Trial Outcomes & Findings for A Study of Tislelizumab (BGB-A317) Versus Chemotherapy as Second Line Treatment in Participants With Advanced Esophageal Squamous Cell Carcinoma (NCT NCT03430843)
NCT ID: NCT03430843
Last Updated: 2024-10-26
Results Overview
OS is defined as the length of time from the date of randomization until the date of death due to any cause in all randomized participants
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
512 participants
Primary outcome timeframe
Approximately 2 years and 10 months from date of first randomization
Results posted on
2024-10-26
Participant Flow
This study was conducted at 132 study centers in Mainland China, Taiwan, United States, France, Italy, Germany, Spain, Japan, South Korea, Belgium and the United Kingdom.
Participant milestones
| Measure |
Tislelizumab
Tislelizumab 200 mg intravenously (IV) on Day 1 every 21 days until disease progression, unacceptable toxicity, or other discontinuation criteria were met.
|
Investigator Chosen Chemotherapy
Investigator choice of either paclitaxel 135-175 mg /m² on Day 1 IV every 21 days or 80-100 mg/m\^2 on a weekly schedule; docetaxel 75 mg/m\^2 IV on Day 1 every 21 days; or irinotecan 125 mg/m\^2 IV on Days 1 and 8 every 21 days
|
|---|---|---|
|
Overall Study
STARTED
|
256
|
256
|
|
Overall Study
Treated
|
255
|
240
|
|
Overall Study
COMPLETED
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
256
|
256
|
Reasons for withdrawal
| Measure |
Tislelizumab
Tislelizumab 200 mg intravenously (IV) on Day 1 every 21 days until disease progression, unacceptable toxicity, or other discontinuation criteria were met.
|
Investigator Chosen Chemotherapy
Investigator choice of either paclitaxel 135-175 mg /m² on Day 1 IV every 21 days or 80-100 mg/m\^2 on a weekly schedule; docetaxel 75 mg/m\^2 IV on Day 1 every 21 days; or irinotecan 125 mg/m\^2 IV on Days 1 and 8 every 21 days
|
|---|---|---|
|
Overall Study
Death
|
233
|
233
|
|
Overall Study
Sponsor Decision
|
17
|
6
|
|
Overall Study
Withdrawal by Subject
|
5
|
14
|
|
Overall Study
Lost to Follow-up
|
1
|
3
|
Baseline Characteristics
A Study of Tislelizumab (BGB-A317) Versus Chemotherapy as Second Line Treatment in Participants With Advanced Esophageal Squamous Cell Carcinoma
Baseline characteristics by cohort
| Measure |
Tislelizumab
n=256 Participants
Tislelizumab 200 mg intravenously (IV) on Day 1 every 21 days until disease progression, unacceptable toxicity, or other discontinuation criteria were met.
|
Investigator Chosen Chemotherapy
n=256 Participants
Investigator choice of either paclitaxel 135-175 mg /m² on Day 1 IV every 21 days or 80-100 mg/m\^2 on a weekly schedule; docetaxel 75 mg/m\^2 IV on Day 1 every 21 days; or irinotecan 125 mg/m\^2 IV on Days 1 and 8 every 21 days
|
Total
n=512 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
61.8 years
STANDARD_DEVIATION 8.41 • n=5 Participants
|
61.8 years
STANDARD_DEVIATION 8.02 • n=7 Participants
|
61.8 years
STANDARD_DEVIATION 8.21 • n=5 Participants
|
|
Sex: Female, Male
Female
|
39 Participants
n=5 Participants
|
41 Participants
n=7 Participants
|
80 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
217 Participants
n=5 Participants
|
215 Participants
n=7 Participants
|
432 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
252 Participants
n=5 Participants
|
252 Participants
n=7 Participants
|
504 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race · Asian
|
201 Participants
n=5 Participants
|
207 Participants
n=7 Participants
|
408 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race · White or Caucasian
|
53 Participants
n=5 Participants
|
44 Participants
n=7 Participants
|
97 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race · Not Reported
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race · Unknown
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race · Black or African American
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race · Other
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Eastern Cooperative Oncology Group (ECOG) Performance Status Score
0
|
66 Participants
n=5 Participants
|
61 Participants
n=7 Participants
|
127 Participants
n=5 Participants
|
|
Eastern Cooperative Oncology Group (ECOG) Performance Status Score
1
|
190 Participants
n=5 Participants
|
195 Participants
n=7 Participants
|
385 Participants
n=5 Participants
|
|
PD-L1 Expression Status
vCPS >= 10%
|
80 Participants
n=5 Participants
|
62 Participants
n=7 Participants
|
142 Participants
n=5 Participants
|
|
PD-L1 Expression Status
vCPS < 10%
|
100 Participants
n=5 Participants
|
122 Participants
n=7 Participants
|
222 Participants
n=5 Participants
|
|
PD-L1 Expression Status
Missing
|
76 Participants
n=5 Participants
|
72 Participants
n=7 Participants
|
148 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Approximately 2 years and 10 months from date of first randomizationPopulation: The ITT analysis set included all randomized participants
OS is defined as the length of time from the date of randomization until the date of death due to any cause in all randomized participants
Outcome measures
| Measure |
Tislelizumab
n=256 Participants
Tislelizumab 200 mg intravenously (IV) on Day 1 every 21 days until disease progression, unacceptable toxicity, or other discontinuation criteria were met.
|
Investigator Chosen Chemotherapy
n=256 Participants
Investigator choice of either paclitaxel 135-175 mg /m² on Day 1 IV every 21 days or 80-100 mg/m\^2 on a weekly schedule; docetaxel 75 mg/m\^2 IV on Day 1 every 21 days; or irinotecan 125 mg/m\^2 IV on Days 1 and 8 every 21 days
|
|---|---|---|
|
Overall Survival (OS) in the Intent-to-Treat (ITT) Analysis Set
|
8.6 Months
Interval 7.5 to 10.4
|
6.3 Months
Interval 5.3 to 7.0
|
SECONDARY outcome
Timeframe: Through End-of-Trial Analysis data cutoff date of 28-Dec-2022 (up to approximately 5 years)Population: The PD-L1 positive population included all randomized participants with tumor PD-L1 vCPS ≥10%
OS is defined as the time from the date of randomization until the date of death due to any cause in the PD-L1 positive population, defined as vCPS ≥10%.
Outcome measures
| Measure |
Tislelizumab
n=80 Participants
Tislelizumab 200 mg intravenously (IV) on Day 1 every 21 days until disease progression, unacceptable toxicity, or other discontinuation criteria were met.
|
Investigator Chosen Chemotherapy
n=62 Participants
Investigator choice of either paclitaxel 135-175 mg /m² on Day 1 IV every 21 days or 80-100 mg/m\^2 on a weekly schedule; docetaxel 75 mg/m\^2 IV on Day 1 every 21 days; or irinotecan 125 mg/m\^2 IV on Days 1 and 8 every 21 days
|
|---|---|---|
|
Overall Survival (OS) in the PDL-1 Positive Analysis Set
|
10.2 Months
Interval 8.5 to 14.5
|
5.1 Months
Interval 3.8 to 8.2
|
SECONDARY outcome
Timeframe: Through End-of-Trial Analysis data cutoff date of 28-Dec-2022 (up to approximately 5 years)Population: The ITT analysis set included all randomized participants
ORR is defined as the percentage of participants who had complete response (CR) or partial response (PR) as assessed by the investigator per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1;
Outcome measures
| Measure |
Tislelizumab
n=256 Participants
Tislelizumab 200 mg intravenously (IV) on Day 1 every 21 days until disease progression, unacceptable toxicity, or other discontinuation criteria were met.
|
Investigator Chosen Chemotherapy
n=256 Participants
Investigator choice of either paclitaxel 135-175 mg /m² on Day 1 IV every 21 days or 80-100 mg/m\^2 on a weekly schedule; docetaxel 75 mg/m\^2 IV on Day 1 every 21 days; or irinotecan 125 mg/m\^2 IV on Days 1 and 8 every 21 days
|
|---|---|---|
|
Objective Response Rate (ORR) in the ITT Analysis Set
|
20.3 Percentage of Participants
Interval 15.6 to 25.8
|
9.8 Percentage of Participants
Interval 6.4 to 14.1
|
SECONDARY outcome
Timeframe: Through End-of-Trial Analysis data cutoff date of 28-Dec-2022 (up to approximately 5 years)Population: The PD-L1 positive population is defined as a visually-estimated combined positive score (vCPS) ≥10%
ORR is defined as the percentage of participants who had complete response (CR) or partial response (PR) as assessed by the investigator per RECIST v1.1;
Outcome measures
| Measure |
Tislelizumab
n=80 Participants
Tislelizumab 200 mg intravenously (IV) on Day 1 every 21 days until disease progression, unacceptable toxicity, or other discontinuation criteria were met.
|
Investigator Chosen Chemotherapy
n=62 Participants
Investigator choice of either paclitaxel 135-175 mg /m² on Day 1 IV every 21 days or 80-100 mg/m\^2 on a weekly schedule; docetaxel 75 mg/m\^2 IV on Day 1 every 21 days; or irinotecan 125 mg/m\^2 IV on Days 1 and 8 every 21 days
|
|---|---|---|
|
Overall Response Rate (ORR) in the PD-L1 Positive Analysis Sets
|
26.3 Percentage of Participants
Interval 17.0 to 37.3
|
11.3 Percentage of Participants
Interval 4.7 to 21.9
|
SECONDARY outcome
Timeframe: Through End-of-Trial Analysis data cutoff date of 28-Dec-2022 (up to approximately 5 years)Population: The ITT analysis set included all randomized participants
PFS is defined as the time from the date of randomization to the date of first documentation of disease progression assessed by the investigator per RECIST v1.1 or death, whichever occurs first; reported for the ITT analysis set
Outcome measures
| Measure |
Tislelizumab
n=256 Participants
Tislelizumab 200 mg intravenously (IV) on Day 1 every 21 days until disease progression, unacceptable toxicity, or other discontinuation criteria were met.
|
Investigator Chosen Chemotherapy
n=256 Participants
Investigator choice of either paclitaxel 135-175 mg /m² on Day 1 IV every 21 days or 80-100 mg/m\^2 on a weekly schedule; docetaxel 75 mg/m\^2 IV on Day 1 every 21 days; or irinotecan 125 mg/m\^2 IV on Days 1 and 8 every 21 days
|
|---|---|---|
|
Progression-free Survival (PFS) in the ITT Analysis Set
|
1.6 Months
Interval 1.4 to 2.7
|
2.1 Months
Interval 1.5 to 2.7
|
SECONDARY outcome
Timeframe: Through End-of-Trial Analysis data cutoff date of 28-Dec-2022 (up to approximately 5 years)Population: The PD-L1 positive population is defined as a visually-estimated combined positive score (vCPS) ≥10%
PFS is defined as the time from the date of randomization to the date of first documentation of disease progression assessed by the investigator per RECIST v1.1 or death, whichever occurs first; reported for the PDL-1 Positive Analysis Set
Outcome measures
| Measure |
Tislelizumab
n=80 Participants
Tislelizumab 200 mg intravenously (IV) on Day 1 every 21 days until disease progression, unacceptable toxicity, or other discontinuation criteria were met.
|
Investigator Chosen Chemotherapy
n=62 Participants
Investigator choice of either paclitaxel 135-175 mg /m² on Day 1 IV every 21 days or 80-100 mg/m\^2 on a weekly schedule; docetaxel 75 mg/m\^2 IV on Day 1 every 21 days; or irinotecan 125 mg/m\^2 IV on Days 1 and 8 every 21 days
|
|---|---|---|
|
Progression-free Survival (PFS) in the PDL-1 Positive Analysis Set
|
2.7 Months
Interval 1.5 to 4.2
|
2.3 Months
Interval 1.4 to 3.0
|
SECONDARY outcome
Timeframe: Through End-of-Trial Analysis data cutoff date of 28-Dec-2022 (up to approximately 5 years)Population: The ITT analysis set included all randomized participants; only participants with an objective response (CR or PR) were included in this analysis
DOR is defined as the time from the first determination of an objective response until the first documentation of progression as assessed by the investigator per RECIST v1.1, or death, whichever comes first
Outcome measures
| Measure |
Tislelizumab
n=52 Participants
Tislelizumab 200 mg intravenously (IV) on Day 1 every 21 days until disease progression, unacceptable toxicity, or other discontinuation criteria were met.
|
Investigator Chosen Chemotherapy
n=25 Participants
Investigator choice of either paclitaxel 135-175 mg /m² on Day 1 IV every 21 days or 80-100 mg/m\^2 on a weekly schedule; docetaxel 75 mg/m\^2 IV on Day 1 every 21 days; or irinotecan 125 mg/m\^2 IV on Days 1 and 8 every 21 days
|
|---|---|---|
|
Duration of Response (DOR) in the ITT Analysis Set
|
7.1 Months
Interval 4.1 to 11.3
|
4.0 Months
Interval 2.1 to 8.2
|
SECONDARY outcome
Timeframe: Through End-of-Trial Analysis data cutoff date of 28-Dec-2022 (up to approximately 5 years)Population: The PD-L1 positive population is defined as a visually estimated combined positive score (vCPS) ≥10%; only participants with an objective response (CR or PR) were included in this analysis
DOR is defined as the time from the first determination of an objective response until the first documentation of progression as assessed by the investigator per RECIST v1.1, or death, whichever comes first
Outcome measures
| Measure |
Tislelizumab
n=21 Participants
Tislelizumab 200 mg intravenously (IV) on Day 1 every 21 days until disease progression, unacceptable toxicity, or other discontinuation criteria were met.
|
Investigator Chosen Chemotherapy
n=7 Participants
Investigator choice of either paclitaxel 135-175 mg /m² on Day 1 IV every 21 days or 80-100 mg/m\^2 on a weekly schedule; docetaxel 75 mg/m\^2 IV on Day 1 every 21 days; or irinotecan 125 mg/m\^2 IV on Days 1 and 8 every 21 days
|
|---|---|---|
|
Duration of Response (DOR) in the PDL-1 Positive Analysis Set.
|
7.1 Months
Interval 2.9 to 13.2
|
5.7 Months
Interval 1.2 to
Not estimable due to insufficient number of participants with events
|
SECONDARY outcome
Timeframe: Baseline to Cycle 6 (21 days per cycle)Population: The ITT analysis set included all randomized participants; "Overall number of participants analyzed" refers to number of participants evaluable for this outcome measure and "Number analyzed" refers to participants evaluable at the specified time point.
Mean change from baseline in EORTC QLQ-C30 index score. The EORTC QLQ-C30 v3.0 is a questionnaire that assesses quality of life of cancer participants. It includes global health status and quality of life questions related to overall health in which participants respond based on a 7-point scale, where 1 is very poor and 7 is excellent. Raw scores are transformed into a 0 to 100 scale via linear transformation. A higher score indicates better health outcomes
Outcome measures
| Measure |
Tislelizumab
n=239 Participants
Tislelizumab 200 mg intravenously (IV) on Day 1 every 21 days until disease progression, unacceptable toxicity, or other discontinuation criteria were met.
|
Investigator Chosen Chemotherapy
n=246 Participants
Investigator choice of either paclitaxel 135-175 mg /m² on Day 1 IV every 21 days or 80-100 mg/m\^2 on a weekly schedule; docetaxel 75 mg/m\^2 IV on Day 1 every 21 days; or irinotecan 125 mg/m\^2 IV on Days 1 and 8 every 21 days
|
|---|---|---|
|
Health-Related Quality of Life (HRQoL) as Assessed by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C-30) in the ITT Analysis Set
Baseline
|
16.2 Score on a scale
Standard Deviation 12.28
|
18.3 Score on a scale
Standard Deviation 13.86
|
|
Health-Related Quality of Life (HRQoL) as Assessed by European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C-30) in the ITT Analysis Set
Change at Cycle 6
|
0.2 Score on a scale
Standard Deviation 8.28
|
4.8 Score on a scale
Standard Deviation 9.38
|
SECONDARY outcome
Timeframe: Baseline to Cycle 6 (21 days per cycle)Population: The PD-L1 positive population is defined as a visually estimated combined positive score (vCPS) ≥10%; "Overall number of participants analyzed" refers to number of participants evaluable for this outcome measure and "Number analyzed" refers to participants evaluable at the specified time point.
