Trial Outcomes & Findings for Study of BGB-A317 in Participants With Previously Treated Unresectable HCC (NCT NCT03419897)
NCT ID: NCT03419897
Last Updated: 2024-10-26
Results Overview
ORR is defined as the percentage of participants with complete response (CR) and partial response (PR) as the best overall response, as determined by an IRC using Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. CR is defined as disappearance of all target lesions and PR is defined as at least a 30% decrease in the sum of diameters of target lesions.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
249 participants
Primary outcome timeframe
From date of first dose to primary analysis data cut-off date of 30-June-2021 (up to approximately 3 years and 3 months)
Results posted on
2024-10-26
Participant Flow
This study was conducted at 73 study centers in Mainland China, Taiwan, Italy, Germany, France, Spain, Poland, and the United Kingdom.
Participant milestones
| Measure |
Tislelizumab
Tislelizumab 200 milligrams (mg) administered intravenously once every 3 weeks until unacceptable toxicity, withdrawal of consent, or the time point at which the participant was no longer benefiting from therapy, as assessed by the investigator, whichever occurred first
|
|---|---|
|
Overall Study
STARTED
|
249
|
|
Overall Study
COMPLETED
|
0
|
|
Overall Study
NOT COMPLETED
|
249
|
Reasons for withdrawal
| Measure |
Tislelizumab
Tislelizumab 200 milligrams (mg) administered intravenously once every 3 weeks until unacceptable toxicity, withdrawal of consent, or the time point at which the participant was no longer benefiting from therapy, as assessed by the investigator, whichever occurred first
|
|---|---|
|
Overall Study
Death
|
180
|
|
Overall Study
Lost to Follow-up
|
1
|
|
Overall Study
Withdrawal by Subject
|
6
|
|
Overall Study
Sponsor Decision
|
61
|
|
Overall Study
Physician Decision
|
1
|
Baseline Characteristics
Study of BGB-A317 in Participants With Previously Treated Unresectable HCC
Baseline characteristics by cohort
| Measure |
Tislelizumab
n=249 Participants
Tislelizumab 200 mg administered intravenously once every 3 weeks until unacceptable toxicity, withdrawal of consent, or the time point at which the participant was no longer benefiting from therapy, as assessed by the investigator, whichever occurred first
|
|---|---|
|
Age, Continuous
|
60.3 Years
STANDARD_DEVIATION 12.54 • n=5 Participants
|
|
Sex: Female, Male
Female
|
32 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
217 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
123 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
47 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other
|
1 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Not Reported
|
78 Participants
n=5 Participants
|
|
Eastern Cooperative Oncology Group (ECOG) Performance Status Score
0 = Fully Active
|
129 Participants
n=5 Participants
|
|
Eastern Cooperative Oncology Group (ECOG) Performance Status Score
1 = Restricted Activity
|
120 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: From date of first dose to primary analysis data cut-off date of 30-June-2021 (up to approximately 3 years and 3 months)Population: Safety analysis set included all participants who received ≥ 1 dose of study drug
ORR is defined as the percentage of participants with complete response (CR) and partial response (PR) as the best overall response, as determined by an IRC using Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. CR is defined as disappearance of all target lesions and PR is defined as at least a 30% decrease in the sum of diameters of target lesions.
Outcome measures
| Measure |
Tislelizumab
n=249 Participants
Tislelizumab 200 mg administered intravenously once every 3 weeks until unacceptable toxicity, withdrawal of consent, or the time point at which the participant was no longer benefiting from therapy, as assessed by the investigator, whichever occurred first
|
|---|---|
|
Objective Response Rate (ORR) Assessed by Independent Review Committee (IRC)
|
12.9 Percentage of participants
Interval 8.96 to 17.66
|
SECONDARY outcome
Timeframe: From date of first dose to end of study (up to approximately 4 years and 3 months)Population: Safety analysis set included all participants who received ≥ 1 dose of study drug
ORR is defined as the percentage of participants with CR and PR as the best overall response, as determined by investigator assessment using RECIST v1.1. CR is defined as disappearance of all target lesions and PR is defined as at least a 30% decrease in the sum of diameters of target lesions.
Outcome measures
| Measure |
Tislelizumab
n=249 Participants
Tislelizumab 200 mg administered intravenously once every 3 weeks until unacceptable toxicity, withdrawal of consent, or the time point at which the participant was no longer benefiting from therapy, as assessed by the investigator, whichever occurred first
|
|---|---|
|
ORR Assessed by Investigator
|
14.5 Percentage of participants
Interval 10.34 to 19.45
|
SECONDARY outcome
Timeframe: From date of first dose to end of study (up to approximately 4 years and 3 months)Population: Safety analysis set included all participants who received ≥ 1 dose of study drug
DOR is defined as the time from the date that response criteria are first met to the date that progressive disease is objectively documented or death, whichever comes first, as assessed by the IRC using RECIST v1.1
Outcome measures
| Measure |
Tislelizumab
n=249 Participants
Tislelizumab 200 mg administered intravenously once every 3 weeks until unacceptable toxicity, withdrawal of consent, or the time point at which the participant was no longer benefiting from therapy, as assessed by the investigator, whichever occurred first
|
|---|---|
|
Duration of Response (DOR) Assessed by IRC
|
NA Months
Interval 14.6 to
Median DOR was not reached, and confidence interval data is not estimable due to insufficient number of participants with events
|
SECONDARY outcome
Timeframe: From date of first dose to end of study (up to approximately 4 years and 3 months); Months 12 and 24 reportedPopulation: Safety analysis set included all participants who received ≥ 1 dose of study drug
DOR is defined as the time from the date that response criteria are first met to the date that progressive disease is objectively documented or death, whichever comes first, as assessed by the IRC using RECIST v1.1. The Kaplan-Meier method was used to estimate the percentage of participants who were event-free for progression or death at 12 and 24 months with 95% confidence intervals estimated using Greenwood's formula.
Outcome measures
| Measure |
Tislelizumab
n=249 Participants
Tislelizumab 200 mg administered intravenously once every 3 weeks until unacceptable toxicity, withdrawal of consent, or the time point at which the participant was no longer benefiting from therapy, as assessed by the investigator, whichever occurred first
|
|---|---|
|
DOR Event-Free Rate Assessed by IRC
12 Months
|
76.9 Percentage of participants
Interval 57.5 to 88.3
|
|
DOR Event-Free Rate Assessed by IRC
24 Months
|
65.9 Percentage of participants
Interval 45.7 to 80.1
|
SECONDARY outcome
Timeframe: From date of first dose to end of study (up to approximately 4 years and 3 months)Population: Safety analysis set included all participants who received ≥ 1 dose of study drug
DOR is defined as the time from the date that response criteria are first met to the date that progressive disease is objectively documented or death, whichever comes first, as assessed by the investigator using RECIST v1.1
Outcome measures
| Measure |
Tislelizumab
n=249 Participants
Tislelizumab 200 mg administered intravenously once every 3 weeks until unacceptable toxicity, withdrawal of consent, or the time point at which the participant was no longer benefiting from therapy, as assessed by the investigator, whichever occurred first
|
|---|---|
|
DOR Assessed by Investigator
|
21.4 Months
Interval 11.1 to
Not estimable due to insufficient number of participants with events
|
SECONDARY outcome
Timeframe: From date of first dose to end of study (up to approximately 4 years and 3 months); Months 12 and 24 reportedPopulation: Safety analysis set included all participants who received ≥ 1 dose of study drug
DOR is defined as the time from the date that response criteria are first met to the date that progressive disease is objectively documented or death, whichever comes first, as assessed by the investigator using RECIST v1.1. The Kaplan-Meier method was used to estimate the percentage of participants who were event-free for progression or death at 12 and 24 months with 95% confidence intervals estimated using Greenwood's formula.
