 2023, maximum treatment exposure was 232 weeks for Arm A and 157 weeks for Arm B.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
1.7%
4/229 • Number of events 4 • All-cause mortality is reported from randomization to the end of study (up to 53 months). Adverse events are reported from from the first dose to 30 days after the last dose or final cutoff on December 29, 2023, maximum treatment exposure was 232 weeks for Arm A and 157 weeks for Arm B.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
|
Psychiatric disorders
Insomnia
|
17.2%
39/227 • Number of events 58 • All-cause mortality is reported from randomization to the end of study (up to 53 months). Adverse events are reported from from the first dose to 30 days after the last dose or final cutoff on December 29, 2023, maximum treatment exposure was 232 weeks for Arm A and 157 weeks for Arm B.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
11.4%
26/229 • Number of events 33 • All-cause mortality is reported from randomization to the end of study (up to 53 months). Adverse events are reported from from the first dose to 30 days after the last dose or final cutoff on December 29, 2023, maximum treatment exposure was 232 weeks for Arm A and 157 weeks for Arm B.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
16.3%
37/227 • Number of events 41 • All-cause mortality is reported from randomization to the end of study (up to 53 months). Adverse events are reported from from the first dose to 30 days after the last dose or final cutoff on December 29, 2023, maximum treatment exposure was 232 weeks for Arm A and 157 weeks for Arm B.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
11.8%
27/229 • Number of events 33 • All-cause mortality is reported from randomization to the end of study (up to 53 months). Adverse events are reported from from the first dose to 30 days after the last dose or final cutoff on December 29, 2023, maximum treatment exposure was 232 weeks for Arm A and 157 weeks for Arm B.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
10.6%
24/227 • Number of events 27 • All-cause mortality is reported from randomization to the end of study (up to 53 months). Adverse events are reported from from the first dose to 30 days after the last dose or final cutoff on December 29, 2023, maximum treatment exposure was 232 weeks for Arm A and 157 weeks for Arm B.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
11.8%
27/229 • Number of events 27 • All-cause mortality is reported from randomization to the end of study (up to 53 months). Adverse events are reported from from the first dose to 30 days after the last dose or final cutoff on December 29, 2023, maximum treatment exposure was 232 weeks for Arm A and 157 weeks for Arm B.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
10.1%
23/227 • Number of events 31 • All-cause mortality is reported from randomization to the end of study (up to 53 months). Adverse events are reported from from the first dose to 30 days after the last dose or final cutoff on December 29, 2023, maximum treatment exposure was 232 weeks for Arm A and 157 weeks for Arm B.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
10.9%
25/229 • Number of events 32 • All-cause mortality is reported from randomization to the end of study (up to 53 months). Adverse events are reported from from the first dose to 30 days after the last dose or final cutoff on December 29, 2023, maximum treatment exposure was 232 weeks for Arm A and 157 weeks for Arm B.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
4.8%
11/227 • Number of events 11 • All-cause mortality is reported from randomization to the end of study (up to 53 months). Adverse events are reported from from the first dose to 30 days after the last dose or final cutoff on December 29, 2023, maximum treatment exposure was 232 weeks for Arm A and 157 weeks for Arm B.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
3.9%
9/229 • Number of events 17 • All-cause mortality is reported from randomization to the end of study (up to 53 months). Adverse events are reported from from the first dose to 30 days after the last dose or final cutoff on December 29, 2023, maximum treatment exposure was 232 weeks for Arm A and 157 weeks for Arm B.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
3.1%
7/227 • Number of events 7 • All-cause mortality is reported from randomization to the end of study (up to 53 months). Adverse events are reported from from the first dose to 30 days after the last dose or final cutoff on December 29, 2023, maximum treatment exposure was 232 weeks for Arm A and 157 weeks for Arm B.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
2.2%