Mean change from baseline in EORTC QLQ-C30 Index score. The EORTC QLQ-C30 v3.0 is a questionnaire that assesses quality of life of cancer participants. It includes global health status and quality of life questions related to overall health in which participants respond based on a 7-point scale, where 1 is very poor and 7 is excellent. Raw scores are transformed into a 0 to 100 scale via linear transformation. A higher score indicates better health outcomes
Outcome measures
| Measure |
Tislelizumab
n=77 Participants
Tislelizumab 200 mg intravenously (IV) on Day 1 every 21 days until disease progression, unacceptable toxicity, or other discontinuation criteria were met.
|
Investigator Chosen Chemotherapy
n=59 Participants
Investigator choice of either paclitaxel 135-175 mg /m² on Day 1 IV every 21 days or 80-100 mg/m\^2 on a weekly schedule; docetaxel 75 mg/m\^2 IV on Day 1 every 21 days; or irinotecan 125 mg/m\^2 IV on Days 1 and 8 every 21 days
|
|---|---|---|
|
HRQoL as Assessed by EORTC QLQ-C30 in the PDL-1 Positive Analysis Set
Baseline
|
16.8 Score on a scale
Standard Deviation 10.96
|
18.8 Score on a scale
Standard Deviation 12.02
|
|
HRQoL as Assessed by EORTC QLQ-C30 in the PDL-1 Positive Analysis Set
Change at Cycle 6
|
0.5 Score on a scale
Standard Deviation 7.39
|
0.5 Score on a scale
Standard Deviation 4.86
|
SECONDARY outcome
Timeframe: Baseline to Cycle 6 (21 days per cycle)Population: The ITT analysis set included all randomized participants; "Overall number of participants analyzed" refers to number of participants evaluable for this outcome measure and "Number analyzed" refers to participants evaluable at the specified time point.
Mean change from baseline in EORTC QLQ-OES18 index score. The EORTC QLQ-OES18 is a questionnaire that assesses overall symptoms in esophageal cancer participants. It includes questions related to overall health in which participants respond based on a 7-point scale, where 1 is very poor and 7 is excellent. Raw scores are transformed into a 0 to 100 scale via linear transformation. A higher score indicates better health outcomes.
Outcome measures
| Measure |
Tislelizumab
n=239 Participants
Tislelizumab 200 mg intravenously (IV) on Day 1 every 21 days until disease progression, unacceptable toxicity, or other discontinuation criteria were met.
|
Investigator Chosen Chemotherapy
n=246 Participants
Investigator choice of either paclitaxel 135-175 mg /m² on Day 1 IV every 21 days or 80-100 mg/m\^2 on a weekly schedule; docetaxel 75 mg/m\^2 IV on Day 1 every 21 days; or irinotecan 125 mg/m\^2 IV on Days 1 and 8 every 21 days
|
|---|---|---|
|
HRQoL as Assessed by EORTC QLQ-Oesophagus Cancer Module (EORTC QLQ-OES18) Reported in ITT Analysis Set
Baseline
|
14.7 Score on a scale
Standard Deviation 11.81
|
16.3 Score on a scale
Standard Deviation 13.20
|
|
HRQoL as Assessed by EORTC QLQ-Oesophagus Cancer Module (EORTC QLQ-OES18) Reported in ITT Analysis Set
Change at Cycle 6
|
-0.6 Score on a scale
Standard Deviation 8.63
|
3.0 Score on a scale
Standard Deviation 12.05
|
SECONDARY outcome
Timeframe: Baseline to Cycle 6 (21 days per cycle)Population: The PD-L1 positive population is defined as a visually-estimated combined positive score (vCPS) ≥10%; "Overall number of participants analyzed" refers to number of participants evaluable for this outcome measure and "Number analyzed" refers to participants evaluable at the specified time point.
Mean change from baseline in EORTC QLQ-OES18 index score. The EORTC QLQ-OES18 is a questionnaire that assesses overall symptoms in esophageal cancer participants. It includes questions related to overall health in which participants respond based on a 7-point scale, where 1 is very poor and 7 is excellent. Raw scores are transformed into a 0 to 100 scale via linear transformation. A higher score indicates better health outcomes.
Outcome measures
| Measure |
Tislelizumab
n=76 Participants
Tislelizumab 200 mg intravenously (IV) on Day 1 every 21 days until disease progression, unacceptable toxicity, or other discontinuation criteria were met.
|
Investigator Chosen Chemotherapy
n=59 Participants
Investigator choice of either paclitaxel 135-175 mg /m² on Day 1 IV every 21 days or 80-100 mg/m\^2 on a weekly schedule; docetaxel 75 mg/m\^2 IV on Day 1 every 21 days; or irinotecan 125 mg/m\^2 IV on Days 1 and 8 every 21 days
|
|---|---|---|
|
HRQoL as Assessed by EORTC QLQ-OES18) in the PDL-1 Positive Analysis Set.
Baseline
|
16.5 Score on a scale
Standard Deviation 12.69
|
18.1 Score on a scale
Standard Deviation 12.21
|
|
HRQoL as Assessed by EORTC QLQ-OES18) in the PDL-1 Positive Analysis Set.
Change at Cycle 6
|
-0.9 Score on a scale
Standard Deviation 7.45
|
-2.9 Score on a scale
Standard Deviation 5.16
|
SECONDARY outcome
Timeframe: Baseline to Cycle 6 (21 days per cycle)Population: The ITT analysis set included all randomized participants; "Overall number of participants analyzed" refers to number of participants evaluable for this outcome measure and "Number analyzed" refers to participants evaluable at the specified time point.
Mean change from baseline in EQ-5D-5L visual acuity score (VAS). The EQ-5D-5L measures health outcomes using a VAS to record a participant's self-rated health on a scale from 0 to 100, where 100 is 'the best health you can imagine' and 0 is 'the worst health you can imagine.' A higher score indicates better health outcomes.
Outcome measures
| Measure |
Tislelizumab
n=242 Participants
Tislelizumab 200 mg intravenously (IV) on Day 1 every 21 days until disease progression, unacceptable toxicity, or other discontinuation criteria were met.
|
Investigator Chosen Chemotherapy
n=247 Participants
Investigator choice of either paclitaxel 135-175 mg /m² on Day 1 IV every 21 days or 80-100 mg/m\^2 on a weekly schedule; docetaxel 75 mg/m\^2 IV on Day 1 every 21 days; or irinotecan 125 mg/m\^2 IV on Days 1 and 8 every 21 days
|
|---|---|---|
|
HRQoL as Assessed by European Quality of Life 5-Dimensions 5-Level Questionnaire (EQ-5D-5L) in the ITT Analysis Set
Baseline
|
73.7 Score on a scale
Standard Deviation 17.05
|
72.5 Score on a scale
Standard Deviation 18.13
|
|
HRQoL as Assessed by European Quality of Life 5-Dimensions 5-Level Questionnaire (EQ-5D-5L) in the ITT Analysis Set
Change at Cycle 6
|
-0.6 Score on a scale
Standard Deviation 14.81
|
-5.9 Score on a scale
Standard Deviation 16.34
|
SECONDARY outcome
Timeframe: Baseline to Cycle 6 (21 days per cycle)Population: The PD-L1 positive population is defined as a visually-estimated combined positive score (vCPS) ≥10%; "Overall number of participants analyzed" refers to number of participants evaluable for this outcome measure and "Number analyzed" refers to participants evaluable at the specified time point
Mean change from baseline in EQ-5D-5L visual acuity score (VAS). The EQ-5D-5L measures health outcomes using a VAS to record a participant's self-rated health on a scale from 0 to 100, where 100 is 'the best health you can imagine' and 0 is 'the worst health you can imagine.' A higher score indicates better health outcomes.
Outcome measures
| Measure |
Tislelizumab
n=78 Participants
Tislelizumab 200 mg intravenously (IV) on Day 1 every 21 days until disease progression, unacceptable toxicity, or other discontinuation criteria were met.
|
Investigator Chosen Chemotherapy
n=59 Participants
Investigator choice of either paclitaxel 135-175 mg /m² on Day 1 IV every 21 days or 80-100 mg/m\^2 on a weekly schedule; docetaxel 75 mg/m\^2 IV on Day 1 every 21 days; or irinotecan 125 mg/m\^2 IV on Days 1 and 8 every 21 days
|
|---|---|---|
|
HRQoL as Assessed by EQ-5D-5L in the PD-L1 Positive Analysis Set
Baseline
|
74.1 Score on a scale
Standard Deviation 14.84
|
70.5 Score on a scale
Standard Deviation 18.40
|
|
HRQoL as Assessed by EQ-5D-5L in the PD-L1 Positive Analysis Set
Change at Cycle 6
|
-0.5 Score on a scale
Standard Deviation 17.59
|
4.4 Score on a scale
Standard Deviation 12.82
|
SECONDARY outcome
Timeframe: From the first dose date to 30 days after the last dose date; up to approximately 4 years and 11 monthsPopulation: Safety analysis set included all participants who received ≥ 1 dose of study drug
Number of participants with treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs), which includes laboratory tests, physical exams, electrocardiogram results and vital signs
Outcome measures
| Measure |
Tislelizumab
n=255 Participants
Tislelizumab 200 mg intravenously (IV) on Day 1 every 21 days until disease progression, unacceptable toxicity, or other discontinuation criteria were met.
|
Investigator Chosen Chemotherapy
n=240 Participants
Investigator choice of either paclitaxel 135-175 mg /m² on Day 1 IV every 21 days or 80-100 mg/m\^2 on a weekly schedule; docetaxel 75 mg/m\^2 IV on Day 1 every 21 days; or irinotecan 125 mg/m\^2 IV on Days 1 and 8 every 21 days
|
|---|---|---|
|
Number of Participants Experiencing Adverse Events (AEs)
Number of participants with TEAEs
|
245 Participants
|
236 Participants
|
|
Number of Participants Experiencing Adverse Events (AEs)
Number of participants with SAEs
|
109 Participants
|
106 Participants
|
Adverse Events
Tislelizumab
Serious events: 109 serious events
Other events: 232 other events
Deaths: 233 deaths
Investigator Chosen Chemotherapy (ICC)
Serious events: 106 serious events
Other events: 231 other events
Deaths: 233 deaths
Serious adverse events
| Measure |
Tislelizumab
n=255 participants at risk
Tislelizumab 200 mg intravenously (IV) on Day 1 every 21 days until disease progression, unacceptable toxicity, or other discontinuation criteria were met.
|
Investigator Chosen Chemotherapy (ICC)
n=240 participants at risk
Investigator choice of either paclitaxel 135-175 mg /m² on Day 1 IV every 21 days or 80-100 mg/m\^2 on a weekly schedule; docetaxel 75 mg/m\^2 IV on Day 1 every 21 days; or irinotecan 125 mg/m\^2 IV on Days 1 and 8 every 21 days
|
|---|---|---|
|
Gastrointestinal disorders
Oesophageal fistula
|
0.78%
2/255 • Number of events 2 • All-cause mortality and adverse events (AEs): up to approximately 4 years and 11 months
All-cause mortality is reported for all randomized participants; Serious and other AEs include participants who received at least one dose of study drug. AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
0.42%
1/240 • Number of events 1 • All-cause mortality and adverse events (AEs): up to approximately 4 years and 11 months
All-cause mortality is reported for all randomized participants; Serious and other AEs include participants who received at least one dose of study drug. AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
|
Blood and lymphatic system disorders
Agranulocytosis
|
0.00%
0/255 • All-cause mortality and adverse events (AEs): up to approximately 4 years and 11 months
All-cause mortality is reported for all randomized participants; Serious and other AEs include participants who received at least one dose of study drug. AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
0.42%
1/240 • Number of events 1 • All-cause mortality and adverse events (AEs): up to approximately 4 years and 11 months
All-cause mortality is reported for all randomized participants; Serious and other AEs include participants who received at least one dose of study drug. AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
|
Blood and lymphatic system disorders
Anaemia
|
0.39%
1/255 • Number of events 1 • All-cause mortality and adverse events (AEs): up to approximately 4 years and 11 months
All-cause mortality is reported for all randomized participants; Serious and other AEs include participants who received at least one dose of study drug. AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
1.2%
3/240 • Number of events 9 • All-cause mortality and adverse events (AEs): up to approximately 4 years and 11 months
All-cause mortality is reported for all randomized participants; Serious and other AEs include participants who received at least one dose of study drug. AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
0.00%
0/255 • All-cause mortality and adverse events (AEs): up to approximately 4 years and 11 months
All-cause mortality is reported for all randomized participants; Serious and other AEs include participants who received at least one dose of study drug. AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
3.3%
8/240 • Number of events 9 • All-cause mortality and adverse events (AEs): up to approximately 4 years and 11 months
All-cause mortality is reported for all randomized participants; Serious and other AEs include participants who received at least one dose of study drug. AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
|
Blood and lymphatic system disorders
Iron deficiency anaemia
|
0.00%
0/255 • All-cause mortality and adverse events (AEs): up to approximately 4 years and 11 months
All-cause mortality is reported for all randomized participants; Serious and other AEs include participants who received at least one dose of study drug. AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
0.42%
1/240 • Number of events 1 • All-cause mortality and adverse events (AEs): up to approximately 4 years and 11 months
All-cause mortality is reported for all randomized participants; Serious and other AEs include participants who received at least one dose of study drug. AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
|
Blood and lymphatic system disorders
Leukopenia
|
0.00%
0/255 • All-cause mortality and adverse events (AEs): up to approximately 4 years and 11 months
All-cause mortality is reported for all randomized participants; Serious and other AEs include participants who received at least one dose of study drug. AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
1.7%
4/240 • Number of events 7 • All-cause mortality and adverse events (AEs): up to approximately 4 years and 11 months
All-cause mortality is reported for all randomized participants; Serious and other AEs include participants who received at least one dose of study drug. AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
|
Blood and lymphatic system disorders
Myelosuppression
|
0.00%
0/255 • All-cause mortality and adverse events (AEs): up to approximately 4 years and 11 months
All-cause mortality is reported for all randomized participants; Serious and other AEs include participants who received at least one dose of study drug. AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
0.42%
1/240 • Number of events 1 • All-cause mortality and adverse events (AEs): up to approximately 4 years and 11 months
All-cause mortality is reported for all randomized participants; Serious and other AEs include participants who received at least one dose of study drug. AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.00%
0/255 • All-cause mortality and adverse events (AEs): up to approximately 4 years and 11 months
All-cause mortality is reported for all randomized participants; Serious and other AEs include participants who received at least one dose of study drug. AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
0.83%
2/240 • Number of events 4 • All-cause mortality and adverse events (AEs): up to approximately 4 years and 11 months
All-cause mortality is reported for all randomized participants; Serious and other AEs include participants who received at least one dose of study drug. AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/255 • All-cause mortality and adverse events (AEs): up to approximately 4 years and 11 months
All-cause mortality is reported for all randomized participants; Serious and other AEs include participants who received at least one dose of study drug. AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
0.42%
1/240 • Number of events 1 • All-cause mortality and adverse events (AEs): up to approximately 4 years and 11 months
All-cause mortality is reported for all randomized participants; Serious and other AEs include participants who received at least one dose of study drug. AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
|
Cardiac disorders
Acute left ventricular failure
|
0.00%
0/255 • All-cause mortality and adverse events (AEs): up to approximately 4 years and 11 months
All-cause mortality is reported for all randomized participants; Serious and other AEs include participants who received at least one dose of study drug. AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
0.42%
1/240 • Number of events 1 • All-cause mortality and adverse events (AEs): up to approximately 4 years and 11 months
All-cause mortality is reported for all randomized participants; Serious and other AEs include participants who received at least one dose of study drug. AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
|
Cardiac disorders
Autoimmune myocarditis
|
0.39%
1/255 • Number of events 1 • All-cause mortality and adverse events (AEs): up to approximately 4 years and 11 months
All-cause mortality is reported for all randomized participants; Serious and other AEs include participants who received at least one dose of study drug. AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
0.00%
0/240 • All-cause mortality and adverse events (AEs): up to approximately 4 years and 11 months
All-cause mortality is reported for all randomized participants; Serious and other AEs include participants who received at least one dose of study drug. AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
|
Cardiac disorders
Cardiac arrest
|
0.00%
0/255 • All-cause mortality and adverse events (AEs): up to approximately 4 years and 11 months
All-cause mortality is reported for all randomized participants; Serious and other AEs include participants who received at least one dose of study drug. AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
0.42%
1/240 • Number of events 1 • All-cause mortality and adverse events (AEs): up to approximately 4 years and 11 months
All-cause mortality is reported for all randomized participants; Serious and other AEs include participants who received at least one dose of study drug. AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
|
Cardiac disorders
Cardio-respiratory arrest
|
0.39%
1/255 • Number of events 1 • All-cause mortality and adverse events (AEs): up to approximately 4 years and 11 months
All-cause mortality is reported for all randomized participants; Serious and other AEs include participants who received at least one dose of study drug. AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
0.00%
0/240 • All-cause mortality and adverse events (AEs): up to approximately 4 years and 11 months
All-cause mortality is reported for all randomized participants; Serious and other AEs include participants who received at least one dose of study drug. AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
|
Cardiac disorders
Immune-mediated myocarditis
|
0.39%
1/255 • Number of events 1 • All-cause mortality and adverse events (AEs): up to approximately 4 years and 11 months
All-cause mortality is reported for all randomized participants; Serious and other AEs include participants who received at least one dose of study drug. AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
0.00%
0/240 • All-cause mortality and adverse events (AEs): up to approximately 4 years and 11 months
All-cause mortality is reported for all randomized participants; Serious and other AEs include participants who received at least one dose of study drug. AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
|
Cardiac disorders
Myocardial infarction
|
0.00%
0/255 • All-cause mortality and adverse events (AEs): up to approximately 4 years and 11 months
All-cause mortality is reported for all randomized participants; Serious and other AEs include participants who received at least one dose of study drug. AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
0.42%
1/240 • Number of events 1 • All-cause mortality and adverse events (AEs): up to approximately 4 years and 11 months
All-cause mortality is reported for all randomized participants; Serious and other AEs include participants who received at least one dose of study drug. AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
|
Cardiac disorders
Pericardial effusion
|
0.39%
1/255 • Number of events 1 • All-cause mortality and adverse events (AEs): up to approximately 4 years and 11 months
All-cause mortality is reported for all randomized participants; Serious and other AEs include participants who received at least one dose of study drug. AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
0.00%
0/240 • All-cause mortality and adverse events (AEs): up to approximately 4 years and 11 months