Outcome measures
| Measure |
Tislelizumab
n=249 Participants
Tislelizumab 200 mg administered intravenously once every 3 weeks until unacceptable toxicity, withdrawal of consent, or the time point at which the participant was no longer benefiting from therapy, as assessed by the investigator, whichever occurred first
|
|---|---|
|
DOR Event-Free Rate Assessed by Investigator
12 Months
|
68.1 Percentage of participants
Interval 49.8 to 80.9
|
|
DOR Event-Free Rate Assessed by Investigator
24 Months
|
47.4 Percentage of participants
Interval 30.1 to 62.8
|
SECONDARY outcome
Timeframe: From date of first dose to end of study (up to approximately 4 years and 3 months)Population: Safety analysis set included all participants who received ≥ 1 dose of study drug
PFS is defined as the time from first dose until first documentation of progression or death, whichever comes first, as assessed by the IRC using RECIST v1.1
Outcome measures
| Measure |
Tislelizumab
n=249 Participants
Tislelizumab 200 mg administered intravenously once every 3 weeks until unacceptable toxicity, withdrawal of consent, or the time point at which the participant was no longer benefiting from therapy, as assessed by the investigator, whichever occurred first
|
|---|---|
|
Progression-free Survival (PFS) Assessed by IRC
|
2.7 Months
Interval 1.4 to 2.8
|
SECONDARY outcome
Timeframe: From date of first dose to end of study (up to approximately 4 years and 3 months)Population: Safety analysis set included all participants who received ≥ 1 dose of study drug
PFS is defined as the time from first dose until first documentation of progression or death, whichever comes first, as assessed by the investigator using RECIST v1.1
Outcome measures
| Measure |
Tislelizumab
n=249 Participants
Tislelizumab 200 mg administered intravenously once every 3 weeks until unacceptable toxicity, withdrawal of consent, or the time point at which the participant was no longer benefiting from therapy, as assessed by the investigator, whichever occurred first
|
|---|---|
|
PFS Assessed by Investigator
|
2.8 Months
Interval 2.6 to 4.0
|
SECONDARY outcome
Timeframe: From date of first dose to end of study (up to approximately 4 years and 3 months)Population: Safety analysis set included all participants who received ≥ 1 dose of study drug
OS is defined as the time from first study drug administration to the date of death due to any cause
Outcome measures
| Measure |
Tislelizumab
n=249 Participants
Tislelizumab 200 mg administered intravenously once every 3 weeks until unacceptable toxicity, withdrawal of consent, or the time point at which the participant was no longer benefiting from therapy, as assessed by the investigator, whichever occurred first
|
|---|---|
|
Overall Survival (OS)
|
13.2 Months
Interval 10.8 to 15.2
|
SECONDARY outcome
Timeframe: From date of first dose to end of study (up to approximately 4 years and 3 months)Population: Safety analysis set included all participants who received ≥ 1 dose of study drug
DCR is defined as the percentage of participants whose best overall response is CR, PR, or stable disease (SD) as assessed by the IRC using RECIST v1.1
Outcome measures
| Measure |
Tislelizumab
n=249 Participants
Tislelizumab 200 mg administered intravenously once every 3 weeks until unacceptable toxicity, withdrawal of consent, or the time point at which the participant was no longer benefiting from therapy, as assessed by the investigator, whichever occurred first
|
|---|---|
|
Disease Control Rate (DCR) Assessed by IRC
|
53.0 Percentage of participants
Interval 46.61 to 59.34
|
SECONDARY outcome
Timeframe: From date of first dose to end of study (up to approximately 4 years and 3 months)Population: Safety analysis set included all participants who received ≥ 1 dose of study drug
DCR is defined as the percentage of participants whose best overall response is CR, PR, or stable disease (SD) as assessed by the investigator using RECIST v1.1
Outcome measures
| Measure |
Tislelizumab
n=249 Participants
Tislelizumab 200 mg administered intravenously once every 3 weeks until unacceptable toxicity, withdrawal of consent, or the time point at which the participant was no longer benefiting from therapy, as assessed by the investigator, whichever occurred first
|
|---|---|
|
DCR Assessed by Investigator
|
59.0 Percentage of participants
Interval 52.65 to 65.2
|
SECONDARY outcome
Timeframe: From date of first dose to end of study (up to approximately 4 years and 3 months)Population: Safety analysis set included all participants who received ≥ 1 dose of study drug
CBR is defined as the percentage of participants who have CR, PR, or SD of ≥ 24 weeks in duration as assessed by the IRC using RECIST v1.1
Outcome measures
| Measure |
Tislelizumab
n=249 Participants
Tislelizumab 200 mg administered intravenously once every 3 weeks until unacceptable toxicity, withdrawal of consent, or the time point at which the participant was no longer benefiting from therapy, as assessed by the investigator, whichever occurred first
|
|---|---|
|
Clinical Benefit Rate (CBR) Assessed by IRC
|
22.5 Percentage of participants
Interval 17.46 to 28.19
|
SECONDARY outcome
Timeframe: From date of first dose to end of study (up to approximately 4 years and 3 months)Population: Safety analysis set included all participants who received ≥ 1 dose of study drug
CBR is defined as the percentage of participants who have CR, PR, or SD of ≥ 24 weeks in duration as assessed by the investigator using RECIST v1.1
Outcome measures
| Measure |
Tislelizumab
n=249 Participants
Tislelizumab 200 mg administered intravenously once every 3 weeks until unacceptable toxicity, withdrawal of consent, or the time point at which the participant was no longer benefiting from therapy, as assessed by the investigator, whichever occurred first
|
|---|---|
|
CBR Assessed by Investigator
|
30.9 Percentage of participants
Interval 25.24 to 37.07
|
SECONDARY outcome
Timeframe: Baseline to Cycle 6 Day 1 and Cycle 12 Day 1 (each cycle is 21 days)Population: Safety analysis set included all participants who received ≥ 1 dose of study drug; "Overall number of participants analyzed" refers to number of participants evaluable for this outcome measure and "Number analyzed" refers to participants evaluable at specified time points.
Mean change from baseline in EQ-5D-5L 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=202 Participants
Tislelizumab 200 mg administered intravenously once every 3 weeks until unacceptable toxicity, withdrawal of consent, or the time point at which the participant was no longer benefiting from therapy, as assessed by the investigator, whichever occurred first
|
|---|---|
|
European Quality of Life 5 Dimensions 5 Level Version (EQ-5D-5L) Visual Analogue Score (VAS)
Baseline
|
75.2 Score on a scale
Standard Deviation 18.36
|
|
European Quality of Life 5 Dimensions 5 Level Version (EQ-5D-5L) Visual Analogue Score (VAS)
Change at Cycle 6
|
2.4 Score on a scale
Standard Deviation 12.57
|
|
European Quality of Life 5 Dimensions 5 Level Version (EQ-5D-5L) Visual Analogue Score (VAS)
Change at Cycle 12
|
4.7 Score on a scale
Standard Deviation 13.85
|
SECONDARY outcome
Timeframe: Baseline to Cycle 6 Day 1 and Cycle 12 Day 1 (each cycle is 21 days)Population: Safety analysis set included all participants who received ≥ 1 dose of study drug; "Overall number of participants analyzed" refers to number of participants evaluable for this outcome measure and "Number analyzed" refers to participants evaluable at specified time points.
Mean change from baseline in EORTC QLQ-C30 Global Health Status/Quality of Life score. The EORTC QLQ-C30 v3.0 is a questionnaire that assesses quality of life of cancer patients. 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=238 Participants
Tislelizumab 200 mg administered intravenously once every 3 weeks until unacceptable toxicity, withdrawal of consent, or the time point at which the participant was no longer benefiting from therapy, as assessed by the investigator, whichever occurred first
|
|---|---|
|
European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) Global Health Status
Baseline
|
71.8 Score on a scale
Standard Deviation 19.37
|
|
European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) Global Health Status
Change at Cycle 6
|
-0.1 Score on a scale
Standard Deviation 17.50
|
|
European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) Global Health Status
Change at Cycle 12
|
1.1 Score on a scale
Standard Deviation 18.63
|
SECONDARY outcome
Timeframe: Baseline to Cycle 6 Day 1 and Cycle 12 Day 1 (each cycle is 21 days)Population: Safety analysis set included all participants who received ≥ 1 dose of study drug; "Overall number of participants analyzed" refers to number of participants evaluable for this outcome measure and "Number analyzed" refers to participants evaluable at specified time points.