5/229 • Number of events 5 • All-cause mortality is reported from randomization to the end of study (up to 53 months). Adverse events are reported from from the first dose to 30 days after the last dose or final cutoff on December 29, 2023, maximum treatment exposure was 232 weeks for Arm A and 157 weeks for Arm B.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
9.7%
22/227 • Number of events 24 • All-cause mortality is reported from randomization to the end of study (up to 53 months). Adverse events are reported from from the first dose to 30 days after the last dose or final cutoff on December 29, 2023, maximum treatment exposure was 232 weeks for Arm A and 157 weeks for Arm B.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
4.8%
11/229 • Number of events 13 • All-cause mortality is reported from randomization to the end of study (up to 53 months). Adverse events are reported from from the first dose to 30 days after the last dose or final cutoff on December 29, 2023, maximum treatment exposure was 232 weeks for Arm A and 157 weeks for Arm B.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
79.3%
180/227 • Number of events 182 • All-cause mortality is reported from randomization to the end of study (up to 53 months). Adverse events are reported from from the first dose to 30 days after the last dose or final cutoff on December 29, 2023, maximum treatment exposure was 232 weeks for Arm A and 157 weeks for Arm B.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
79.5%
182/229 • Number of events 185 • All-cause mortality is reported from randomization to the end of study (up to 53 months). Adverse events are reported from from the first dose to 30 days after the last dose or final cutoff on December 29, 2023, maximum treatment exposure was 232 weeks for Arm A and 157 weeks for Arm B.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
6.6%
15/227 • Number of events 18 • All-cause mortality is reported from randomization to the end of study (up to 53 months). Adverse events are reported from from the first dose to 30 days after the last dose or final cutoff on December 29, 2023, maximum treatment exposure was 232 weeks for Arm A and 157 weeks for Arm B.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
2.6%
6/229 • Number of events 8 • All-cause mortality is reported from randomization to the end of study (up to 53 months). Adverse events are reported from from the first dose to 30 days after the last dose or final cutoff on December 29, 2023, maximum treatment exposure was 232 weeks for Arm A and 157 weeks for Arm B.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
|
Skin and subcutaneous tissue disorders
Rash
|
14.5%
33/227 • Number of events 44 • All-cause mortality is reported from randomization to the end of study (up to 53 months). Adverse events are reported from from the first dose to 30 days after the last dose or final cutoff on December 29, 2023, maximum treatment exposure was 232 weeks for Arm A and 157 weeks for Arm B.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
8.7%
20/229 • Number of events 24 • All-cause mortality is reported from randomization to the end of study (up to 53 months). Adverse events are reported from from the first dose to 30 days after the last dose or final cutoff on December 29, 2023, maximum treatment exposure was 232 weeks for Arm A and 157 weeks for Arm B.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
|
Vascular disorders
Hypertension
|
9.3%
21/227 • Number of events 51 • All-cause mortality is reported from randomization to the end of study (up to 53 months). Adverse events are reported from from the first dose to 30 days after the last dose or final cutoff on December 29, 2023, maximum treatment exposure was 232 weeks for Arm A and 157 weeks for Arm B.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
7.9%
18/229 • Number of events 28 • All-cause mortality is reported from randomization to the end of study (up to 53 months). Adverse events are reported from from the first dose to 30 days after the last dose or final cutoff on December 29, 2023, maximum treatment exposure was 232 weeks for Arm A and 157 weeks for Arm B.
All-cause mortality is reported for all randomized participants. Serious and other adverse events includes all randomized participants who received ≥ 1 dose of any study treatment.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee BeiGene has 18 months from the end of the study at all sites to publish overall study results. After the 1st multi-site publication or the expiration of publication period, Investigators are free to publish/present the results of the study. Investigators must submit all draft publications/presentations to us for review 60 days prior to the planned publication/presentation date. BeiGene may request deletion of its confidential information \& may request a further delay to protect its IP rights.
- Publication restrictions are in place
Restriction type: OTHER