All-cause mortality is reported for all randomized participants; Serious and other AEs include participants who received at least one dose of study drug. AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
|
Cardiac disorders
Supraventricular tachycardia
|
0.39%
1/255 • Number of events 1 • All-cause mortality and adverse events (AEs): up to approximately 4 years and 11 months
All-cause mortality is reported for all randomized participants; Serious and other AEs include participants who received at least one dose of study drug. AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
0.00%
0/240 • All-cause mortality and adverse events (AEs): up to approximately 4 years and 11 months
All-cause mortality is reported for all randomized participants; Serious and other AEs include participants who received at least one dose of study drug. AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
|
Endocrine disorders
Adrenocorticotropic hormone deficiency
|
0.39%
1/255 • Number of events 1 • All-cause mortality and adverse events (AEs): up to approximately 4 years and 11 months
All-cause mortality is reported for all randomized participants; Serious and other AEs include participants who received at least one dose of study drug. AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
0.00%
0/240 • All-cause mortality and adverse events (AEs): up to approximately 4 years and 11 months
All-cause mortality is reported for all randomized participants; Serious and other AEs include participants who received at least one dose of study drug. AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
|
Endocrine disorders
Hypothyroidism
|
0.39%
1/255 • Number of events 1 • All-cause mortality and adverse events (AEs): up to approximately 4 years and 11 months
All-cause mortality is reported for all randomized participants; Serious and other AEs include participants who received at least one dose of study drug. AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
0.00%
0/240 • All-cause mortality and adverse events (AEs): up to approximately 4 years and 11 months
All-cause mortality is reported for all randomized participants; Serious and other AEs include participants who received at least one dose of study drug. AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
|
Gastrointestinal disorders
Abdominal distension
|
0.39%
1/255 • Number of events 1 • All-cause mortality and adverse events (AEs): up to approximately 4 years and 11 months
All-cause mortality is reported for all randomized participants; Serious and other AEs include participants who received at least one dose of study drug. AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
0.00%
0/240 • All-cause mortality and adverse events (AEs): up to approximately 4 years and 11 months
All-cause mortality is reported for all randomized participants; Serious and other AEs include participants who received at least one dose of study drug. AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.39%
1/255 • Number of events 1 • All-cause mortality and adverse events (AEs): up to approximately 4 years and 11 months
All-cause mortality is reported for all randomized participants; Serious and other AEs include participants who received at least one dose of study drug. AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
0.42%
1/240 • Number of events 1 • All-cause mortality and adverse events (AEs): up to approximately 4 years and 11 months
All-cause mortality is reported for all randomized participants; Serious and other AEs include participants who received at least one dose of study drug. AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
|
Gastrointestinal disorders
Anal fistula
|
0.39%
1/255 • Number of events 1 • All-cause mortality and adverse events (AEs): up to approximately 4 years and 11 months
All-cause mortality is reported for all randomized participants; Serious and other AEs include participants who received at least one dose of study drug. AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
0.00%
0/240 • All-cause mortality and adverse events (AEs): up to approximately 4 years and 11 months
All-cause mortality is reported for all randomized participants; Serious and other AEs include participants who received at least one dose of study drug. AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
|
Gastrointestinal disorders
Colitis
|
0.39%
1/255 • Number of events 1 • All-cause mortality and adverse events (AEs): up to approximately 4 years and 11 months
All-cause mortality is reported for all randomized participants; Serious and other AEs include participants who received at least one dose of study drug. AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
0.42%
1/240 • Number of events 1 • All-cause mortality and adverse events (AEs): up to approximately 4 years and 11 months
All-cause mortality is reported for all randomized participants; Serious and other AEs include participants who received at least one dose of study drug. AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/255 • All-cause mortality and adverse events (AEs): up to approximately 4 years and 11 months
All-cause mortality is reported for all randomized participants; Serious and other AEs include participants who received at least one dose of study drug. AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
0.42%
1/240 • Number of events 1 • All-cause mortality and adverse events (AEs): up to approximately 4 years and 11 months
All-cause mortality is reported for all randomized participants; Serious and other AEs include participants who received at least one dose of study drug. AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/255 • All-cause mortality and adverse events (AEs): up to approximately 4 years and 11 months
All-cause mortality is reported for all randomized participants; Serious and other AEs include participants who received at least one dose of study drug. AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
3.3%
8/240 • Number of events 8 • All-cause mortality and adverse events (AEs): up to approximately 4 years and 11 months
All-cause mortality is reported for all randomized participants; Serious and other AEs include participants who received at least one dose of study drug. AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
|
Gastrointestinal disorders
Dysphagia
|
5.1%
13/255 • Number of events 16 • All-cause mortality and adverse events (AEs): up to approximately 4 years and 11 months
All-cause mortality is reported for all randomized participants; Serious and other AEs include participants who received at least one dose of study drug. AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
1.7%
4/240 • Number of events 5 • All-cause mortality and adverse events (AEs): up to approximately 4 years and 11 months
All-cause mortality is reported for all randomized participants; Serious and other AEs include participants who received at least one dose of study drug. AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
|
Gastrointestinal disorders
Gastric fistula
|
0.00%
0/255 • All-cause mortality and adverse events (AEs): up to approximately 4 years and 11 months
All-cause mortality is reported for all randomized participants; Serious and other AEs include participants who received at least one dose of study drug. AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
0.42%
1/240 • Number of events 2 • All-cause mortality and adverse events (AEs): up to approximately 4 years and 11 months
All-cause mortality is reported for all randomized participants; Serious and other AEs include participants who received at least one dose of study drug. AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
|
Gastrointestinal disorders
Gastric haemorrhage
|
0.39%
1/255 • Number of events 1 • All-cause mortality and adverse events (AEs): up to approximately 4 years and 11 months
All-cause mortality is reported for all randomized participants; Serious and other AEs include participants who received at least one dose of study drug. AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
0.00%
0/240 • All-cause mortality and adverse events (AEs): up to approximately 4 years and 11 months
All-cause mortality is reported for all randomized participants; Serious and other AEs include participants who received at least one dose of study drug. AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
|
Gastrointestinal disorders
Gastrointestinal disorder
|
0.00%
0/255 • All-cause mortality and adverse events (AEs): up to approximately 4 years and 11 months
All-cause mortality is reported for all randomized participants; Serious and other AEs include participants who received at least one dose of study drug. AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
0.83%
2/240 • Number of events 4 • All-cause mortality and adverse events (AEs): up to approximately 4 years and 11 months
All-cause mortality is reported for all randomized participants; Serious and other AEs include participants who received at least one dose of study drug. AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.39%
1/255 • Number of events 1 • All-cause mortality and adverse events (AEs): up to approximately 4 years and 11 months
All-cause mortality is reported for all randomized participants; Serious and other AEs include participants who received at least one dose of study drug. AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
0.42%
1/240 • Number of events 1 • All-cause mortality and adverse events (AEs): up to approximately 4 years and 11 months
All-cause mortality is reported for all randomized participants; Serious and other AEs include participants who received at least one dose of study drug. AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
|
Gastrointestinal disorders
Intestinal ischaemia
|
0.00%
0/255 • All-cause mortality and adverse events (AEs): up to approximately 4 years and 11 months
All-cause mortality is reported for all randomized participants; Serious and other AEs include participants who received at least one dose of study drug. AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
0.42%
1/240 • Number of events 1 • All-cause mortality and adverse events (AEs): up to approximately 4 years and 11 months
All-cause mortality is reported for all randomized participants; Serious and other AEs include participants who received at least one dose of study drug. AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
|
Gastrointestinal disorders
Intestinal obstruction
|
0.00%
0/255 • All-cause mortality and adverse events (AEs): up to approximately 4 years and 11 months
All-cause mortality is reported for all randomized participants; Serious and other AEs include participants who received at least one dose of study drug. AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
0.42%
1/240 • Number of events 1 • All-cause mortality and adverse events (AEs): up to approximately 4 years and 11 months
All-cause mortality is reported for all randomized participants; Serious and other AEs include participants who received at least one dose of study drug. AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
|
Gastrointestinal disorders
Melaena
|
0.00%
0/255 • All-cause mortality and adverse events (AEs): up to approximately 4 years and 11 months
All-cause mortality is reported for all randomized participants; Serious and other AEs include participants who received at least one dose of study drug. AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
0.42%
1/240 • Number of events 1 • All-cause mortality and adverse events (AEs): up to approximately 4 years and 11 months
All-cause mortality is reported for all randomized participants; Serious and other AEs include participants who received at least one dose of study drug. AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/255 • All-cause mortality and adverse events (AEs): up to approximately 4 years and 11 months
All-cause mortality is reported for all randomized participants; Serious and other AEs include participants who received at least one dose of study drug. AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
1.7%
4/240 • Number of events 6 • All-cause mortality and adverse events (AEs): up to approximately 4 years and 11 months
All-cause mortality is reported for all randomized participants; Serious and other AEs include participants who received at least one dose of study drug. AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
|
Gastrointestinal disorders
Odynophagia
|
0.39%
1/255 • Number of events 1 • All-cause mortality and adverse events (AEs): up to approximately 4 years and 11 months
All-cause mortality is reported for all randomized participants; Serious and other AEs include participants who received at least one dose of study drug. AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
0.00%
0/240 • All-cause mortality and adverse events (AEs): up to approximately 4 years and 11 months
All-cause mortality is reported for all randomized participants; Serious and other AEs include participants who received at least one dose of study drug. AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
|
Gastrointestinal disorders
Oesophageal haemorrhage
|
0.00%
0/255 • All-cause mortality and adverse events (AEs): up to approximately 4 years and 11 months
All-cause mortality is reported for all randomized participants; Serious and other AEs include participants who received at least one dose of study drug. AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
0.42%
1/240 • Number of events 1 • All-cause mortality and adverse events (AEs): up to approximately 4 years and 11 months
All-cause mortality is reported for all randomized participants; Serious and other AEs include participants who received at least one dose of study drug. AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
|
Gastrointestinal disorders
Oesophageal obstruction
|
2.0%
5/255 • Number of events 6 • All-cause mortality and adverse events (AEs): up to approximately 4 years and 11 months
All-cause mortality is reported for all randomized participants; Serious and other AEs include participants who received at least one dose of study drug. AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
0.42%
1/240 • Number of events 1 • All-cause mortality and adverse events (AEs): up to approximately 4 years and 11 months
All-cause mortality is reported for all randomized participants; Serious and other AEs include participants who received at least one dose of study drug. AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
|
Gastrointestinal disorders
Oesophageal stenosis
|
1.2%
3/255 • Number of events 4 • All-cause mortality and adverse events (AEs): up to approximately 4 years and 11 months
All-cause mortality is reported for all randomized participants; Serious and other AEs include participants who received at least one dose of study drug. AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
0.00%
0/240 • All-cause mortality and adverse events (AEs): up to approximately 4 years and 11 months
All-cause mortality is reported for all randomized participants; Serious and other AEs include participants who received at least one dose of study drug. AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
|
Gastrointestinal disorders
Oesophagitis
|
0.39%
1/255 • Number of events 1 • All-cause mortality and adverse events (AEs): up to approximately 4 years and 11 months
All-cause mortality is reported for all randomized participants; Serious and other AEs include participants who received at least one dose of study drug. AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
0.00%
0/240 • All-cause mortality and adverse events (AEs): up to approximately 4 years and 11 months
All-cause mortality is reported for all randomized participants; Serious and other AEs include participants who received at least one dose of study drug. AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
|
Gastrointestinal disorders
Oesophagomediastinal fistula
|
0.78%
2/255 • Number of events 2 • All-cause mortality and adverse events (AEs): up to approximately 4 years and 11 months
All-cause mortality is reported for all randomized participants; Serious and other AEs include participants who received at least one dose of study drug. AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
0.00%
0/240 • All-cause mortality and adverse events (AEs): up to approximately 4 years and 11 months
All-cause mortality is reported for all randomized participants; Serious and other AEs include participants who received at least one dose of study drug. AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
|
Gastrointestinal disorders
Rectal obstruction
|
0.39%
1/255 • Number of events 1 • All-cause mortality and adverse events (AEs): up to approximately 4 years and 11 months
All-cause mortality is reported for all randomized participants; Serious and other AEs include participants who received at least one dose of study drug. AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
0.00%
0/240 • All-cause mortality and adverse events (AEs): up to approximately 4 years and 11 months
All-cause mortality is reported for all randomized participants; Serious and other AEs include participants who received at least one dose of study drug. AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
|
Gastrointestinal disorders
Reflux gastritis
|
0.39%
1/255 • Number of events 1 • All-cause mortality and adverse events (AEs): up to approximately 4 years and 11 months
All-cause mortality is reported for all randomized participants; Serious and other AEs include participants who received at least one dose of study drug. AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
0.00%
0/240 • All-cause mortality and adverse events (AEs): up to approximately 4 years and 11 months
All-cause mortality is reported for all randomized participants; Serious and other AEs include participants who received at least one dose of study drug. AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
|
Gastrointestinal disorders
Stomatitis
|
0.00%
0/255 • All-cause mortality and adverse events (AEs): up to approximately 4 years and 11 months
All-cause mortality is reported for all randomized participants; Serious and other AEs include participants who received at least one dose of study drug. AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
0.42%
1/240 • Number of events 1 • All-cause mortality and adverse events (AEs): up to approximately 4 years and 11 months
All-cause mortality is reported for all randomized participants; Serious and other AEs include participants who received at least one dose of study drug. AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
|
Gastrointestinal disorders
Upper gastrointestinal haemorrhage
|
1.6%
4/255 • Number of events 4 • All-cause mortality and adverse events (AEs): up to approximately 4 years and 11 months
All-cause mortality is reported for all randomized participants; Serious and other AEs include participants who received at least one dose of study drug. AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
1.7%
4/240 • Number of events 4 • All-cause mortality and adverse events (AEs): up to approximately 4 years and 11 months
All-cause mortality is reported for all randomized participants; Serious and other AEs include participants who received at least one dose of study drug. AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
|
Gastrointestinal disorders
Vomiting
|
0.78%
2/255 • Number of events 2 • All-cause mortality and adverse events (AEs): up to approximately 4 years and 11 months
All-cause mortality is reported for all randomized participants; Serious and other AEs include participants who received at least one dose of study drug. AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
1.2%
3/240 • Number of events 3 • All-cause mortality and adverse events (AEs): up to approximately 4 years and 11 months
All-cause mortality is reported for all randomized participants; Serious and other AEs include participants who received at least one dose of study drug. AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
|
General disorders
Asthenia
|
0.00%
0/255 • All-cause mortality and adverse events (AEs): up to approximately 4 years and 11 months
All-cause mortality is reported for all randomized participants; Serious and other AEs include participants who received at least one dose of study drug. AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
0.42%
1/240 • Number of events 1 • All-cause mortality and adverse events (AEs): up to approximately 4 years and 11 months
All-cause mortality is reported for all randomized participants; Serious and other AEs include participants who received at least one dose of study drug. AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
|
General disorders
Death
|
0.78%