Mean change from baseline in EORTC QLQ HCC18 Index Scores. The EORTC QLQ HCC18 is a specific questionnaire module that assesses quality of life of cancer patients 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=236 Participants
Tislelizumab 200 mg administered intravenously once every 3 weeks until unacceptable toxicity, withdrawal of consent, or the time point at which the participant was no longer benefiting from therapy, as assessed by the investigator, whichever occurred first
|
|---|---|
|
EORTC QLQ - Hepatocellular Carcinoma 18 Questions (HCC18): Index Scores
Baseline
|
13.6 Score on a scale
Standard Deviation 11.33
|
|
EORTC QLQ - Hepatocellular Carcinoma 18 Questions (HCC18): Index Scores
Change at Cycle 6
|
1.4 Score on a scale
Standard Deviation 11.77
|
|
EORTC QLQ - Hepatocellular Carcinoma 18 Questions (HCC18): Index Scores
Change at Cycle 12
|
0.1 Score on a scale
Standard Deviation 8.27
|
SECONDARY outcome
Timeframe: From first dose up to 30 days after the last dose of study drug; up to approximately 4 years and 3 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=249 Participants
Tislelizumab 200 mg administered intravenously once every 3 weeks until unacceptable toxicity, withdrawal of consent, or the time point at which the participant was no longer benefiting from therapy, as assessed by the investigator, whichever occurred first
|
|---|---|
|
Number of Participants With Adverse Events
Participants with a serious TEAE
|
94 Participants
|
|
Number of Participants With Adverse Events
Participants with at least 1 TEAE
|
236 Participants
|
Adverse Events
Tislelizumab
Serious events: 94 serious events
Other events: 226 other events
Deaths: 180 deaths
Serious adverse events
| Measure |
Tislelizumab
n=249 participants at risk
Tislelizumab 200 mg administered intravenously once every 3 weeks until unacceptable toxicity, withdrawal of consent, or the time point at which the participant was no longer benefiting from therapy, as assessed by the investigator, whichever occurred first
|
|---|---|
|
Cardiac disorders
Cardiac failure congestive
|
0.40%
1/249 • From first dose to 30 days after last dose of study drug (up to approximately 4 years and 3 months)
Defined as an adverse event that had an onset date or worsening in severity from baseline (pretreatment) on or after the date of first dose of study drug up to 30 days after study drug discontinuation or initiation of new anticancer therapy.
|
|
Cardiac disorders
Myocarditis
|
0.80%
2/249 • From first dose to 30 days after last dose of study drug (up to approximately 4 years and 3 months)
Defined as an adverse event that had an onset date or worsening in severity from baseline (pretreatment) on or after the date of first dose of study drug up to 30 days after study drug discontinuation or initiation of new anticancer therapy.
|
|
Cardiac disorders
Palpitations
|
0.40%
1/249 • From first dose to 30 days after last dose of study drug (up to approximately 4 years and 3 months)
Defined as an adverse event that had an onset date or worsening in severity from baseline (pretreatment) on or after the date of first dose of study drug up to 30 days after study drug discontinuation or initiation of new anticancer therapy.
|
|
Endocrine disorders
Primary adrenal insufficiency
|
0.40%
1/249 • From first dose to 30 days after last dose of study drug (up to approximately 4 years and 3 months)
Defined as an adverse event that had an onset date or worsening in severity from baseline (pretreatment) on or after the date of first dose of study drug up to 30 days after study drug discontinuation or initiation of new anticancer therapy.
|
|
Eye disorders
Eyelid ptosis
|
0.40%
1/249 • From first dose to 30 days after last dose of study drug (up to approximately 4 years and 3 months)
Defined as an adverse event that had an onset date or worsening in severity from baseline (pretreatment) on or after the date of first dose of study drug up to 30 days after study drug discontinuation or initiation of new anticancer therapy.
|
|
Gastrointestinal disorders
Abdominal pain
|
1.2%
3/249 • From first dose to 30 days after last dose of study drug (up to approximately 4 years and 3 months)
Defined as an adverse event that had an onset date or worsening in severity from baseline (pretreatment) on or after the date of first dose of study drug up to 30 days after study drug discontinuation or initiation of new anticancer therapy.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.80%
2/249 • From first dose to 30 days after last dose of study drug (up to approximately 4 years and 3 months)
Defined as an adverse event that had an onset date or worsening in severity from baseline (pretreatment) on or after the date of first dose of study drug up to 30 days after study drug discontinuation or initiation of new anticancer therapy.
|
|
Gastrointestinal disorders
Ascites
|
3.6%
9/249 • From first dose to 30 days after last dose of study drug (up to approximately 4 years and 3 months)
Defined as an adverse event that had an onset date or worsening in severity from baseline (pretreatment) on or after the date of first dose of study drug up to 30 days after study drug discontinuation or initiation of new anticancer therapy.
|
|
Gastrointestinal disorders
Colitis
|
0.40%
1/249 • From first dose to 30 days after last dose of study drug (up to approximately 4 years and 3 months)
Defined as an adverse event that had an onset date or worsening in severity from baseline (pretreatment) on or after the date of first dose of study drug up to 30 days after study drug discontinuation or initiation of new anticancer therapy.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.40%
1/249 • From first dose to 30 days after last dose of study drug (up to approximately 4 years and 3 months)
Defined as an adverse event that had an onset date or worsening in severity from baseline (pretreatment) on or after the date of first dose of study drug up to 30 days after study drug discontinuation or initiation of new anticancer therapy.
|
|
Gastrointestinal disorders
Duodenal ulcer haemorrhage
|
0.80%
2/249 • From first dose to 30 days after last dose of study drug (up to approximately 4 years and 3 months)
Defined as an adverse event that had an onset date or worsening in severity from baseline (pretreatment) on or after the date of first dose of study drug up to 30 days after study drug discontinuation or initiation of new anticancer therapy.
|
|
Gastrointestinal disorders
Gastric haemorrhage
|
0.40%
1/249 • From first dose to 30 days after last dose of study drug (up to approximately 4 years and 3 months)
Defined as an adverse event that had an onset date or worsening in severity from baseline (pretreatment) on or after the date of first dose of study drug up to 30 days after study drug discontinuation or initiation of new anticancer therapy.
|
|
Gastrointestinal disorders
Haematemesis
|
0.40%
1/249 • From first dose to 30 days after last dose of study drug (up to approximately 4 years and 3 months)
Defined as an adverse event that had an onset date or worsening in severity from baseline (pretreatment) on or after the date of first dose of study drug up to 30 days after study drug discontinuation or initiation of new anticancer therapy.
|
|
Gastrointestinal disorders
Haemoperitoneum
|
0.40%
1/249 • From first dose to 30 days after last dose of study drug (up to approximately 4 years and 3 months)
Defined as an adverse event that had an onset date or worsening in severity from baseline (pretreatment) on or after the date of first dose of study drug up to 30 days after study drug discontinuation or initiation of new anticancer therapy.
|
|
Gastrointestinal disorders
Immune-mediated enterocolitis
|
0.40%
1/249 • From first dose to 30 days after last dose of study drug (up to approximately 4 years and 3 months)
Defined as an adverse event that had an onset date or worsening in severity from baseline (pretreatment) on or after the date of first dose of study drug up to 30 days after study drug discontinuation or initiation of new anticancer therapy.
|
|
Gastrointestinal disorders
Lower gastrointestinal haemorrhage
|
0.40%
1/249 • From first dose to 30 days after last dose of study drug (up to approximately 4 years and 3 months)
Defined as an adverse event that had an onset date or worsening in severity from baseline (pretreatment) on or after the date of first dose of study drug up to 30 days after study drug discontinuation or initiation of new anticancer therapy.
|
|
Gastrointestinal disorders
Nausea
|
0.40%
1/249 • From first dose to 30 days after last dose of study drug (up to approximately 4 years and 3 months)
Defined as an adverse event that had an onset date or worsening in severity from baseline (pretreatment) on or after the date of first dose of study drug up to 30 days after study drug discontinuation or initiation of new anticancer therapy.
|
|
Gastrointestinal disorders
Obstruction gastric
|
0.40%
1/249 • From first dose to 30 days after last dose of study drug (up to approximately 4 years and 3 months)
Defined as an adverse event that had an onset date or worsening in severity from baseline (pretreatment) on or after the date of first dose of study drug up to 30 days after study drug discontinuation or initiation of new anticancer therapy.
|
|
Gastrointestinal disorders
Pancreatitis acute
|
0.40%
1/249 • From first dose to 30 days after last dose of study drug (up to approximately 4 years and 3 months)
Defined as an adverse event that had an onset date or worsening in severity from baseline (pretreatment) on or after the date of first dose of study drug up to 30 days after study drug discontinuation or initiation of new anticancer therapy.
|
|
Gastrointestinal disorders
Upper gastrointestinal haemorrhage
|
1.6%
4/249 • From first dose to 30 days after last dose of study drug (up to approximately 4 years and 3 months)
Defined as an adverse event that had an onset date or worsening in severity from baseline (pretreatment) on or after the date of first dose of study drug up to 30 days after study drug discontinuation or initiation of new anticancer therapy.
|
|
Gastrointestinal disorders
Varices oesophageal
|
0.40%
1/249 • From first dose to 30 days after last dose of study drug (up to approximately 4 years and 3 months)
Defined as an adverse event that had an onset date or worsening in severity from baseline (pretreatment) on or after the date of first dose of study drug up to 30 days after study drug discontinuation or initiation of new anticancer therapy.
|
|
Gastrointestinal disorders
Vomiting
|
0.40%
1/249 • From first dose to 30 days after last dose of study drug (up to approximately 4 years and 3 months)
Defined as an adverse event that had an onset date or worsening in severity from baseline (pretreatment) on or after the date of first dose of study drug up to 30 days after study drug discontinuation or initiation of new anticancer therapy.
|
|
General disorders
Asthenia
|
0.40%
1/249 • From first dose to 30 days after last dose of study drug (up to approximately 4 years and 3 months)
Defined as an adverse event that had an onset date or worsening in severity from baseline (pretreatment) on or after the date of first dose of study drug up to 30 days after study drug discontinuation or initiation of new anticancer therapy.
|
|
General disorders
Chest pain
|
0.80%
2/249 • From first dose to 30 days after last dose of study drug (up to approximately 4 years and 3 months)
Defined as an adverse event that had an onset date or worsening in severity from baseline (pretreatment) on or after the date of first dose of study drug up to 30 days after study drug discontinuation or initiation of new anticancer therapy.
|
|
General disorders
Death
|
0.80%
2/249 • From first dose to 30 days after last dose of study drug (up to approximately 4 years and 3 months)
Defined as an adverse event that had an onset date or worsening in severity from baseline (pretreatment) on or after the date of first dose of study drug up to 30 days after study drug discontinuation or initiation of new anticancer therapy.
|
|
General disorders
General physical health deterioration
|
1.2%
3/249 • From first dose to 30 days after last dose of study drug (up to approximately 4 years and 3 months)
Defined as an adverse event that had an onset date or worsening in severity from baseline (pretreatment) on or after the date of first dose of study drug up to 30 days after study drug discontinuation or initiation of new anticancer therapy.
|
|
General disorders
Multiple organ dysfunction syndrome
|
0.80%
2/249 • From first dose to 30 days after last dose of study drug (up to approximately 4 years and 3 months)
Defined as an adverse event that had an onset date or worsening in severity from baseline (pretreatment) on or after the date of first dose of study drug up to 30 days after study drug discontinuation or initiation of new anticancer therapy.
|
|
General disorders
Pyrexia
|
0.40%
1/249 • From first dose to 30 days after last dose of study drug (up to approximately 4 years and 3 months)
Defined as an adverse event that had an onset date or worsening in severity from baseline (pretreatment) on or after the date of first dose of study drug up to 30 days after study drug discontinuation or initiation of new anticancer therapy.
|
|
Hepatobiliary disorders
Acute hepatic failure
|
0.40%
1/249 • From first dose to 30 days after last dose of study drug (up to approximately 4 years and 3 months)
Defined as an adverse event that had an onset date or worsening in severity from baseline (pretreatment) on or after the date of first dose of study drug up to 30 days after study drug discontinuation or initiation of new anticancer therapy.
|
|
Hepatobiliary disorders
Bile duct stenosis
|
0.40%
1/249 • From first dose to 30 days after last dose of study drug (up to approximately 4 years and 3 months)
Defined as an adverse event that had an onset date or worsening in severity from baseline (pretreatment) on or after the date of first dose of study drug up to 30 days after study drug discontinuation or initiation of new anticancer therapy.
|
|
Hepatobiliary disorders
Budd-Chiari syndrome
|
0.40%
1/249 • From first dose to 30 days after last dose of study drug (up to approximately 4 years and 3 months)
Defined as an adverse event that had an onset date or worsening in severity from baseline (pretreatment) on or after the date of first dose of study drug up to 30 days after study drug discontinuation or initiation of new anticancer therapy.
|
|
Hepatobiliary disorders
Hepatic artery aneurysm
|
0.40%
1/249 • From first dose to 30 days after last dose of study drug (up to approximately 4 years and 3 months)
Defined as an adverse event that had an onset date or worsening in severity from baseline (pretreatment) on or after the date of first dose of study drug up to 30 days after study drug discontinuation or initiation of new anticancer therapy.
|
|
Hepatobiliary disorders
Hepatic failure
|
2.8%
7/249 • From first dose to 30 days after last dose of study drug (up to approximately 4 years and 3 months)
Defined as an adverse event that had an onset date or worsening in severity from baseline (pretreatment) on or after the date of first dose of study drug up to 30 days after study drug discontinuation or initiation of new anticancer therapy.
|
|
Hepatobiliary disorders
Hepatic function abnormal
|
1.6%
4/249 • From first dose to 30 days after last dose of study drug (up to approximately 4 years and 3 months)
Defined as an adverse event that had an onset date or worsening in severity from baseline (pretreatment) on or after the date of first dose of study drug up to 30 days after study drug discontinuation or initiation of new anticancer therapy.
|
|
Hepatobiliary disorders
Hepatitis
|
0.40%
1/249 • From first dose to 30 days after last dose of study drug (up to approximately 4 years and 3 months)
Defined as an adverse event that had an onset date or worsening in severity from baseline (pretreatment) on or after the date of first dose of study drug up to 30 days after study drug discontinuation or initiation of new anticancer therapy.
|
|
Hepatobiliary disorders
Hepatomegaly
|
0.40%
1/249 • From first dose to 30 days after last dose of study drug (up to approximately 4 years and 3 months)
Defined as an adverse event that had an onset date or worsening in severity from baseline (pretreatment) on or after the date of first dose of study drug up to 30 days after study drug discontinuation or initiation of new anticancer therapy.
|
|
Hepatobiliary disorders
Hepatorenal syndrome
|
0.40%
1/249 • From first dose to 30 days after last dose of study drug (up to approximately 4 years and 3 months)
Defined as an adverse event that had an onset date or worsening in severity from baseline (pretreatment) on or after the date of first dose of study drug up to 30 days after study drug discontinuation or initiation of new anticancer therapy.