2/255 • Number of events 2 • All-cause mortality and adverse events (AEs): up to approximately 4 years and 11 months
All-cause mortality is reported for all randomized participants; Serious and other AEs include participants who received at least one dose of study drug. AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
1.7%
4/240 • Number of events 4 • All-cause mortality and adverse events (AEs): up to approximately 4 years and 11 months
All-cause mortality is reported for all randomized participants; Serious and other AEs include participants who received at least one dose of study drug. AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
|
General disorders
Fatigue
|
0.78%
2/255 • Number of events 2 • All-cause mortality and adverse events (AEs): up to approximately 4 years and 11 months
All-cause mortality is reported for all randomized participants; Serious and other AEs include participants who received at least one dose of study drug. AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
0.00%
0/240 • All-cause mortality and adverse events (AEs): up to approximately 4 years and 11 months
All-cause mortality is reported for all randomized participants; Serious and other AEs include participants who received at least one dose of study drug. AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
|
General disorders
General physical health deterioration
|
1.2%
3/255 • Number of events 3 • All-cause mortality and adverse events (AEs): up to approximately 4 years and 11 months
All-cause mortality is reported for all randomized participants; Serious and other AEs include participants who received at least one dose of study drug. AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
1.7%
4/240 • Number of events 5 • All-cause mortality and adverse events (AEs): up to approximately 4 years and 11 months
All-cause mortality is reported for all randomized participants; Serious and other AEs include participants who received at least one dose of study drug. AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
|
General disorders
Malaise
|
0.00%
0/255 • All-cause mortality and adverse events (AEs): up to approximately 4 years and 11 months
All-cause mortality is reported for all randomized participants; Serious and other AEs include participants who received at least one dose of study drug. AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
0.83%
2/240 • Number of events 2 • All-cause mortality and adverse events (AEs): up to approximately 4 years and 11 months
All-cause mortality is reported for all randomized participants; Serious and other AEs include participants who received at least one dose of study drug. AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
|
General disorders
Multiple organ dysfunction syndrome
|
1.2%
3/255 • Number of events 4 • All-cause mortality and adverse events (AEs): up to approximately 4 years and 11 months
All-cause mortality is reported for all randomized participants; Serious and other AEs include participants who received at least one dose of study drug. AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
0.42%
1/240 • Number of events 1 • All-cause mortality and adverse events (AEs): up to approximately 4 years and 11 months
All-cause mortality is reported for all randomized participants; Serious and other AEs include participants who received at least one dose of study drug. AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
|
General disorders
Oedema peripheral
|
0.39%
1/255 • Number of events 1 • All-cause mortality and adverse events (AEs): up to approximately 4 years and 11 months
All-cause mortality is reported for all randomized participants; Serious and other AEs include participants who received at least one dose of study drug. AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
0.00%
0/240 • All-cause mortality and adverse events (AEs): up to approximately 4 years and 11 months
All-cause mortality is reported for all randomized participants; Serious and other AEs include participants who received at least one dose of study drug. AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
|
General disorders
Pyrexia
|
0.78%
2/255 • Number of events 2 • All-cause mortality and adverse events (AEs): up to approximately 4 years and 11 months
All-cause mortality is reported for all randomized participants; Serious and other AEs include participants who received at least one dose of study drug. AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
0.83%
2/240 • Number of events 2 • All-cause mortality and adverse events (AEs): up to approximately 4 years and 11 months
All-cause mortality is reported for all randomized participants; Serious and other AEs include participants who received at least one dose of study drug. AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
|
General disorders
Sudden death
|
0.39%
1/255 • Number of events 1 • All-cause mortality and adverse events (AEs): up to approximately 4 years and 11 months
All-cause mortality is reported for all randomized participants; Serious and other AEs include participants who received at least one dose of study drug. AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
0.42%
1/240 • Number of events 1 • All-cause mortality and adverse events (AEs): up to approximately 4 years and 11 months
All-cause mortality is reported for all randomized participants; Serious and other AEs include participants who received at least one dose of study drug. AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
|
Hepatobiliary disorders
Biliary obstruction
|
0.39%
1/255 • Number of events 1 • All-cause mortality and adverse events (AEs): up to approximately 4 years and 11 months
All-cause mortality is reported for all randomized participants; Serious and other AEs include participants who received at least one dose of study drug. AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
0.42%
1/240 • Number of events 1 • All-cause mortality and adverse events (AEs): up to approximately 4 years and 11 months
All-cause mortality is reported for all randomized participants; Serious and other AEs include participants who received at least one dose of study drug. AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
|
Hepatobiliary disorders
Immune-mediated hepatitis
|
0.39%
1/255 • Number of events 2 • All-cause mortality and adverse events (AEs): up to approximately 4 years and 11 months
All-cause mortality is reported for all randomized participants; Serious and other AEs include participants who received at least one dose of study drug. AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
0.00%
0/240 • All-cause mortality and adverse events (AEs): up to approximately 4 years and 11 months
All-cause mortality is reported for all randomized participants; Serious and other AEs include participants who received at least one dose of study drug. AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
|
Hepatobiliary disorders
Jaundice cholestatic
|
0.39%
1/255 • Number of events 1 • All-cause mortality and adverse events (AEs): up to approximately 4 years and 11 months
All-cause mortality is reported for all randomized participants; Serious and other AEs include participants who received at least one dose of study drug. AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
0.00%
0/240 • All-cause mortality and adverse events (AEs): up to approximately 4 years and 11 months
All-cause mortality is reported for all randomized participants; Serious and other AEs include participants who received at least one dose of study drug. AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
|
Immune system disorders
Anaphylactic shock
|
0.00%
0/255 • All-cause mortality and adverse events (AEs): up to approximately 4 years and 11 months
All-cause mortality is reported for all randomized participants; Serious and other AEs include participants who received at least one dose of study drug. AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
0.42%
1/240 • Number of events 1 • All-cause mortality and adverse events (AEs): up to approximately 4 years and 11 months
All-cause mortality is reported for all randomized participants; Serious and other AEs include participants who received at least one dose of study drug. AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
|
Infections and infestations
Abscess neck
|
0.39%
1/255 • Number of events 1 • All-cause mortality and adverse events (AEs): up to approximately 4 years and 11 months
All-cause mortality is reported for all randomized participants; Serious and other AEs include participants who received at least one dose of study drug. AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
0.00%
0/240 • All-cause mortality and adverse events (AEs): up to approximately 4 years and 11 months
All-cause mortality is reported for all randomized participants; Serious and other AEs include participants who received at least one dose of study drug. AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
|
Infections and infestations
Biliary tract infection
|
0.39%
1/255 • Number of events 1 • All-cause mortality and adverse events (AEs): up to approximately 4 years and 11 months
All-cause mortality is reported for all randomized participants; Serious and other AEs include participants who received at least one dose of study drug. AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
0.00%
0/240 • All-cause mortality and adverse events (AEs): up to approximately 4 years and 11 months
All-cause mortality is reported for all randomized participants; Serious and other AEs include participants who received at least one dose of study drug. AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
|
Infections and infestations
Bronchitis
|
0.39%
1/255 • Number of events 1 • All-cause mortality and adverse events (AEs): up to approximately 4 years and 11 months
All-cause mortality is reported for all randomized participants; Serious and other AEs include participants who received at least one dose of study drug. AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
0.00%
0/240 • All-cause mortality and adverse events (AEs): up to approximately 4 years and 11 months
All-cause mortality is reported for all randomized participants; Serious and other AEs include participants who received at least one dose of study drug. AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
|
Infections and infestations
COVID-19
|
0.00%
0/255 • All-cause mortality and adverse events (AEs): up to approximately 4 years and 11 months
All-cause mortality is reported for all randomized participants; Serious and other AEs include participants who received at least one dose of study drug. AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
0.42%
1/240 • Number of events 1 • All-cause mortality and adverse events (AEs): up to approximately 4 years and 11 months
All-cause mortality is reported for all randomized participants; Serious and other AEs include participants who received at least one dose of study drug. AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
|
Infections and infestations
Device related infection
|
0.00%
0/255 • All-cause mortality and adverse events (AEs): up to approximately 4 years and 11 months
All-cause mortality is reported for all randomized participants; Serious and other AEs include participants who received at least one dose of study drug. AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
0.42%
1/240 • Number of events 1 • All-cause mortality and adverse events (AEs): up to approximately 4 years and 11 months
All-cause mortality is reported for all randomized participants; Serious and other AEs include participants who received at least one dose of study drug. AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
|
Infections and infestations
Infection
|
0.00%
0/255 • All-cause mortality and adverse events (AEs): up to approximately 4 years and 11 months
All-cause mortality is reported for all randomized participants; Serious and other AEs include participants who received at least one dose of study drug. AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
0.42%
1/240 • Number of events 1 • All-cause mortality and adverse events (AEs): up to approximately 4 years and 11 months
All-cause mortality is reported for all randomized participants; Serious and other AEs include participants who received at least one dose of study drug. AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
|
Infections and infestations
Peritonitis
|
0.00%
0/255 • All-cause mortality and adverse events (AEs): up to approximately 4 years and 11 months
All-cause mortality is reported for all randomized participants; Serious and other AEs include participants who received at least one dose of study drug. AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
0.42%
1/240 • Number of events 1 • All-cause mortality and adverse events (AEs): up to approximately 4 years and 11 months
All-cause mortality is reported for all randomized participants; Serious and other AEs include participants who received at least one dose of study drug. AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
|
Infections and infestations
Pneumonia
|
7.5%
19/255 • Number of events 24 • All-cause mortality and adverse events (AEs): up to approximately 4 years and 11 months
All-cause mortality is reported for all randomized participants; Serious and other AEs include participants who received at least one dose of study drug. AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
7.1%
17/240 • Number of events 18 • All-cause mortality and adverse events (AEs): up to approximately 4 years and 11 months
All-cause mortality is reported for all randomized participants; Serious and other AEs include participants who received at least one dose of study drug. AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
|
Infections and infestations
Pneumonia aspiration
|
1.2%
3/255 • Number of events 3 • All-cause mortality and adverse events (AEs): up to approximately 4 years and 11 months
All-cause mortality is reported for all randomized participants; Serious and other AEs include participants who received at least one dose of study drug. AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
0.42%
1/240 • Number of events 2 • All-cause mortality and adverse events (AEs): up to approximately 4 years and 11 months
All-cause mortality is reported for all randomized participants; Serious and other AEs include participants who received at least one dose of study drug. AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
|
Infections and infestations
Pneumonia bacterial
|
0.39%
1/255 • Number of events 1 • All-cause mortality and adverse events (AEs): up to approximately 4 years and 11 months
All-cause mortality is reported for all randomized participants; Serious and other AEs include participants who received at least one dose of study drug. AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
0.00%
0/240 • All-cause mortality and adverse events (AEs): up to approximately 4 years and 11 months
All-cause mortality is reported for all randomized participants; Serious and other AEs include participants who received at least one dose of study drug. AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
|
Infections and infestations
Respiratory tract infection
|
0.00%
0/255 • All-cause mortality and adverse events (AEs): up to approximately 4 years and 11 months
All-cause mortality is reported for all randomized participants; Serious and other AEs include participants who received at least one dose of study drug. AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
0.42%
1/240 • Number of events 1 • All-cause mortality and adverse events (AEs): up to approximately 4 years and 11 months
All-cause mortality is reported for all randomized participants; Serious and other AEs include participants who received at least one dose of study drug. AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
|
Infections and infestations
Sepsis
|
0.78%
2/255 • Number of events 4 • All-cause mortality and adverse events (AEs): up to approximately 4 years and 11 months
All-cause mortality is reported for all randomized participants; Serious and other AEs include participants who received at least one dose of study drug. AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
0.42%
1/240 • Number of events 1 • All-cause mortality and adverse events (AEs): up to approximately 4 years and 11 months
All-cause mortality is reported for all randomized participants; Serious and other AEs include participants who received at least one dose of study drug. AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
|
Infections and infestations
Septic shock
|
0.39%
1/255 • Number of events 2 • All-cause mortality and adverse events (AEs): up to approximately 4 years and 11 months
All-cause mortality is reported for all randomized participants; Serious and other AEs include participants who received at least one dose of study drug. AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
1.7%
4/240 • Number of events 4 • All-cause mortality and adverse events (AEs): up to approximately 4 years and 11 months
All-cause mortality is reported for all randomized participants; Serious and other AEs include participants who received at least one dose of study drug. AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
|
Infections and infestations
Testicular abscess
|
0.39%
1/255 • Number of events 1 • All-cause mortality and adverse events (AEs): up to approximately 4 years and 11 months
All-cause mortality is reported for all randomized participants; Serious and other AEs include participants who received at least one dose of study drug. AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
0.00%
0/240 • All-cause mortality and adverse events (AEs): up to approximately 4 years and 11 months
All-cause mortality is reported for all randomized participants; Serious and other AEs include participants who received at least one dose of study drug. AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.39%
1/255 • Number of events 1 • All-cause mortality and adverse events (AEs): up to approximately 4 years and 11 months
All-cause mortality is reported for all randomized participants; Serious and other AEs include participants who received at least one dose of study drug. AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
0.00%
0/240 • All-cause mortality and adverse events (AEs): up to approximately 4 years and 11 months
All-cause mortality is reported for all randomized participants; Serious and other AEs include participants who received at least one dose of study drug. AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/255 • All-cause mortality and adverse events (AEs): up to approximately 4 years and 11 months
All-cause mortality is reported for all randomized participants; Serious and other AEs include participants who received at least one dose of study drug. AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
0.42%
1/240 • Number of events 1 • All-cause mortality and adverse events (AEs): up to approximately 4 years and 11 months
All-cause mortality is reported for all randomized participants; Serious and other AEs include participants who received at least one dose of study drug. AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
|
Infections and infestations
Vascular device infection
|
0.00%
0/255 • All-cause mortality and adverse events (AEs): up to approximately 4 years and 11 months
All-cause mortality is reported for all randomized participants; Serious and other AEs include participants who received at least one dose of study drug. AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
0.42%
1/240 • Number of events 1 • All-cause mortality and adverse events (AEs): up to approximately 4 years and 11 months
All-cause mortality is reported for all randomized participants; Serious and other AEs include participants who received at least one dose of study drug. AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
|
Infections and infestations
Wound infection
|
0.00%
0/255 • All-cause mortality and adverse events (AEs): up to approximately 4 years and 11 months
All-cause mortality is reported for all randomized participants; Serious and other AEs include participants who received at least one dose of study drug. AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
0.83%
2/240 • Number of events 3 • All-cause mortality and adverse events (AEs): up to approximately 4 years and 11 months
All-cause mortality is reported for all randomized participants; Serious and other AEs include participants who received at least one dose of study drug. AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
|
Injury, poisoning and procedural complications
Thoracic vertebral fracture
|
0.39%
1/255 • Number of events 1 • All-cause mortality and adverse events (AEs): up to approximately 4 years and 11 months
All-cause mortality is reported for all randomized participants; Serious and other AEs include participants who received at least one dose of study drug. AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
0.00%
0/240 • All-cause mortality and adverse events (AEs): up to approximately 4 years and 11 months
All-cause mortality is reported for all randomized participants; Serious and other AEs include participants who received at least one dose of study drug. AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
|
Injury, poisoning and procedural complications
Tracheal haemorrhage
|
0.39%
1/255 • Number of events 1 • All-cause mortality and adverse events (AEs): up to approximately 4 years and 11 months
All-cause mortality is reported for all randomized participants; Serious and other AEs include participants who received at least one dose of study drug. AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
0.00%
0/240 • All-cause mortality and adverse events (AEs): up to approximately 4 years and 11 months
All-cause mortality is reported for all randomized participants; Serious and other AEs include participants who received at least one dose of study drug. AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
|
Injury, poisoning and procedural complications
Tracheostomy malfunction
|
0.39%
1/255 • Number of events 2 • All-cause mortality and adverse events (AEs): up to approximately 4 years and 11 months
All-cause mortality is reported for all randomized participants; Serious and other AEs include participants who received at least one dose of study drug. AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
0.00%
0/240 • All-cause mortality and adverse events (AEs): up to approximately 4 years and 11 months
All-cause mortality is reported for all randomized participants; Serious and other AEs include participants who received at least one dose of study drug. AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
|
Investigations
Lymphocyte count decreased
|
0.00%
0/255 • All-cause mortality and adverse events (AEs): up to approximately 4 years and 11 months
All-cause mortality is reported for all randomized participants; Serious and other AEs include participants who received at least one dose of study drug. AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
0.42%
1/240 • Number of events 1 • All-cause mortality and adverse events (AEs): up to approximately 4 years and 11 months
All-cause mortality is reported for all randomized participants; Serious and other AEs include participants who received at least one dose of study drug. AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
|
Investigations
Neutrophil count decreased
|
0.00%
0/255 • All-cause mortality and adverse events (AEs): up to approximately 4 years and 11 months
All-cause mortality is reported for all randomized participants; Serious and other AEs include participants who received at least one dose of study drug. AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
4.2%
10/240 • Number of events 14 • All-cause mortality and adverse events (AEs): up to approximately 4 years and 11 months
All-cause mortality is reported for all randomized participants; Serious and other AEs include participants who received at least one dose of study drug. AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
|
Investigations
Platelet count decreased
|
0.39%
1/255 • Number of events 1 • All-cause mortality and adverse events (AEs): up to approximately 4 years and 11 months
All-cause mortality is reported for all randomized participants; Serious and other AEs include participants who received at least one dose of study drug. AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
0.00%
0/240 • All-cause mortality and adverse events (AEs): up to approximately 4 years and 11 months
All-cause mortality is reported for all randomized participants; Serious and other AEs include participants who received at least one dose of study drug. AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
|
Investigations
White blood cell count decreased
|
0.00%
0/255 • All-cause mortality and adverse events (AEs): up to approximately 4 years and 11 months
All-cause mortality is reported for all randomized participants; Serious and other AEs include participants who received at least one dose of study drug. AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
3.3%
8/240 • Number of events 11 • All-cause mortality and adverse events (AEs): up to approximately 4 years and 11 months
All-cause mortality is reported for all randomized participants; Serious and other AEs include participants who received at least one dose of study drug. AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.39%
1/255 • Number of events 1 • All-cause mortality and adverse events (AEs): up to approximately 4 years and 11 months
All-cause mortality is reported for all randomized participants; Serious and other AEs include participants who received at least one dose of study drug. AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
2.5%
6/240 • Number of events 6 • All-cause mortality and adverse events (AEs): up to approximately 4 years and 11 months
All-cause mortality is reported for all randomized participants; Serious and other AEs include participants who received at least one dose of study drug. AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
|
Metabolism and nutrition disorders
Electrolyte imbalance
|
0.39%
1/255 • Number of events 1 • All-cause mortality and adverse events (AEs): up to approximately 4 years and 11 months
All-cause mortality is reported for all randomized participants; Serious and other AEs include participants who received at least one dose of study drug. AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
0.00%
0/240 • All-cause mortality and adverse events (AEs): up to approximately 4 years and 11 months
All-cause mortality is reported for all randomized participants; Serious and other AEs include participants who received at least one dose of study drug. AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
0.78%
2/255 • Number of events 5 • All-cause mortality and adverse events (AEs): up to approximately 4 years and 11 months
All-cause mortality is reported for all randomized participants; Serious and other AEs include participants who received at least one dose of study drug. AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
0.00%
0/240 • All-cause mortality and adverse events (AEs): up to approximately 4 years and 11 months
All-cause mortality is reported for all randomized participants; Serious and other AEs include participants who received at least one dose of study drug. AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
|
Metabolism and nutrition disorders
Hypernatraemia
|
0.39%
1/255 • Number of events 1 • All-cause mortality and adverse events (AEs): up to approximately 4 years and 11 months
All-cause mortality is reported for all randomized participants; Serious and other AEs include participants who received at least one dose of study drug. AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
0.00%
0/240 • All-cause mortality and adverse events (AEs): up to approximately 4 years and 11 months
All-cause mortality is reported for all randomized participants; Serious and other AEs include participants who received at least one dose of study drug. AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
0.39%
1/255 • Number of events 1 • All-cause mortality and adverse events (AEs): up to approximately 4 years and 11 months
All-cause mortality is reported for all randomized participants; Serious and other AEs include participants who received at least one dose of study drug. AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
0.00%
0/240 • All-cause mortality and adverse events (AEs): up to approximately 4 years and 11 months
All-cause mortality is reported for all randomized participants; Serious and other AEs include participants who received at least one dose of study drug. AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
|
Metabolism and nutrition disorders
Hypochloraemia
|
0.39%
1/255 • Number of events 1 • All-cause mortality and adverse events (AEs): up to approximately 4 years and 11 months
All-cause mortality is reported for all randomized participants; Serious and other AEs include participants who received at least one dose of study drug. AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
0.00%
0/240 • All-cause mortality and adverse events (AEs): up to approximately 4 years and 11 months
All-cause mortality is reported for all randomized participants; Serious and other AEs include participants who received at least one dose of study drug. AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/255 • All-cause mortality and adverse events (AEs): up to approximately 4 years and 11 months
All-cause mortality is reported for all randomized participants; Serious and other AEs include participants who received at least one dose of study drug. AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
0.42%
1/240 • Number of events 1 • All-cause mortality and adverse events (AEs): up to approximately 4 years and 11 months
All-cause mortality is reported for all randomized participants; Serious and other AEs include participants who received at least one dose of study drug. AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
1.6%
4/255 • Number of events 7 • All-cause mortality and adverse events (AEs): up to approximately 4 years and 11 months
All-cause mortality is reported for all randomized participants; Serious and other AEs include participants who received at least one dose of study drug. AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
0.00%
0/240 • All-cause mortality and adverse events (AEs): up to approximately 4 years and 11 months
All-cause mortality is reported for all randomized participants; Serious and other AEs include participants who received at least one dose of study drug. AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
0.39%
1/255 • Number of events 1 • All-cause mortality and adverse events (AEs): up to approximately 4 years and 11 months
All-cause mortality is reported for all randomized participants; Serious and other AEs include participants who received at least one dose of study drug. AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
0.00%
0/240 • All-cause mortality and adverse events (AEs): up to approximately 4 years and 11 months
All-cause mortality is reported for all randomized participants; Serious and other AEs include participants who received at least one dose of study drug. AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
|
Metabolism and nutrition disorders
Type 1 diabetes mellitus
|
0.78%
2/255 • Number of events 2 • All-cause mortality and adverse events (AEs): up to approximately 4 years and 11 months
All-cause mortality is reported for all randomized participants; Serious and other AEs include participants who received at least one dose of study drug. AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
0.00%
0/240 • All-cause mortality and adverse events (AEs): up to approximately 4 years and 11 months
All-cause mortality is reported for all randomized participants; Serious and other AEs include participants who received at least one dose of study drug. AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.39%
1/255 • Number of events 2 • All-cause mortality and adverse events (AEs): up to approximately 4 years and 11 months
All-cause mortality is reported for all randomized participants; Serious and other AEs include participants who received at least one dose of study drug. AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
0.42%
1/240 • Number of events 1 • All-cause mortality and adverse events (AEs): up to approximately 4 years and 11 months
All-cause mortality is reported for all randomized participants; Serious and other AEs include participants who received at least one dose of study drug. AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
0.39%
1/255 • Number of events 1 • All-cause mortality and adverse events (AEs): up to approximately 4 years and 11 months
All-cause mortality is reported for all randomized participants; Serious and other AEs include participants who received at least one dose of study drug. AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
0.00%
0/240 • All-cause mortality and adverse events (AEs): up to approximately 4 years and 11 months
All-cause mortality is reported for all randomized participants; Serious and other AEs include participants who received at least one dose of study drug. AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
|
Musculoskeletal and connective tissue disorders
Immune-mediated myositis
|
0.78%
2/255 • Number of events 4 • All-cause mortality and adverse events (AEs): up to approximately 4 years and 11 months
All-cause mortality is reported for all randomized participants; Serious and other AEs include participants who received at least one dose of study drug. AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
0.00%
0/240 • All-cause mortality and adverse events (AEs): up to approximately 4 years and 11 months
All-cause mortality is reported for all randomized participants; Serious and other AEs include participants who received at least one dose of study drug. AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.00%
0/255 • All-cause mortality and adverse events (AEs): up to approximately 4 years and 11 months
All-cause mortality is reported for all randomized participants; Serious and other AEs include participants who received at least one dose of study drug. AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
0.42%
1/240 • Number of events 1 • All-cause mortality and adverse events (AEs): up to approximately 4 years and 11 months
All-cause mortality is reported for all randomized participants; Serious and other AEs include participants who received at least one dose of study drug. AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.39%
1/255 • Number of events 1 • All-cause mortality and adverse events (AEs): up to approximately 4 years and 11 months
All-cause mortality is reported for all randomized participants; Serious and other AEs include participants who received at least one dose of study drug. AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
0.00%
0/240 • All-cause mortality and adverse events (AEs): up to approximately 4 years and 11 months
All-cause mortality is reported for all randomized participants; Serious and other AEs include participants who received at least one dose of study drug. AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.39%
1/255 • Number of events 1 • All-cause mortality and adverse events (AEs): up to approximately 4 years and 11 months
All-cause mortality is reported for all randomized participants; Serious and other AEs include participants who received at least one dose of study drug. AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
0.00%
0/240 • All-cause mortality and adverse events (AEs): up to approximately 4 years and 11 months
All-cause mortality is reported for all randomized participants; Serious and other AEs include participants who received at least one dose of study drug. AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
|
Musculoskeletal and connective tissue disorders
Pathological fracture
|
0.00%
0/255 • All-cause mortality and adverse events (AEs): up to approximately 4 years and 11 months
All-cause mortality is reported for all randomized participants; Serious and other AEs include participants who received at least one dose of study drug. AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
0.42%
1/240 • Number of events 1 • All-cause mortality and adverse events (AEs): up to approximately 4 years and 11 months
All-cause mortality is reported for all randomized participants; Serious and other AEs include participants who received at least one dose of study drug. AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cancer pain
|
0.00%
0/255 • All-cause mortality and adverse events (AEs): up to approximately 4 years and 11 months
All-cause mortality is reported for all randomized participants; Serious and other AEs include participants who received at least one dose of study drug. AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
0.42%
1/240 • Number of events 1 • All-cause mortality and adverse events (AEs): up to approximately 4 years and 11 months
All-cause mortality is reported for all randomized participants; Serious and other AEs include participants who received at least one dose of study drug. AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to heart
|
0.39%
1/255 • Number of events 1 • All-cause mortality and adverse events (AEs): up to approximately 4 years and 11 months
All-cause mortality is reported for all randomized participants; Serious and other AEs include participants who received at least one dose of study drug. AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
0.00%
0/240 • All-cause mortality and adverse events (AEs): up to approximately 4 years and 11 months
All-cause mortality is reported for all randomized participants; Serious and other AEs include participants who received at least one dose of study drug. AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to liver
|
0.39%
1/255 • Number of events 1 • All-cause mortality and adverse events (AEs): up to approximately 4 years and 11 months
All-cause mortality is reported for all randomized participants; Serious and other AEs include participants who received at least one dose of study drug. AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
0.00%
0/240 • All-cause mortality and adverse events (AEs): up to approximately 4 years and 11 months
All-cause mortality is reported for all randomized participants; Serious and other AEs include participants who received at least one dose of study drug. AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour compression
|
0.39%
1/255 • Number of events 1 • All-cause mortality and adverse events (AEs): up to approximately 4 years and 11 months
All-cause mortality is reported for all randomized participants; Serious and other AEs include participants who received at least one dose of study drug. AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
0.00%
0/240 • All-cause mortality and adverse events (AEs): up to approximately 4 years and 11 months
All-cause mortality is reported for all randomized participants; Serious and other AEs include participants who received at least one dose of study drug. AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour fistulisation
|
0.39%
1/255 • Number of events 1 • All-cause mortality and adverse events (AEs): up to approximately 4 years and 11 months
All-cause mortality is reported for all randomized participants; Serious and other AEs include participants who received at least one dose of study drug. AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
0.00%
0/240 • All-cause mortality and adverse events (AEs): up to approximately 4 years and 11 months
All-cause mortality is reported for all randomized participants; Serious and other AEs include participants who received at least one dose of study drug. AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour haemorrhage
|
0.39%
1/255 • Number of events 1 • All-cause mortality and adverse events (AEs): up to approximately 4 years and 11 months
All-cause mortality is reported for all randomized participants; Serious and other AEs include participants who received at least one dose of study drug. AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
0.83%
2/240 • Number of events 4 • All-cause mortality and adverse events (AEs): up to approximately 4 years and 11 months
All-cause mortality is reported for all randomized participants; Serious and other AEs include participants who received at least one dose of study drug. AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour pain
|
0.78%
2/255 • Number of events 2 • All-cause mortality and adverse events (AEs): up to approximately 4 years and 11 months
All-cause mortality is reported for all randomized participants; Serious and other AEs include participants who received at least one dose of study drug. AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
0.42%
1/240 • Number of events 2 • All-cause mortality and adverse events (AEs): up to approximately 4 years and 11 months
All-cause mortality is reported for all randomized participants; Serious and other AEs include participants who received at least one dose of study drug. AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