|
|
Hepatobiliary disorders
Hyperbilirubinaemia
|
0.40%
1/249 • From first dose to 30 days after last dose of study drug (up to approximately 4 years and 3 months)
Defined as an adverse event that had an onset date or worsening in severity from baseline (pretreatment) on or after the date of first dose of study drug up to 30 days after study drug discontinuation or initiation of new anticancer therapy.
|
|
Hepatobiliary disorders
Immune-mediated hepatitis
|
0.80%
2/249 • From first dose to 30 days after last dose of study drug (up to approximately 4 years and 3 months)
Defined as an adverse event that had an onset date or worsening in severity from baseline (pretreatment) on or after the date of first dose of study drug up to 30 days after study drug discontinuation or initiation of new anticancer therapy.
|
|
Hepatobiliary disorders
Jaundice cholestatic
|
0.80%
2/249 • From first dose to 30 days after last dose of study drug (up to approximately 4 years and 3 months)
Defined as an adverse event that had an onset date or worsening in severity from baseline (pretreatment) on or after the date of first dose of study drug up to 30 days after study drug discontinuation or initiation of new anticancer therapy.
|
|
Infections and infestations
COVID-19
|
0.40%
1/249 • From first dose to 30 days after last dose of study drug (up to approximately 4 years and 3 months)
Defined as an adverse event that had an onset date or worsening in severity from baseline (pretreatment) on or after the date of first dose of study drug up to 30 days after study drug discontinuation or initiation of new anticancer therapy.
|
|
Infections and infestations
Gastroenteritis
|
0.80%
2/249 • From first dose to 30 days after last dose of study drug (up to approximately 4 years and 3 months)
Defined as an adverse event that had an onset date or worsening in severity from baseline (pretreatment) on or after the date of first dose of study drug up to 30 days after study drug discontinuation or initiation of new anticancer therapy.
|
|
Infections and infestations
Influenza
|
0.40%
1/249 • From first dose to 30 days after last dose of study drug (up to approximately 4 years and 3 months)
Defined as an adverse event that had an onset date or worsening in severity from baseline (pretreatment) on or after the date of first dose of study drug up to 30 days after study drug discontinuation or initiation of new anticancer therapy.
|
|
Infections and infestations
Peritonitis
|
0.40%
1/249 • From first dose to 30 days after last dose of study drug (up to approximately 4 years and 3 months)
Defined as an adverse event that had an onset date or worsening in severity from baseline (pretreatment) on or after the date of first dose of study drug up to 30 days after study drug discontinuation or initiation of new anticancer therapy.
|
|
Infections and infestations
Pharyngitis
|
0.40%
1/249 • From first dose to 30 days after last dose of study drug (up to approximately 4 years and 3 months)
Defined as an adverse event that had an onset date or worsening in severity from baseline (pretreatment) on or after the date of first dose of study drug up to 30 days after study drug discontinuation or initiation of new anticancer therapy.
|
|
Infections and infestations
Pneumonia
|
2.0%
5/249 • From first dose to 30 days after last dose of study drug (up to approximately 4 years and 3 months)
Defined as an adverse event that had an onset date or worsening in severity from baseline (pretreatment) on or after the date of first dose of study drug up to 30 days after study drug discontinuation or initiation of new anticancer therapy.
|
|
Infections and infestations
Sepsis
|
1.2%
3/249 • From first dose to 30 days after last dose of study drug (up to approximately 4 years and 3 months)
Defined as an adverse event that had an onset date or worsening in severity from baseline (pretreatment) on or after the date of first dose of study drug up to 30 days after study drug discontinuation or initiation of new anticancer therapy.
|
|
Infections and infestations
Septic shock
|
0.40%
1/249 • From first dose to 30 days after last dose of study drug (up to approximately 4 years and 3 months)
Defined as an adverse event that had an onset date or worsening in severity from baseline (pretreatment) on or after the date of first dose of study drug up to 30 days after study drug discontinuation or initiation of new anticancer therapy.
|
|
Infections and infestations
Staphylococcal bacteraemia
|
0.80%
2/249 • From first dose to 30 days after last dose of study drug (up to approximately 4 years and 3 months)
Defined as an adverse event that had an onset date or worsening in severity from baseline (pretreatment) on or after the date of first dose of study drug up to 30 days after study drug discontinuation or initiation of new anticancer therapy.
|
|
Injury, poisoning and procedural complications
Fall
|
0.40%
1/249 • From first dose to 30 days after last dose of study drug (up to approximately 4 years and 3 months)
Defined as an adverse event that had an onset date or worsening in severity from baseline (pretreatment) on or after the date of first dose of study drug up to 30 days after study drug discontinuation or initiation of new anticancer therapy.
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
0.40%
1/249 • From first dose to 30 days after last dose of study drug (up to approximately 4 years and 3 months)
Defined as an adverse event that had an onset date or worsening in severity from baseline (pretreatment) on or after the date of first dose of study drug up to 30 days after study drug discontinuation or initiation of new anticancer therapy.
|
|
Investigations
Alanine aminotransferase increased
|
0.80%
2/249 • From first dose to 30 days after last dose of study drug (up to approximately 4 years and 3 months)
Defined as an adverse event that had an onset date or worsening in severity from baseline (pretreatment) on or after the date of first dose of study drug up to 30 days after study drug discontinuation or initiation of new anticancer therapy.
|
|
Investigations
Aspartate aminotransferase increased
|
2.0%
5/249 • From first dose to 30 days after last dose of study drug (up to approximately 4 years and 3 months)
Defined as an adverse event that had an onset date or worsening in severity from baseline (pretreatment) on or after the date of first dose of study drug up to 30 days after study drug discontinuation or initiation of new anticancer therapy.
|
|
Investigations
Blood bilirubin increased
|
1.2%
3/249 • From first dose to 30 days after last dose of study drug (up to approximately 4 years and 3 months)
Defined as an adverse event that had an onset date or worsening in severity from baseline (pretreatment) on or after the date of first dose of study drug up to 30 days after study drug discontinuation or initiation of new anticancer therapy.
|
|
Investigations
Transaminases increased
|
0.40%
1/249 • From first dose to 30 days after last dose of study drug (up to approximately 4 years and 3 months)
Defined as an adverse event that had an onset date or worsening in severity from baseline (pretreatment) on or after the date of first dose of study drug up to 30 days after study drug discontinuation or initiation of new anticancer therapy.
|
|
Metabolism and nutrition disorders
Cachexia
|
0.40%
1/249 • From first dose to 30 days after last dose of study drug (up to approximately 4 years and 3 months)
Defined as an adverse event that had an onset date or worsening in severity from baseline (pretreatment) on or after the date of first dose of study drug up to 30 days after study drug discontinuation or initiation of new anticancer therapy.
|
|
Metabolism and nutrition disorders
Diabetic metabolic decompensation
|
0.40%
1/249 • From first dose to 30 days after last dose of study drug (up to approximately 4 years and 3 months)
Defined as an adverse event that had an onset date or worsening in severity from baseline (pretreatment) on or after the date of first dose of study drug up to 30 days after study drug discontinuation or initiation of new anticancer therapy.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.80%
2/249 • From first dose to 30 days after last dose of study drug (up to approximately 4 years and 3 months)
Defined as an adverse event that had an onset date or worsening in severity from baseline (pretreatment) on or after the date of first dose of study drug up to 30 days after study drug discontinuation or initiation of new anticancer therapy.