|
Nervous system disorders
Altered state of consciousness
|
0.39%
1/255 • Number of events 1 • All-cause mortality and adverse events (AEs): up to approximately 4 years and 11 months
All-cause mortality is reported for all randomized participants; Serious and other AEs include participants who received at least one dose of study drug. AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
0.00%
0/240 • All-cause mortality and adverse events (AEs): up to approximately 4 years and 11 months
All-cause mortality is reported for all randomized participants; Serious and other AEs include participants who received at least one dose of study drug. AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
|
Nervous system disorders
Ataxia
|
0.39%
1/255 • Number of events 1 • All-cause mortality and adverse events (AEs): up to approximately 4 years and 11 months
All-cause mortality is reported for all randomized participants; Serious and other AEs include participants who received at least one dose of study drug. AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
0.00%
0/240 • All-cause mortality and adverse events (AEs): up to approximately 4 years and 11 months
All-cause mortality is reported for all randomized participants; Serious and other AEs include participants who received at least one dose of study drug. AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
|
Nervous system disorders
Brain oedema
|
0.00%
0/255 • All-cause mortality and adverse events (AEs): up to approximately 4 years and 11 months
All-cause mortality is reported for all randomized participants; Serious and other AEs include participants who received at least one dose of study drug. AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
0.42%
1/240 • Number of events 1 • All-cause mortality and adverse events (AEs): up to approximately 4 years and 11 months
All-cause mortality is reported for all randomized participants; Serious and other AEs include participants who received at least one dose of study drug. AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
|
Nervous system disorders
Cerebral infarction
|
0.00%
0/255 • All-cause mortality and adverse events (AEs): up to approximately 4 years and 11 months
All-cause mortality is reported for all randomized participants; Serious and other AEs include participants who received at least one dose of study drug. AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
0.42%
1/240 • Number of events 2 • All-cause mortality and adverse events (AEs): up to approximately 4 years and 11 months
All-cause mortality is reported for all randomized participants; Serious and other AEs include participants who received at least one dose of study drug. AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
|
Nervous system disorders
Depressed level of consciousness
|
0.39%
1/255 • Number of events 1 • All-cause mortality and adverse events (AEs): up to approximately 4 years and 11 months
All-cause mortality is reported for all randomized participants; Serious and other AEs include participants who received at least one dose of study drug. AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
0.42%
1/240 • Number of events 1 • All-cause mortality and adverse events (AEs): up to approximately 4 years and 11 months
All-cause mortality is reported for all randomized participants; Serious and other AEs include participants who received at least one dose of study drug. AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
|
Nervous system disorders
Spinal cord compression
|
0.00%
0/255 • All-cause mortality and adverse events (AEs): up to approximately 4 years and 11 months
All-cause mortality is reported for all randomized participants; Serious and other AEs include participants who received at least one dose of study drug. AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
0.42%
1/240 • Number of events 1 • All-cause mortality and adverse events (AEs): up to approximately 4 years and 11 months
All-cause mortality is reported for all randomized participants; Serious and other AEs include participants who received at least one dose of study drug. AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
|
Nervous system disorders
Syncope
|
0.00%
0/255 • All-cause mortality and adverse events (AEs): up to approximately 4 years and 11 months
All-cause mortality is reported for all randomized participants; Serious and other AEs include participants who received at least one dose of study drug. AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
0.42%
1/240 • Number of events 1 • All-cause mortality and adverse events (AEs): up to approximately 4 years and 11 months
All-cause mortality is reported for all randomized participants; Serious and other AEs include participants who received at least one dose of study drug. AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
|
Psychiatric disorders
Delirium
|
0.00%
0/255 • All-cause mortality and adverse events (AEs): up to approximately 4 years and 11 months
All-cause mortality is reported for all randomized participants; Serious and other AEs include participants who received at least one dose of study drug. AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
0.42%
1/240 • Number of events 1 • All-cause mortality and adverse events (AEs): up to approximately 4 years and 11 months
All-cause mortality is reported for all randomized participants; Serious and other AEs include participants who received at least one dose of study drug. AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
|
Renal and urinary disorders
Nephroangiosclerosis
|
0.39%
1/255 • Number of events 1 • All-cause mortality and adverse events (AEs): up to approximately 4 years and 11 months
All-cause mortality is reported for all randomized participants; Serious and other AEs include participants who received at least one dose of study drug. AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
0.00%
0/240 • All-cause mortality and adverse events (AEs): up to approximately 4 years and 11 months
All-cause mortality is reported for all randomized participants; Serious and other AEs include participants who received at least one dose of study drug. AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
|
Respiratory, thoracic and mediastinal disorders
Acquired tracheo-oesophageal fistula
|
0.39%
1/255 • Number of events 1 • All-cause mortality and adverse events (AEs): up to approximately 4 years and 11 months
All-cause mortality is reported for all randomized participants; Serious and other AEs include participants who received at least one dose of study drug. AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
1.7%
4/240 • Number of events 4 • All-cause mortality and adverse events (AEs): up to approximately 4 years and 11 months
All-cause mortality is reported for all randomized participants; Serious and other AEs include participants who received at least one dose of study drug. AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
0.39%
1/255 • Number of events 1 • All-cause mortality and adverse events (AEs): up to approximately 4 years and 11 months
All-cause mortality is reported for all randomized participants; Serious and other AEs include participants who received at least one dose of study drug. AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
0.00%
0/240 • All-cause mortality and adverse events (AEs): up to approximately 4 years and 11 months
All-cause mortality is reported for all randomized participants; Serious and other AEs include participants who received at least one dose of study drug. AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchiectasis
|
0.39%
1/255 • Number of events 2 • All-cause mortality and adverse events (AEs): up to approximately 4 years and 11 months
All-cause mortality is reported for all randomized participants; Serious and other AEs include participants who received at least one dose of study drug. AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
0.00%
0/240 • All-cause mortality and adverse events (AEs): up to approximately 4 years and 11 months
All-cause mortality is reported for all randomized participants; Serious and other AEs include participants who received at least one dose of study drug. AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.39%
1/255 • Number of events 1 • All-cause mortality and adverse events (AEs): up to approximately 4 years and 11 months
All-cause mortality is reported for all randomized participants; Serious and other AEs include participants who received at least one dose of study drug. AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
0.00%
0/240 • All-cause mortality and adverse events (AEs): up to approximately 4 years and 11 months
All-cause mortality is reported for all randomized participants; Serious and other AEs include participants who received at least one dose of study drug. AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
1.2%
3/255 • Number of events 4 • All-cause mortality and adverse events (AEs): up to approximately 4 years and 11 months
All-cause mortality is reported for all randomized participants; Serious and other AEs include participants who received at least one dose of study drug. AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
0.42%
1/240 • Number of events 2 • All-cause mortality and adverse events (AEs): up to approximately 4 years and 11 months
All-cause mortality is reported for all randomized participants; Serious and other AEs include participants who received at least one dose of study drug. AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
0.39%
1/255 • Number of events 1 • All-cause mortality and adverse events (AEs): up to approximately 4 years and 11 months
All-cause mortality is reported for all randomized participants; Serious and other AEs include participants who received at least one dose of study drug. AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
0.83%
2/240 • Number of events 2 • All-cause mortality and adverse events (AEs): up to approximately 4 years and 11 months
All-cause mortality is reported for all randomized participants; Serious and other AEs include participants who received at least one dose of study drug. AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
|
Respiratory, thoracic and mediastinal disorders
Immune-mediated lung disease
|
1.2%
3/255 • Number of events 3 • All-cause mortality and adverse events (AEs): up to approximately 4 years and 11 months
All-cause mortality is reported for all randomized participants; Serious and other AEs include participants who received at least one dose of study drug. AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
0.00%
0/240 • All-cause mortality and adverse events (AEs): up to approximately 4 years and 11 months
All-cause mortality is reported for all randomized participants; Serious and other AEs include participants who received at least one dose of study drug. AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
|
Respiratory, thoracic and mediastinal disorders
Lung disorder
|
0.39%
1/255 • Number of events 1 • All-cause mortality and adverse events (AEs): up to approximately 4 years and 11 months
All-cause mortality is reported for all randomized participants; Serious and other AEs include participants who received at least one dose of study drug. AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
0.00%
0/240 • All-cause mortality and adverse events (AEs): up to approximately 4 years and 11 months
All-cause mortality is reported for all randomized participants; Serious and other AEs include participants who received at least one dose of study drug. AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
|
Respiratory, thoracic and mediastinal disorders
Oesophagobronchial fistula
|
0.39%
1/255 • Number of events 2 • All-cause mortality and adverse events (AEs): up to approximately 4 years and 11 months
All-cause mortality is reported for all randomized participants; Serious and other AEs include participants who received at least one dose of study drug. AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
0.42%
1/240 • Number of events 2 • All-cause mortality and adverse events (AEs): up to approximately 4 years and 11 months
All-cause mortality is reported for all randomized participants; Serious and other AEs include participants who received at least one dose of study drug. AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
1.2%
3/255 • Number of events 3 • All-cause mortality and adverse events (AEs): up to approximately 4 years and 11 months
All-cause mortality is reported for all randomized participants; Serious and other AEs include participants who received at least one dose of study drug. AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
1.7%
4/240 • Number of events 4 • All-cause mortality and adverse events (AEs): up to approximately 4 years and 11 months
All-cause mortality is reported for all randomized participants; Serious and other AEs include participants who received at least one dose of study drug. AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
2.0%
5/255 • Number of events 5 • All-cause mortality and adverse events (AEs): up to approximately 4 years and 11 months
All-cause mortality is reported for all randomized participants; Serious and other AEs include participants who received at least one dose of study drug. AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
0.83%
2/240 • Number of events 2 • All-cause mortality and adverse events (AEs): up to approximately 4 years and 11 months
All-cause mortality is reported for all randomized participants; Serious and other AEs include participants who received at least one dose of study drug. AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.00%
0/255 • All-cause mortality and adverse events (AEs): up to approximately 4 years and 11 months
All-cause mortality is reported for all randomized participants; Serious and other AEs include participants who received at least one dose of study drug. AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
0.42%
1/240 • Number of events 1 • All-cause mortality and adverse events (AEs): up to approximately 4 years and 11 months
All-cause mortality is reported for all randomized participants; Serious and other AEs include participants who received at least one dose of study drug. AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary arterial hypertension
|
0.39%
1/255 • Number of events 6 • All-cause mortality and adverse events (AEs): up to approximately 4 years and 11 months
All-cause mortality is reported for all randomized participants; Serious and other AEs include participants who received at least one dose of study drug. AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
0.00%
0/240 • All-cause mortality and adverse events (AEs): up to approximately 4 years and 11 months
All-cause mortality is reported for all randomized participants; Serious and other AEs include participants who received at least one dose of study drug. AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.78%
2/255 • Number of events 3 • All-cause mortality and adverse events (AEs): up to approximately 4 years and 11 months
All-cause mortality is reported for all randomized participants; Serious and other AEs include participants who received at least one dose of study drug. AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
0.42%
1/240 • Number of events 1 • All-cause mortality and adverse events (AEs): up to approximately 4 years and 11 months
All-cause mortality is reported for all randomized participants; Serious and other AEs include participants who received at least one dose of study drug. AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary haemorrhage
|
0.78%
2/255 • Number of events 2 • All-cause mortality and adverse events (AEs): up to approximately 4 years and 11 months
All-cause mortality is reported for all randomized participants; Serious and other AEs include participants who received at least one dose of study drug. AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
0.00%
0/240 • All-cause mortality and adverse events (AEs): up to approximately 4 years and 11 months
All-cause mortality is reported for all randomized participants; Serious and other AEs include participants who received at least one dose of study drug. AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.39%
1/255 • Number of events 1 • All-cause mortality and adverse events (AEs): up to approximately 4 years and 11 months
All-cause mortality is reported for all randomized participants; Serious and other AEs include participants who received at least one dose of study drug. AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
0.42%
1/240 • Number of events 1 • All-cause mortality and adverse events (AEs): up to approximately 4 years and 11 months
All-cause mortality is reported for all randomized participants; Serious and other AEs include participants who received at least one dose of study drug. AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
|
Respiratory, thoracic and mediastinal disorders
Tracheal fistula
|
0.00%
0/255 • All-cause mortality and adverse events (AEs): up to approximately 4 years and 11 months
All-cause mortality is reported for all randomized participants; Serious and other AEs include participants who received at least one dose of study drug. AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
0.42%
1/240 • Number of events 1 • All-cause mortality and adverse events (AEs): up to approximately 4 years and 11 months
All-cause mortality is reported for all randomized participants; Serious and other AEs include participants who received at least one dose of study drug. AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
|
Respiratory, thoracic and mediastinal disorders
Tracheal stenosis
|
0.39%
1/255 • Number of events 1 • All-cause mortality and adverse events (AEs): up to approximately 4 years and 11 months
All-cause mortality is reported for all randomized participants; Serious and other AEs include participants who received at least one dose of study drug. AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
0.00%
0/240 • All-cause mortality and adverse events (AEs): up to approximately 4 years and 11 months
All-cause mortality is reported for all randomized participants; Serious and other AEs include participants who received at least one dose of study drug. AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.39%
1/255 • Number of events 1 • All-cause mortality and adverse events (AEs): up to approximately 4 years and 11 months
All-cause mortality is reported for all randomized participants; Serious and other AEs include participants who received at least one dose of study drug. AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
0.00%
0/240 • All-cause mortality and adverse events (AEs): up to approximately 4 years and 11 months
All-cause mortality is reported for all randomized participants; Serious and other AEs include participants who received at least one dose of study drug. AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
|
Vascular disorders
Hypotension
|
0.39%
1/255 • Number of events 1 • All-cause mortality and adverse events (AEs): up to approximately 4 years and 11 months
All-cause mortality is reported for all randomized participants; Serious and other AEs include participants who received at least one dose of study drug. AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
0.00%
0/240 • All-cause mortality and adverse events (AEs): up to approximately 4 years and 11 months
All-cause mortality is reported for all randomized participants; Serious and other AEs include participants who received at least one dose of study drug. AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
|
Vascular disorders
Superior vena cava syndrome
|
0.39%
1/255 • Number of events 2 • All-cause mortality and adverse events (AEs): up to approximately 4 years and 11 months
All-cause mortality is reported for all randomized participants; Serious and other AEs include participants who received at least one dose of study drug. AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
0.00%
0/240 • All-cause mortality and adverse events (AEs): up to approximately 4 years and 11 months
All-cause mortality is reported for all randomized participants; Serious and other AEs include participants who received at least one dose of study drug. AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
Other adverse events
| Measure |
Tislelizumab
n=255 participants at risk
Tislelizumab 200 mg intravenously (IV) on Day 1 every 21 days until disease progression, unacceptable toxicity, or other discontinuation criteria were met.