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.40%
1/249 • From first dose to 30 days after last dose of study drug (up to approximately 4 years and 3 months)
Defined as an adverse event that had an onset date or worsening in severity from baseline (pretreatment) on or after the date of first dose of study drug up to 30 days after study drug discontinuation or initiation of new anticancer therapy.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.80%
2/249 • From first dose to 30 days after last dose of study drug (up to approximately 4 years and 3 months)
Defined as an adverse event that had an onset date or worsening in severity from baseline (pretreatment) on or after the date of first dose of study drug up to 30 days after study drug discontinuation or initiation of new anticancer therapy.
|
|
Musculoskeletal and connective tissue disorders
Myositis
|
0.80%
2/249 • From first dose to 30 days after last dose of study drug (up to approximately 4 years and 3 months)
Defined as an adverse event that had an onset date or worsening in severity from baseline (pretreatment) on or after the date of first dose of study drug up to 30 days after study drug discontinuation or initiation of new anticancer therapy.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adenocarcinoma gastric
|
0.40%
1/249 • From first dose to 30 days after last dose of study drug (up to approximately 4 years and 3 months)
Defined as an adverse event that had an onset date or worsening in severity from baseline (pretreatment) on or after the date of first dose of study drug up to 30 days after study drug discontinuation or initiation of new anticancer therapy.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Intracranial tumour haemorrhage
|
0.40%
1/249 • From first dose to 30 days after last dose of study drug (up to approximately 4 years and 3 months)
Defined as an adverse event that had an onset date or worsening in severity from baseline (pretreatment) on or after the date of first dose of study drug up to 30 days after study drug discontinuation or initiation of new anticancer therapy.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasm swelling
|
0.40%
1/249 • From first dose to 30 days after last dose of study drug (up to approximately 4 years and 3 months)
Defined as an adverse event that had an onset date or worsening in severity from baseline (pretreatment) on or after the date of first dose of study drug up to 30 days after study drug discontinuation or initiation of new anticancer therapy.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Non-small cell lung cancer
|
0.40%
1/249 • From first dose to 30 days after last dose of study drug (up to approximately 4 years and 3 months)
Defined as an adverse event that had an onset date or worsening in severity from baseline (pretreatment) on or after the date of first dose of study drug up to 30 days after study drug discontinuation or initiation of new anticancer therapy.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Rectal adenocarcinoma
|
0.40%
1/249 • From first dose to 30 days after last dose of study drug (up to approximately 4 years and 3 months)
Defined as an adverse event that had an onset date or worsening in severity from baseline (pretreatment) on or after the date of first dose of study drug up to 30 days after study drug discontinuation or initiation of new anticancer therapy.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour haemorrhage
|
0.40%
1/249 • From first dose to 30 days after last dose of study drug (up to approximately 4 years and 3 months)
Defined as an adverse event that had an onset date or worsening in severity from baseline (pretreatment) on or after the date of first dose of study drug up to 30 days after study drug discontinuation or initiation of new anticancer therapy.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour pain
|
0.40%
1/249 • From first dose to 30 days after last dose of study drug (up to approximately 4 years and 3 months)
Defined as an adverse event that had an onset date or worsening in severity from baseline (pretreatment) on or after the date of first dose of study drug up to 30 days after study drug discontinuation or initiation of new anticancer therapy.
|
|
Nervous system disorders
Brain oedema
|
0.40%
1/249 • From first dose to 30 days after last dose of study drug (up to approximately 4 years and 3 months)
Defined as an adverse event that had an onset date or worsening in severity from baseline (pretreatment) on or after the date of first dose of study drug up to 30 days after study drug discontinuation or initiation of new anticancer therapy.
|
|
Nervous system disorders
Haemorrhage intracranial
|
0.80%
2/249 • From first dose to 30 days after last dose of study drug (up to approximately 4 years and 3 months)
Defined as an adverse event that had an onset date or worsening in severity from baseline (pretreatment) on or after the date of first dose of study drug up to 30 days after study drug discontinuation or initiation of new anticancer therapy.
|
|
Nervous system disorders
Hepatic encephalopathy
|
0.80%
2/249 • From first dose to 30 days after last dose of study drug (up to approximately 4 years and 3 months)
Defined as an adverse event that had an onset date or worsening in severity from baseline (pretreatment) on or after the date of first dose of study drug up to 30 days after study drug discontinuation or initiation of new anticancer therapy.
|
|
Nervous system disorders
Loss of consciousness
|
0.40%
1/249 • From first dose to 30 days after last dose of study drug (up to approximately 4 years and 3 months)
Defined as an adverse event that had an onset date or worsening in severity from baseline (pretreatment) on or after the date of first dose of study drug up to 30 days after study drug discontinuation or initiation of new anticancer therapy.
|
|
Nervous system disorders
Neuropathy peripheral
|
0.40%
1/249 • From first dose to 30 days after last dose of study drug (up to approximately 4 years and 3 months)
Defined as an adverse event that had an onset date or worsening in severity from baseline (pretreatment) on or after the date of first dose of study drug up to 30 days after study drug discontinuation or initiation of new anticancer therapy.
|
|
Nervous system disorders
Seizure
|
0.40%
1/249 • From first dose to 30 days after last dose of study drug (up to approximately 4 years and 3 months)
Defined as an adverse event that had an onset date or worsening in severity from baseline (pretreatment) on or after the date of first dose of study drug up to 30 days after study drug discontinuation or initiation of new anticancer therapy.
|
|
Nervous system disorders
VIth nerve paralysis
|
0.40%
1/249 • From first dose to 30 days after last dose of study drug (up to approximately 4 years and 3 months)
Defined as an adverse event that had an onset date or worsening in severity from baseline (pretreatment) on or after the date of first dose of study drug up to 30 days after study drug discontinuation or initiation of new anticancer therapy.
|
|
Renal and urinary disorders
Acute kidney injury
|
0.40%
1/249 • From first dose to 30 days after last dose of study drug (up to approximately 4 years and 3 months)
Defined as an adverse event that had an onset date or worsening in severity from baseline (pretreatment) on or after the date of first dose of study drug up to 30 days after study drug discontinuation or initiation of new anticancer therapy.
|
|
Renal and urinary disorders
Renal failure
|
0.80%
2/249 • From first dose to 30 days after last dose of study drug (up to approximately 4 years and 3 months)
Defined as an adverse event that had an onset date or worsening in severity from baseline (pretreatment) on or after the date of first dose of study drug up to 30 days after study drug discontinuation or initiation of new anticancer therapy.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.40%
1/249 • From first dose to 30 days after last dose of study drug (up to approximately 4 years and 3 months)
Defined as an adverse event that had an onset date or worsening in severity from baseline (pretreatment) on or after the date of first dose of study drug up to 30 days after study drug discontinuation or initiation of new anticancer therapy.
|
|
Respiratory, thoracic and mediastinal disorders
Haemothorax
|
0.40%
1/249 • From first dose to 30 days after last dose of study drug (up to approximately 4 years and 3 months)
Defined as an adverse event that had an onset date or worsening in severity from baseline (pretreatment) on or after the date of first dose of study drug up to 30 days after study drug discontinuation or initiation of new anticancer therapy.
|
|
Respiratory, thoracic and mediastinal disorders
Immune-mediated lung disease
|
0.40%
1/249 • From first dose to 30 days after last dose of study drug (up to approximately 4 years and 3 months)
Defined as an adverse event that had an onset date or worsening in severity from baseline (pretreatment) on or after the date of first dose of study drug up to 30 days after study drug discontinuation or initiation of new anticancer therapy.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.80%
2/249 • From first dose to 30 days after last dose of study drug (up to approximately 4 years and 3 months)
Defined as an adverse event that had an onset date or worsening in severity from baseline (pretreatment) on or after the date of first dose of study drug up to 30 days after study drug discontinuation or initiation of new anticancer therapy.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.80%
2/249 • From first dose to 30 days after last dose of study drug (up to approximately 4 years and 3 months)
Defined as an adverse event that had an onset date or worsening in severity from baseline (pretreatment) on or after the date of first dose of study drug up to 30 days after study drug discontinuation or initiation of new anticancer therapy.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary haemorrhage
|
0.40%
1/249 • From first dose to 30 days after last dose of study drug (up to approximately 4 years and 3 months)
Defined as an adverse event that had an onset date or worsening in severity from baseline (pretreatment) on or after the date of first dose of study drug up to 30 days after study drug discontinuation or initiation of new anticancer therapy.
|
|
Skin and subcutaneous tissue disorders
Diabetic foot
|
0.40%
1/249 • From first dose to 30 days after last dose of study drug (up to approximately 4 years and 3 months)
Defined as an adverse event that had an onset date or worsening in severity from baseline (pretreatment) on or after the date of first dose of study drug up to 30 days after study drug discontinuation or initiation of new anticancer therapy.
|
|
Skin and subcutaneous tissue disorders
Hidradenitis
|
0.40%
1/249 • From first dose to 30 days after last dose of study drug (up to approximately 4 years and 3 months)
Defined as an adverse event that had an onset date or worsening in severity from baseline (pretreatment) on or after the date of first dose of study drug up to 30 days after study drug discontinuation or initiation of new anticancer therapy.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.40%
1/249 • From first dose to 30 days after last dose of study drug (up to approximately 4 years and 3 months)
Defined as an adverse event that had an onset date or worsening in severity from baseline (pretreatment) on or after the date of first dose of study drug up to 30 days after study drug discontinuation or initiation of new anticancer therapy.
|
|
Vascular disorders
Superior vena cava occlusion
|
0.40%
1/249 • From first dose to 30 days after last dose of study drug (up to approximately 4 years and 3 months)
Defined as an adverse event that had an onset date or worsening in severity from baseline (pretreatment) on or after the date of first dose of study drug up to 30 days after study drug discontinuation or initiation of new anticancer therapy.
|
Other adverse events
| Measure |
Tislelizumab
n=249 participants at risk
Tislelizumab 200 mg administered intravenously once every 3 weeks until unacceptable toxicity, withdrawal of consent, or the time point at which the participant was no longer benefiting from therapy, as assessed by the investigator, whichever occurred first
|
|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
12.9%
32/249 • From first dose to 30 days after last dose of study drug (up to approximately 4 years and 3 months)
Defined as an adverse event that had an onset date or worsening in severity from baseline (pretreatment) on or after the date of first dose of study drug up to 30 days after study drug discontinuation or initiation of new anticancer therapy.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
6.0%
15/249 • From first dose to 30 days after last dose of study drug (up to approximately 4 years and 3 months)
Defined as an adverse event that had an onset date or worsening in severity from baseline (pretreatment) on or after the date of first dose of study drug up to 30 days after study drug discontinuation or initiation of new anticancer therapy.
|
|
Endocrine disorders
Hypothyroidism
|
9.2%
23/249 • From first dose to 30 days after last dose of study drug (up to approximately 4 years and 3 months)
Defined as an adverse event that had an onset date or worsening in severity from baseline (pretreatment) on or after the date of first dose of study drug up to 30 days after study drug discontinuation or initiation of new anticancer therapy.
|
|
Gastrointestinal disorders
Abdominal distension
|
8.4%
21/249 • From first dose to 30 days after last dose of study drug (up to approximately 4 years and 3 months)
Defined as an adverse event that had an onset date or worsening in severity from baseline (pretreatment) on or after the date of first dose of study drug up to 30 days after study drug discontinuation or initiation of new anticancer therapy.
|
|
Gastrointestinal disorders
Abdominal pain
|
10.4%
26/249 • From first dose to 30 days after last dose of study drug (up to approximately 4 years and 3 months)
Defined as an adverse event that had an onset date or worsening in severity from baseline (pretreatment) on or after the date of first dose of study drug up to 30 days after study drug discontinuation or initiation of new anticancer therapy.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
6.8%
17/249 • From first dose to 30 days after last dose of study drug (up to approximately 4 years and 3 months)
Defined as an adverse event that had an onset date or worsening in severity from baseline (pretreatment) on or after the date of first dose of study drug up to 30 days after study drug discontinuation or initiation of new anticancer therapy.
|
|
Gastrointestinal disorders
Ascites
|
7.6%
19/249 • From first dose to 30 days after last dose of study drug (up to approximately 4 years and 3 months)
Defined as an adverse event that had an onset date or worsening in severity from baseline (pretreatment) on or after the date of first dose of study drug up to 30 days after study drug discontinuation or initiation of new anticancer therapy.
|
|
Gastrointestinal disorders
Constipation
|
9.6%
24/249 • From first dose to 30 days after last dose of study drug (up to approximately 4 years and 3 months)
Defined as an adverse event that had an onset date or worsening in severity from baseline (pretreatment) on or after the date of first dose of study drug up to 30 days after study drug discontinuation or initiation of new anticancer therapy.
|
|
Gastrointestinal disorders
Diarrhoea
|
12.0%
30/249 • From first dose to 30 days after last dose of study drug (up to approximately 4 years and 3 months)
Defined as an adverse event that had an onset date or worsening in severity from baseline (pretreatment) on or after the date of first dose of study drug up to 30 days after study drug discontinuation or initiation of new anticancer therapy.
|
|
Gastrointestinal disorders
Nausea
|
6.0%
15/249 • From first dose to 30 days after last dose of study drug (up to approximately 4 years and 3 months)
Defined as an adverse event that had an onset date or worsening in severity from baseline (pretreatment) on or after the date of first dose of study drug up to 30 days after study drug discontinuation or initiation of new anticancer therapy.
|
|
Gastrointestinal disorders
Stomatitis
|
3.2%
8/249 • From first dose to 30 days after last dose of study drug (up to approximately 4 years and 3 months)
Defined as an adverse event that had an onset date or worsening in severity from baseline (pretreatment) on or after the date of first dose of study drug up to 30 days after study drug discontinuation or initiation of new anticancer therapy.
|
|
Gastrointestinal disorders
Vomiting
|
8.4%
21/249 • From first dose to 30 days after last dose of study drug (up to approximately 4 years and 3 months)
Defined as an adverse event that had an onset date or worsening in severity from baseline (pretreatment) on or after the date of first dose of study drug up to 30 days after study drug discontinuation or initiation of new anticancer therapy.
|
|
General disorders
Asthenia
|
16.1%
40/249 • From first dose to 30 days after last dose of study drug (up to approximately 4 years and 3 months)
Defined as an adverse event that had an onset date or worsening in severity from baseline (pretreatment) on or after the date of first dose of study drug up to 30 days after study drug discontinuation or initiation of new anticancer therapy.
|
|
General disorders
Fatigue
|
11.2%
28/249 • From first dose to 30 days after last dose of study drug (up to approximately 4 years and 3 months)
Defined as an adverse event that had an onset date or worsening in severity from baseline (pretreatment) on or after the date of first dose of study drug up to 30 days after study drug discontinuation or initiation of new anticancer therapy.
|
|
General disorders
Influenza like illness
|
4.4%
11/249 • From first dose to 30 days after last dose of study drug (up to approximately 4 years and 3 months)
Defined as an adverse event that had an onset date or worsening in severity from baseline (pretreatment) on or after the date of first dose of study drug up to 30 days after study drug discontinuation or initiation of new anticancer therapy.
|
|
General disorders
Oedema peripheral
|
8.4%
21/249 • From first dose to 30 days after last dose of study drug (up to approximately 4 years and 3 months)
Defined as an adverse event that had an onset date or worsening in severity from baseline (pretreatment) on or after the date of first dose of study drug up to 30 days after study drug discontinuation or initiation of new anticancer therapy.
|
|
General disorders
Pyrexia
|
12.9%
32/249 • From first dose to 30 days after last dose of study drug (up to approximately 4 years and 3 months)
Defined as an adverse event that had an onset date or worsening in severity from baseline (pretreatment) on or after the date of first dose of study drug up to 30 days after study drug discontinuation or initiation of new anticancer therapy.
|
|
Infections and infestations
Nasopharyngitis
|
3.2%
8/249 • From first dose to 30 days after last dose of study drug (up to approximately 4 years and 3 months)
Defined as an adverse event that had an onset date or worsening in severity from baseline (pretreatment) on or after the date of first dose of study drug up to 30 days after study drug discontinuation or initiation of new anticancer therapy.