|
Investigator Chosen Chemotherapy (ICC)
n=240 participants at risk
Investigator choice of either paclitaxel 135-175 mg /m² on Day 1 IV every 21 days or 80-100 mg/m\^2 on a weekly schedule; docetaxel 75 mg/m\^2 IV on Day 1 every 21 days; or irinotecan 125 mg/m\^2 IV on Days 1 and 8 every 21 days
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
31.4%
80/255 • Number of events 139 • All-cause mortality and adverse events (AEs): up to approximately 4 years and 11 months
All-cause mortality is reported for all randomized participants; Serious and other AEs include participants who received at least one dose of study drug. AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
45.4%
109/240 • Number of events 192 • All-cause mortality and adverse events (AEs): up to approximately 4 years and 11 months
All-cause mortality is reported for all randomized participants; Serious and other AEs include participants who received at least one dose of study drug. AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
|
Blood and lymphatic system disorders
Leukopenia
|
3.5%
9/255 • Number of events 19 • All-cause mortality and adverse events (AEs): up to approximately 4 years and 11 months
All-cause mortality is reported for all randomized participants; Serious and other AEs include participants who received at least one dose of study drug. AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
12.1%
29/240 • Number of events 57 • All-cause mortality and adverse events (AEs): up to approximately 4 years and 11 months
All-cause mortality is reported for all randomized participants; Serious and other AEs include participants who received at least one dose of study drug. AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.78%
2/255 • Number of events 11 • All-cause mortality and adverse events (AEs): up to approximately 4 years and 11 months
All-cause mortality is reported for all randomized participants; Serious and other AEs include participants who received at least one dose of study drug. AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
12.5%
30/240 • Number of events 56 • All-cause mortality and adverse events (AEs): up to approximately 4 years and 11 months
All-cause mortality is reported for all randomized participants; Serious and other AEs include participants who received at least one dose of study drug. AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
2.0%
5/255 • Number of events 7 • All-cause mortality and adverse events (AEs): up to approximately 4 years and 11 months
All-cause mortality is reported for all randomized participants; Serious and other AEs include participants who received at least one dose of study drug. AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
4.2%
10/240 • Number of events 13 • All-cause mortality and adverse events (AEs): up to approximately 4 years and 11 months
All-cause mortality is reported for all randomized participants; Serious and other AEs include participants who received at least one dose of study drug. AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
|
Endocrine disorders
Hyperthyroidism
|
3.1%
8/255 • Number of events 8 • All-cause mortality and adverse events (AEs): up to approximately 4 years and 11 months
All-cause mortality is reported for all randomized participants; Serious and other AEs include participants who received at least one dose of study drug. AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
0.42%
1/240 • Number of events 1 • All-cause mortality and adverse events (AEs): up to approximately 4 years and 11 months
All-cause mortality is reported for all randomized participants; Serious and other AEs include participants who received at least one dose of study drug. AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
|
Endocrine disorders
Hypothyroidism
|
11.8%
30/255 • Number of events 37 • All-cause mortality and adverse events (AEs): up to approximately 4 years and 11 months
All-cause mortality is reported for all randomized participants; Serious and other AEs include participants who received at least one dose of study drug. AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
0.42%
1/240 • Number of events 1 • All-cause mortality and adverse events (AEs): up to approximately 4 years and 11 months
All-cause mortality is reported for all randomized participants; Serious and other AEs include participants who received at least one dose of study drug. AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
|
Gastrointestinal disorders
Abdominal distension
|
3.5%
9/255 • Number of events 10 • All-cause mortality and adverse events (AEs): up to approximately 4 years and 11 months
All-cause mortality is reported for all randomized participants; Serious and other AEs include participants who received at least one dose of study drug. AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
3.3%
8/240 • Number of events 9 • All-cause mortality and adverse events (AEs): up to approximately 4 years and 11 months
All-cause mortality is reported for all randomized participants; Serious and other AEs include participants who received at least one dose of study drug. AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
|
Gastrointestinal disorders
Abdominal pain
|
6.7%
17/255 • Number of events 20 • All-cause mortality and adverse events (AEs): up to approximately 4 years and 11 months
All-cause mortality is reported for all randomized participants; Serious and other AEs include participants who received at least one dose of study drug. AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
9.2%
22/240 • Number of events 27 • All-cause mortality and adverse events (AEs): up to approximately 4 years and 11 months
All-cause mortality is reported for all randomized participants; Serious and other AEs include participants who received at least one dose of study drug. AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
3.5%
9/255 • Number of events 12 • All-cause mortality and adverse events (AEs): up to approximately 4 years and 11 months
All-cause mortality is reported for all randomized participants; Serious and other AEs include participants who received at least one dose of study drug. AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
6.7%
16/240 • Number of events 18 • All-cause mortality and adverse events (AEs): up to approximately 4 years and 11 months
All-cause mortality is reported for all randomized participants; Serious and other AEs include participants who received at least one dose of study drug. AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
|
Gastrointestinal disorders
Constipation
|
16.1%
41/255 • Number of events 46 • All-cause mortality and adverse events (AEs): up to approximately 4 years and 11 months
All-cause mortality is reported for all randomized participants; Serious and other AEs include participants who received at least one dose of study drug. AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
18.8%
45/240 • Number of events 60 • All-cause mortality and adverse events (AEs): up to approximately 4 years and 11 months
All-cause mortality is reported for all randomized participants; Serious and other AEs include participants who received at least one dose of study drug. AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
|
Gastrointestinal disorders
Diarrhoea
|
12.5%
32/255 • Number of events 47 • All-cause mortality and adverse events (AEs): up to approximately 4 years and 11 months
All-cause mortality is reported for all randomized participants; Serious and other AEs include participants who received at least one dose of study drug. AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
31.2%
75/240 • Number of events 134 • All-cause mortality and adverse events (AEs): up to approximately 4 years and 11 months
All-cause mortality is reported for all randomized participants; Serious and other AEs include participants who received at least one dose of study drug. AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
|
Gastrointestinal disorders
Dysphagia
|
8.6%
22/255 • Number of events 23 • All-cause mortality and adverse events (AEs): up to approximately 4 years and 11 months
All-cause mortality is reported for all randomized participants; Serious and other AEs include participants who received at least one dose of study drug. AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
7.1%
17/240 • Number of events 22 • All-cause mortality and adverse events (AEs): up to approximately 4 years and 11 months
All-cause mortality is reported for all randomized participants; Serious and other AEs include participants who received at least one dose of study drug. AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
5.5%
14/255 • Number of events 16 • All-cause mortality and adverse events (AEs): up to approximately 4 years and 11 months
All-cause mortality is reported for all randomized participants; Serious and other AEs include participants who received at least one dose of study drug. AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
5.0%
12/240 • Number of events 13 • All-cause mortality and adverse events (AEs): up to approximately 4 years and 11 months
All-cause mortality is reported for all randomized participants; Serious and other AEs include participants who received at least one dose of study drug. AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
|
Gastrointestinal disorders
Nausea
|
14.5%
37/255 • Number of events 43 • All-cause mortality and adverse events (AEs): up to approximately 4 years and 11 months
All-cause mortality is reported for all randomized participants; Serious and other AEs include participants who received at least one dose of study drug. AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
30.0%
72/240 • Number of events 123 • All-cause mortality and adverse events (AEs): up to approximately 4 years and 11 months
All-cause mortality is reported for all randomized participants; Serious and other AEs include participants who received at least one dose of study drug. AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
|
Gastrointestinal disorders
Stomatitis
|
3.5%
9/255 • Number of events 10 • All-cause mortality and adverse events (AEs): up to approximately 4 years and 11 months
All-cause mortality is reported for all randomized participants; Serious and other AEs include participants who received at least one dose of study drug. AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
5.8%
14/240 • Number of events 21 • All-cause mortality and adverse events (AEs): up to approximately 4 years and 11 months
All-cause mortality is reported for all randomized participants; Serious and other AEs include participants who received at least one dose of study drug. AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
|
Gastrointestinal disorders
Vomiting
|
10.6%
27/255 • Number of events 33 • All-cause mortality and adverse events (AEs): up to approximately 4 years and 11 months
All-cause mortality is reported for all randomized participants; Serious and other AEs include participants who received at least one dose of study drug. AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
20.0%
48/240 • Number of events 88 • All-cause mortality and adverse events (AEs): up to approximately 4 years and 11 months
All-cause mortality is reported for all randomized participants; Serious and other AEs include participants who received at least one dose of study drug. AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
|
General disorders
Asthenia
|
11.4%
29/255 • Number of events 41 • All-cause mortality and adverse events (AEs): up to approximately 4 years and 11 months
All-cause mortality is reported for all randomized participants; Serious and other AEs include participants who received at least one dose of study drug. AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
15.0%
36/240 • Number of events 63 • All-cause mortality and adverse events (AEs): up to approximately 4 years and 11 months
All-cause mortality is reported for all randomized participants; Serious and other AEs include participants who received at least one dose of study drug. AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
|
General disorders
Fatigue
|
12.9%
33/255 • Number of events 43 • All-cause mortality and adverse events (AEs): up to approximately 4 years and 11 months
All-cause mortality is reported for all randomized participants; Serious and other AEs include participants who received at least one dose of study drug. AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
17.5%
42/240 • Number of events 68 • All-cause mortality and adverse events (AEs): up to approximately 4 years and 11 months
All-cause mortality is reported for all randomized participants; Serious and other AEs include participants who received at least one dose of study drug. AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
|
General disorders
Malaise
|
6.3%
16/255 • Number of events 18 • All-cause mortality and adverse events (AEs): up to approximately 4 years and 11 months
All-cause mortality is reported for all randomized participants; Serious and other AEs include participants who received at least one dose of study drug. AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
14.6%
35/240 • Number of events 54 • All-cause mortality and adverse events (AEs): up to approximately 4 years and 11 months
All-cause mortality is reported for all randomized participants; Serious and other AEs include participants who received at least one dose of study drug. AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
|
General disorders
Oedema peripheral
|
3.5%
9/255 • Number of events 12 • All-cause mortality and adverse events (AEs): up to approximately 4 years and 11 months
All-cause mortality is reported for all randomized participants; Serious and other AEs include participants who received at least one dose of study drug. AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
4.6%
11/240 • Number of events 13 • All-cause mortality and adverse events (AEs): up to approximately 4 years and 11 months
All-cause mortality is reported for all randomized participants; Serious and other AEs include participants who received at least one dose of study drug. AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
|
General disorders
Pyrexia
|
15.7%
40/255 • Number of events 56 • All-cause mortality and adverse events (AEs): up to approximately 4 years and 11 months
All-cause mortality is reported for all randomized participants; Serious and other AEs include participants who received at least one dose of study drug. AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
13.8%
33/240 • Number of events 42 • All-cause mortality and adverse events (AEs): up to approximately 4 years and 11 months
All-cause mortality is reported for all randomized participants; Serious and other AEs include participants who received at least one dose of study drug. AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
|
Infections and infestations
Nasopharyngitis
|
3.5%
9/255 • Number of events 14 • All-cause mortality and adverse events (AEs): up to approximately 4 years and 11 months
All-cause mortality is reported for all randomized participants; Serious and other AEs include participants who received at least one dose of study drug. AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
2.5%
6/240 • Number of events 7 • All-cause mortality and adverse events (AEs): up to approximately 4 years and 11 months
All-cause mortality is reported for all randomized participants; Serious and other AEs include participants who received at least one dose of study drug. AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
|
Infections and infestations
Pneumonia
|
11.0%
28/255 • Number of events 31 • All-cause mortality and adverse events (AEs): up to approximately 4 years and 11 months
All-cause mortality is reported for all randomized participants; Serious and other AEs include participants who received at least one dose of study drug. AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
5.8%
14/240 • Number of events 17 • All-cause mortality and adverse events (AEs): up to approximately 4 years and 11 months
All-cause mortality is reported for all randomized participants; Serious and other AEs include participants who received at least one dose of study drug. AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
|
Infections and infestations
Upper respiratory tract infection
|
3.1%
8/255 • Number of events 11 • All-cause mortality and adverse events (AEs): up to approximately 4 years and 11 months
All-cause mortality is reported for all randomized participants; Serious and other AEs include participants who received at least one dose of study drug. AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
4.6%
11/240 • Number of events 11 • All-cause mortality and adverse events (AEs): up to approximately 4 years and 11 months
All-cause mortality is reported for all randomized participants; Serious and other AEs include participants who received at least one dose of study drug. AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
|
Investigations
Alanine aminotransferase increased
|
12.9%
33/255 • Number of events 49 • All-cause mortality and adverse events (AEs): up to approximately 4 years and 11 months
All-cause mortality is reported for all randomized participants; Serious and other AEs include participants who received at least one dose of study drug. AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
7.9%
19/240 • Number of events 22 • All-cause mortality and adverse events (AEs): up to approximately 4 years and 11 months
All-cause mortality is reported for all randomized participants; Serious and other AEs include participants who received at least one dose of study drug. AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
|
Investigations
Aspartate aminotransferase increased
|
14.5%
37/255 • Number of events 55 • All-cause mortality and adverse events (AEs): up to approximately 4 years and 11 months
All-cause mortality is reported for all randomized participants; Serious and other AEs include participants who received at least one dose of study drug. AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
4.6%
11/240 • Number of events 13 • All-cause mortality and adverse events (AEs): up to approximately 4 years and 11 months
All-cause mortality is reported for all randomized participants; Serious and other AEs include participants who received at least one dose of study drug. AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
|
Investigations
Blood alkaline phosphatase increased
|
6.7%
17/255 • Number of events 26 • All-cause mortality and adverse events (AEs): up to approximately 4 years and 11 months
All-cause mortality is reported for all randomized participants; Serious and other AEs include participants who received at least one dose of study drug. AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
2.1%
5/240 • Number of events 10 • All-cause mortality and adverse events (AEs): up to approximately 4 years and 11 months
All-cause mortality is reported for all randomized participants; Serious and other AEs include participants who received at least one dose of study drug. AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
|
Investigations
Blood bilirubin increased
|
3.5%
9/255 • Number of events 16 • All-cause mortality and adverse events (AEs): up to approximately 4 years and 11 months
All-cause mortality is reported for all randomized participants; Serious and other AEs include participants who received at least one dose of study drug. AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
2.5%
6/240 • Number of events 11 • All-cause mortality and adverse events (AEs): up to approximately 4 years and 11 months
All-cause mortality is reported for all randomized participants; Serious and other AEs include participants who received at least one dose of study drug. AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
|
Investigations
Blood creatine phosphokinase MB increased
|
4.3%
11/255 • Number of events 14 • All-cause mortality and adverse events (AEs): up to approximately 4 years and 11 months
All-cause mortality is reported for all randomized participants; Serious and other AEs include participants who received at least one dose of study drug. AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
0.42%
1/240 • Number of events 1 • All-cause mortality and adverse events (AEs): up to approximately 4 years and 11 months
All-cause mortality is reported for all randomized participants; Serious and other AEs include participants who received at least one dose of study drug. AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
|
Investigations
Blood creatine phosphokinase increased
|
3.9%
10/255 • Number of events 15 • All-cause mortality and adverse events (AEs): up to approximately 4 years and 11 months
All-cause mortality is reported for all randomized participants; Serious and other AEs include participants who received at least one dose of study drug. AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
0.00%
0/240 • All-cause mortality and adverse events (AEs): up to approximately 4 years and 11 months
All-cause mortality is reported for all randomized participants; Serious and other AEs include participants who received at least one dose of study drug. AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
|
Investigations
C-reactive protein increased
|
3.1%
8/255 • Number of events 8 • All-cause mortality and adverse events (AEs): up to approximately 4 years and 11 months
All-cause mortality is reported for all randomized participants; Serious and other AEs include participants who received at least one dose of study drug. AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
0.83%
2/240 • Number of events 2 • All-cause mortality and adverse events (AEs): up to approximately 4 years and 11 months
All-cause mortality is reported for all randomized participants; Serious and other AEs include participants who received at least one dose of study drug. AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
|
Investigations
Gamma-glutamyltransferase increased
|
5.5%
14/255 • Number of events 23 • All-cause mortality and adverse events (AEs): up to approximately 4 years and 11 months
All-cause mortality is reported for all randomized participants; Serious and other AEs include participants who received at least one dose of study drug. AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
3.3%
8/240 • Number of events 10 • All-cause mortality and adverse events (AEs): up to approximately 4 years and 11 months
All-cause mortality is reported for all randomized participants; Serious and other AEs include participants who received at least one dose of study drug. AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
|
Investigations
Lymphocyte count decreased
|
4.7%
12/255 • Number of events 21 • All-cause mortality and adverse events (AEs): up to approximately 4 years and 11 months
All-cause mortality is reported for all randomized participants; Serious and other AEs include participants who received at least one dose of study drug. AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
9.2%
22/240 • Number of events 36 • All-cause mortality and adverse events (AEs): up to approximately 4 years and 11 months
All-cause mortality is reported for all randomized participants; Serious and other AEs include participants who received at least one dose of study drug. AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
|
Investigations
Neutrophil count decreased
|
2.4%
6/255 • Number of events 19 • All-cause mortality and adverse events (AEs): up to approximately 4 years and 11 months
All-cause mortality is reported for all randomized participants; Serious and other AEs include participants who received at least one dose of study drug. AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
36.7%
88/240 • Number of events 202 • All-cause mortality and adverse events (AEs): up to approximately 4 years and 11 months
All-cause mortality is reported for all randomized participants; Serious and other AEs include participants who received at least one dose of study drug. AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
|
Investigations
Platelet count decreased
|
5.5%
14/255 • Number of events 23 • All-cause mortality and adverse events (AEs): up to approximately 4 years and 11 months
All-cause mortality is reported for all randomized participants; Serious and other AEs include participants who received at least one dose of study drug. AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
6.7%
16/240 • Number of events 20 • All-cause mortality and adverse events (AEs): up to approximately 4 years and 11 months
All-cause mortality is reported for all randomized participants; Serious and other AEs include participants who received at least one dose of study drug. AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
|
Investigations
Weight decreased
|
24.3%
62/255 • Number of events 101 • All-cause mortality and adverse events (AEs): up to approximately 4 years and 11 months
All-cause mortality is reported for all randomized participants; Serious and other AEs include participants who received at least one dose of study drug. AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
18.8%
45/240 • Number of events 55 • All-cause mortality and adverse events (AEs): up to approximately 4 years and 11 months
All-cause mortality is reported for all randomized participants; Serious and other AEs include participants who received at least one dose of study drug. AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
|
Investigations
White blood cell count decreased
|
4.3%
11/255 • Number of events 25 • All-cause mortality and adverse events (AEs): up to approximately 4 years and 11 months
All-cause mortality is reported for all randomized participants; Serious and other AEs include participants who received at least one dose of study drug. AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
39.6%
95/240 • Number of events 227 • All-cause mortality and adverse events (AEs): up to approximately 4 years and 11 months
All-cause mortality is reported for all randomized participants; Serious and other AEs include participants who received at least one dose of study drug. AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
|
Investigations
White blood cell count increased
|
4.7%
12/255 • Number of events 17 • All-cause mortality and adverse events (AEs): up to approximately 4 years and 11 months
All-cause mortality is reported for all randomized participants; Serious and other AEs include participants who received at least one dose of study drug. AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
2.5%
6/240 • Number of events 8 • All-cause mortality and adverse events (AEs): up to approximately 4 years and 11 months
All-cause mortality is reported for all randomized participants; Serious and other AEs include participants who received at least one dose of study drug. AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
16.5%
42/255 • Number of events 53 • All-cause mortality and adverse events (AEs): up to approximately 4 years and 11 months
All-cause mortality is reported for all randomized participants; Serious and other AEs include participants who received at least one dose of study drug. AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
33.3%
80/240 • Number of events 102 • All-cause mortality and adverse events (AEs): up to approximately 4 years and 11 months
All-cause mortality is reported for all randomized participants; Serious and other AEs include participants who received at least one dose of study drug. AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
6.7%
17/255 • Number of events 35 • All-cause mortality and adverse events (AEs): up to approximately 4 years and 11 months
All-cause mortality is reported for all randomized participants; Serious and other AEs include participants who received at least one dose of study drug. AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
3.3%
8/240 • Number of events 8 • All-cause mortality and adverse events (AEs): up to approximately 4 years and 11 months
All-cause mortality is reported for all randomized participants; Serious and other AEs include participants who received at least one dose of study drug. AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
3.1%
8/255 • Number of events 13 • All-cause mortality and adverse events (AEs): up to approximately 4 years and 11 months
All-cause mortality is reported for all randomized participants; Serious and other AEs include participants who received at least one dose of study drug. AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
0.83%
2/240 • Number of events 3 • All-cause mortality and adverse events (AEs): up to approximately 4 years and 11 months
All-cause mortality is reported for all randomized participants; Serious and other AEs include participants who received at least one dose of study drug. AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
|
Metabolism and nutrition disorders
Hyperuricaemia
|
2.4%
6/255 • Number of events 13 • All-cause mortality and adverse events (AEs): up to approximately 4 years and 11 months
All-cause mortality is reported for all randomized participants; Serious and other AEs include participants who received at least one dose of study drug. AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
4.6%
11/240 • Number of events 19 • All-cause mortality and adverse events (AEs): up to approximately 4 years and 11 months
All-cause mortality is reported for all randomized participants; Serious and other AEs include participants who received at least one dose of study drug. AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
14.1%
36/255 • Number of events 51 • All-cause mortality and adverse events (AEs): up to approximately 4 years and 11 months
All-cause mortality is reported for all randomized participants; Serious and other AEs include participants who received at least one dose of study drug. AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
12.5%
30/240 • Number of events 44 • All-cause mortality and adverse events (AEs): up to approximately 4 years and 11 months
All-cause mortality is reported for all randomized participants; Serious and other AEs include participants who received at least one dose of study drug. AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
3.1%
8/255 • Number of events 11 • All-cause mortality and adverse events (AEs): up to approximately 4 years and 11 months
All-cause mortality is reported for all randomized participants; Serious and other AEs include participants who received at least one dose of study drug. AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
4.6%
11/240 • Number of events 17 • All-cause mortality and adverse events (AEs): up to approximately 4 years and 11 months
All-cause mortality is reported for all randomized participants; Serious and other AEs include participants who received at least one dose of study drug. AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
|
Metabolism and nutrition disorders
Hypochloraemia
|
2.4%
6/255 • Number of events 10 • All-cause mortality and adverse events (AEs): up to approximately 4 years and 11 months
All-cause mortality is reported for all randomized participants; Serious and other AEs include participants who received at least one dose of study drug. AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
4.2%
10/240 • Number of events 13 • All-cause mortality and adverse events (AEs): up to approximately 4 years and 11 months
All-cause mortality is reported for all randomized participants; Serious and other AEs include participants who received at least one dose of study drug. AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
3.1%
8/255 • Number of events 11 • All-cause mortality and adverse events (AEs): up to approximately 4 years and 11 months
All-cause mortality is reported for all randomized participants; Serious and other AEs include participants who received at least one dose of study drug. AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
1.2%
3/240 • Number of events 4 • All-cause mortality and adverse events (AEs): up to approximately 4 years and 11 months
All-cause mortality is reported for all randomized participants; Serious and other AEs include participants who received at least one dose of study drug. AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
8.6%
22/255 • Number of events 23 • All-cause mortality and adverse events (AEs): up to approximately 4 years and 11 months
All-cause mortality is reported for all randomized participants; Serious and other AEs include participants who received at least one dose of study drug. AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
9.2%
22/240 • Number of events 42 • All-cause mortality and adverse events (AEs): up to approximately 4 years and 11 months
All-cause mortality is reported for all randomized participants; Serious and other AEs include participants who received at least one dose of study drug. AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
12.2%
31/255 • Number of events 56 • All-cause mortality and adverse events (AEs): up to approximately 4 years and 11 months
All-cause mortality is reported for all randomized participants; Serious and other AEs include participants who received at least one dose of study drug. AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
13.8%
33/240 • Number of events 45 • All-cause mortality and adverse events (AEs): up to approximately 4 years and 11 months
All-cause mortality is reported for all randomized participants; Serious and other AEs include participants who received at least one dose of study drug. AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
|
Metabolism and nutrition disorders
Hypoproteinaemia
|
5.1%
13/255 • Number of events 14 • All-cause mortality and adverse events (AEs): up to approximately 4 years and 11 months
All-cause mortality is reported for all randomized participants; Serious and other AEs include participants who received at least one dose of study drug. AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
3.3%
8/240 • Number of events 10 • All-cause mortality and adverse events (AEs): up to approximately 4 years and 11 months
All-cause mortality is reported for all randomized participants; Serious and other AEs include participants who received at least one dose of study drug. AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
8.6%
22/255 • Number of events 25 • All-cause mortality and adverse events (AEs): up to approximately 4 years and 11 months
All-cause mortality is reported for all randomized participants; Serious and other AEs include participants who received at least one dose of study drug. AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
7.5%
18/240 • Number of events 24 • All-cause mortality and adverse events (AEs): up to approximately 4 years and 11 months
All-cause mortality is reported for all randomized participants; Serious and other AEs include participants who received at least one dose of study drug. AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
11.0%
28/255 • Number of events 32 • All-cause mortality and adverse events (AEs): up to approximately 4 years and 11 months
All-cause mortality is reported for all randomized participants; Serious and other AEs include participants who received at least one dose of study drug. AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
7.1%
17/240 • Number of events 27 • All-cause mortality and adverse events (AEs): up to approximately 4 years and 11 months
All-cause mortality is reported for all randomized participants; Serious and other AEs include participants who received at least one dose of study drug. AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
3.1%
8/255 • Number of events 9 • All-cause mortality and adverse events (AEs): up to approximately 4 years and 11 months
All-cause mortality is reported for all randomized participants; Serious and other AEs include participants who received at least one dose of study drug. AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
5.8%
14/240 • Number of events 26 • All-cause mortality and adverse events (AEs): up to approximately 4 years and 11 months
All-cause mortality is reported for all randomized participants; Serious and other AEs include participants who received at least one dose of study drug. AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cancer pain
|
3.9%
10/255 • Number of events 12 • All-cause mortality and adverse events (AEs): up to approximately 4 years and 11 months
All-cause mortality is reported for all randomized participants; Serious and other AEs include participants who received at least one dose of study drug. AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
1.2%
3/240 • Number of events 4 • All-cause mortality and adverse events (AEs): up to approximately 4 years and 11 months
All-cause mortality is reported for all randomized participants; Serious and other AEs include participants who received at least one dose of study drug. AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
|
Nervous system disorders
Dizziness
|
4.3%
11/255 • Number of events 13 • All-cause mortality and adverse events (AEs): up to approximately 4 years and 11 months
All-cause mortality is reported for all randomized participants; Serious and other AEs include participants who received at least one dose of study drug. AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
7.9%
19/240 • Number of events 26 • All-cause mortality and adverse events (AEs): up to approximately 4 years and 11 months
All-cause mortality is reported for all randomized participants; Serious and other AEs include participants who received at least one dose of study drug. AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
0.78%
2/255 • Number of events 3 • All-cause mortality and adverse events (AEs): up to approximately 4 years and 11 months
All-cause mortality is reported for all randomized participants; Serious and other AEs include participants who received at least one dose of study drug. AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
9.6%
23/240 • Number of events 36 • All-cause mortality and adverse events (AEs): up to approximately 4 years and 11 months
All-cause mortality is reported for all randomized participants; Serious and other AEs include participants who received at least one dose of study drug. AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
|
Psychiatric disorders
Insomnia
|
8.2%
21/255 • Number of events 24 • All-cause mortality and adverse events (AEs): up to approximately 4 years and 11 months
All-cause mortality is reported for all randomized participants; Serious and other AEs include participants who received at least one dose of study drug. AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
7.1%
17/240 • Number of events 23 • All-cause mortality and adverse events (AEs): up to approximately 4 years and 11 months
All-cause mortality is reported for all randomized participants; Serious and other AEs include participants who received at least one dose of study drug. AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
17.3%
44/255 • Number of events 56 • All-cause mortality and adverse events (AEs): up to approximately 4 years and 11 months
All-cause mortality is reported for all randomized participants; Serious and other AEs include participants who received at least one dose of study drug. AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
11.7%
28/240 • Number of events 30 • All-cause mortality and adverse events (AEs): up to approximately 4 years and 11 months
All-cause mortality is reported for all randomized participants; Serious and other AEs include participants who received at least one dose of study drug. AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
3.1%
8/255 • Number of events 8 • All-cause mortality and adverse events (AEs): up to approximately 4 years and 11 months
All-cause mortality is reported for all randomized participants; Serious and other AEs include participants who received at least one dose of study drug. AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
0.83%
2/240 • Number of events 2 • All-cause mortality and adverse events (AEs): up to approximately 4 years and 11 months
All-cause mortality is reported for all randomized participants; Serious and other AEs include participants who received at least one dose of study drug. AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
9.8%
25/255 • Number of events 29 • All-cause mortality and adverse events (AEs): up to approximately 4 years and 11 months
All-cause mortality is reported for all randomized participants; Serious and other AEs include participants who received at least one dose of study drug. AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
7.9%
19/240 • Number of events 23 • All-cause mortality and adverse events (AEs): up to approximately 4 years and 11 months
All-cause mortality is reported for all randomized participants; Serious and other AEs include participants who received at least one dose of study drug. AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
3.9%
10/255 • Number of events 11 • All-cause mortality and adverse events (AEs): up to approximately 4 years and 11 months
All-cause mortality is reported for all randomized participants; Serious and other AEs include participants who received at least one dose of study drug. AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
2.1%
5/240 • Number of events 7 • All-cause mortality and adverse events (AEs): up to approximately 4 years and 11 months
All-cause mortality is reported for all randomized participants; Serious and other AEs include participants who received at least one dose of study drug. AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
3.9%
10/255 • Number of events 12 • All-cause mortality and adverse events (AEs): up to approximately 4 years and 11 months
All-cause mortality is reported for all randomized participants; Serious and other AEs include participants who received at least one dose of study drug. AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
0.83%
2/240 • Number of events 2 • All-cause mortality and adverse events (AEs): up to approximately 4 years and 11 months
All-cause mortality is reported for all randomized participants; Serious and other AEs include participants who received at least one dose of study drug. AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
7.1%
18/255 • Number of events 21 • All-cause mortality and adverse events (AEs): up to approximately 4 years and 11 months
All-cause mortality is reported for all randomized participants; Serious and other AEs include participants who received at least one dose of study drug. AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
7.5%
18/240 • Number of events 19 • All-cause mortality and adverse events (AEs): up to approximately 4 years and 11 months
All-cause mortality is reported for all randomized participants; Serious and other AEs include participants who received at least one dose of study drug. AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
0.39%
1/255 • Number of events 1 • All-cause mortality and adverse events (AEs): up to approximately 4 years and 11 months
All-cause mortality is reported for all randomized participants; Serious and other AEs include participants who received at least one dose of study drug. AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
17.5%
42/240 • Number of events 46 • All-cause mortality and adverse events (AEs): up to approximately 4 years and 11 months
All-cause mortality is reported for all randomized participants; Serious and other AEs include participants who received at least one dose of study drug. AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
9.8%
25/255 • Number of events 34 • All-cause mortality and adverse events (AEs): up to approximately 4 years and 11 months
All-cause mortality is reported for all randomized participants; Serious and other AEs include participants who received at least one dose of study drug. AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
4.6%
11/240 • Number of events 13 • All-cause mortality and adverse events (AEs): up to approximately 4 years and 11 months
All-cause mortality is reported for all randomized participants; Serious and other AEs include participants who received at least one dose of study drug. AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
|
Skin and subcutaneous tissue disorders
Rash
|
9.0%
23/255 • Number of events 31 • All-cause mortality and adverse events (AEs): up to approximately 4 years and 11 months
All-cause mortality is reported for all randomized participants; Serious and other AEs include participants who received at least one dose of study drug. AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
4.2%
10/240 • Number of events 10 • All-cause mortality and adverse events (AEs): up to approximately 4 years and 11 months
All-cause mortality is reported for all randomized participants; Serious and other AEs include participants who received at least one dose of study drug. AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
|
Vascular disorders
Hypertension
|
5.1%
13/255 • Number of events 32 • All-cause mortality and adverse events (AEs): up to approximately 4 years and 11 months
All-cause mortality is reported for all randomized participants; Serious and other AEs include participants who received at least one dose of study drug. AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
2.5%
6/240 • Number of events 15 • All-cause mortality and adverse events (AEs): up to approximately 4 years and 11 months
All-cause mortality is reported for all randomized participants; Serious and other AEs include participants who received at least one dose of study drug. AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
|
Vascular disorders
Hypotension
|
3.9%
10/255 • Number of events 14 • All-cause mortality and adverse events (AEs): up to approximately 4 years and 11 months
All-cause mortality is reported for all randomized participants; Serious and other AEs include participants who received at least one dose of study drug. AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
2.5%
6/240 • Number of events 8 • All-cause mortality and adverse events (AEs): up to approximately 4 years and 11 months
All-cause mortality is reported for all randomized participants; Serious and other AEs include participants who received at least one dose of study drug. AEs are defined as events that had an onset date or a worsening in severity from baseline (pretreatment) on or after the first dose of study treatment up to 30 days following study treatment discontinuation or initiation of a new anticancer therapy, whichever occurred first.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee BeiGene has 18 months from the end of the study at all sites to publish overall study results. After the 1st multi-site publication or the expiration of publication period, Investigators are free to publish/present the results of the study. Investigators must submit all draft publications/presentations to us for review 60 days prior to the planned publication/presentation date. BeiGene may request deletion of its confidential information \& may request a further delay to protect its IP rights.
- Publication restrictions are in place
Restriction type: OTHER