|
|
Infections and infestations
Pneumonia
|
3.6%
9/249 • From first dose to 30 days after last dose of study drug (up to approximately 4 years and 3 months)
Defined as an adverse event that had an onset date or worsening in severity from baseline (pretreatment) on or after the date of first dose of study drug up to 30 days after study drug discontinuation or initiation of new anticancer therapy.
|
|
Infections and infestations
Upper respiratory tract infection
|
4.4%
11/249 • From first dose to 30 days after last dose of study drug (up to approximately 4 years and 3 months)
Defined as an adverse event that had an onset date or worsening in severity from baseline (pretreatment) on or after the date of first dose of study drug up to 30 days after study drug discontinuation or initiation of new anticancer therapy.
|
|
Investigations
Alanine aminotransferase increased
|
20.9%
52/249 • From first dose to 30 days after last dose of study drug (up to approximately 4 years and 3 months)
Defined as an adverse event that had an onset date or worsening in severity from baseline (pretreatment) on or after the date of first dose of study drug up to 30 days after study drug discontinuation or initiation of new anticancer therapy.
|
|
Investigations
Aspartate aminotransferase increased
|
26.5%
66/249 • From first dose to 30 days after last dose of study drug (up to approximately 4 years and 3 months)
Defined as an adverse event that had an onset date or worsening in severity from baseline (pretreatment) on or after the date of first dose of study drug up to 30 days after study drug discontinuation or initiation of new anticancer therapy.
|
|
Investigations
Blood alkaline phosphatase increased
|
8.4%
21/249 • From first dose to 30 days after last dose of study drug (up to approximately 4 years and 3 months)
Defined as an adverse event that had an onset date or worsening in severity from baseline (pretreatment) on or after the date of first dose of study drug up to 30 days after study drug discontinuation or initiation of new anticancer therapy.
|
|
Investigations
Blood bilirubin increased
|
19.3%
48/249 • From first dose to 30 days after last dose of study drug (up to approximately 4 years and 3 months)
Defined as an adverse event that had an onset date or worsening in severity from baseline (pretreatment) on or after the date of first dose of study drug up to 30 days after study drug discontinuation or initiation of new anticancer therapy.
|
|
Investigations
Blood creatine phosphokinase MB increased
|
5.6%
14/249 • From first dose to 30 days after last dose of study drug (up to approximately 4 years and 3 months)
Defined as an adverse event that had an onset date or worsening in severity from baseline (pretreatment) on or after the date of first dose of study drug up to 30 days after study drug discontinuation or initiation of new anticancer therapy.
|
|
Investigations
Blood creatine phosphokinase increased
|
4.0%
10/249 • From first dose to 30 days after last dose of study drug (up to approximately 4 years and 3 months)
Defined as an adverse event that had an onset date or worsening in severity from baseline (pretreatment) on or after the date of first dose of study drug up to 30 days after study drug discontinuation or initiation of new anticancer therapy.
|
|
Investigations
Blood creatinine increased
|
3.2%
8/249 • From first dose to 30 days after last dose of study drug (up to approximately 4 years and 3 months)
Defined as an adverse event that had an onset date or worsening in severity from baseline (pretreatment) on or after the date of first dose of study drug up to 30 days after study drug discontinuation or initiation of new anticancer therapy.
|
|
Investigations
Blood lactate dehydrogenase increased
|
4.4%
11/249 • From first dose to 30 days after last dose of study drug (up to approximately 4 years and 3 months)
Defined as an adverse event that had an onset date or worsening in severity from baseline (pretreatment) on or after the date of first dose of study drug up to 30 days after study drug discontinuation or initiation of new anticancer therapy.
|
|
Investigations
Gamma-glutamyltransferase increased
|
8.0%
20/249 • From first dose to 30 days after last dose of study drug (up to approximately 4 years and 3 months)
Defined as an adverse event that had an onset date or worsening in severity from baseline (pretreatment) on or after the date of first dose of study drug up to 30 days after study drug discontinuation or initiation of new anticancer therapy.
|
|
Investigations
Neutrophil count decreased
|
3.2%
8/249 • From first dose to 30 days after last dose of study drug (up to approximately 4 years and 3 months)
Defined as an adverse event that had an onset date or worsening in severity from baseline (pretreatment) on or after the date of first dose of study drug up to 30 days after study drug discontinuation or initiation of new anticancer therapy.
|
|
Investigations
Platelet count decreased
|
8.4%
21/249 • From first dose to 30 days after last dose of study drug (up to approximately 4 years and 3 months)
Defined as an adverse event that had an onset date or worsening in severity from baseline (pretreatment) on or after the date of first dose of study drug up to 30 days after study drug discontinuation or initiation of new anticancer therapy.
|
|
Investigations
Total bile acids increased
|
3.2%
8/249 • From first dose to 30 days after last dose of study drug (up to approximately 4 years and 3 months)
Defined as an adverse event that had an onset date or worsening in severity from baseline (pretreatment) on or after the date of first dose of study drug up to 30 days after study drug discontinuation or initiation of new anticancer therapy.
|
|
Investigations
Weight decreased
|
6.0%
15/249 • From first dose to 30 days after last dose of study drug (up to approximately 4 years and 3 months)
Defined as an adverse event that had an onset date or worsening in severity from baseline (pretreatment) on or after the date of first dose of study drug up to 30 days after study drug discontinuation or initiation of new anticancer therapy.
|
|
Investigations
White blood cell count decreased
|
6.8%
17/249 • From first dose to 30 days after last dose of study drug (up to approximately 4 years and 3 months)
Defined as an adverse event that had an onset date or worsening in severity from baseline (pretreatment) on or after the date of first dose of study drug up to 30 days after study drug discontinuation or initiation of new anticancer therapy.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
17.3%
43/249 • From first dose to 30 days after last dose of study drug (up to approximately 4 years and 3 months)
Defined as an adverse event that had an onset date or worsening in severity from baseline (pretreatment) on or after the date of first dose of study drug up to 30 days after study drug discontinuation or initiation of new anticancer therapy.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
6.0%
15/249 • From first dose to 30 days after last dose of study drug (up to approximately 4 years and 3 months)
Defined as an adverse event that had an onset date or worsening in severity from baseline (pretreatment) on or after the date of first dose of study drug up to 30 days after study drug discontinuation or initiation of new anticancer therapy.
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
7.2%
18/249 • From first dose to 30 days after last dose of study drug (up to approximately 4 years and 3 months)
Defined as an adverse event that had an onset date or worsening in severity from baseline (pretreatment) on or after the date of first dose of study drug up to 30 days after study drug discontinuation or initiation of new anticancer therapy.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
4.8%
12/249 • From first dose to 30 days after last dose of study drug (up to approximately 4 years and 3 months)
Defined as an adverse event that had an onset date or worsening in severity from baseline (pretreatment) on or after the date of first dose of study drug up to 30 days after study drug discontinuation or initiation of new anticancer therapy.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
3.2%
8/249 • From first dose to 30 days after last dose of study drug (up to approximately 4 years and 3 months)
Defined as an adverse event that had an onset date or worsening in severity from baseline (pretreatment) on or after the date of first dose of study drug up to 30 days after study drug discontinuation or initiation of new anticancer therapy.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
10.0%
25/249 • From first dose to 30 days after last dose of study drug (up to approximately 4 years and 3 months)
Defined as an adverse event that had an onset date or worsening in severity from baseline (pretreatment) on or after the date of first dose of study drug up to 30 days after study drug discontinuation or initiation of new anticancer therapy.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
4.4%
11/249 • From first dose to 30 days after last dose of study drug (up to approximately 4 years and 3 months)
Defined as an adverse event that had an onset date or worsening in severity from baseline (pretreatment) on or after the date of first dose of study drug up to 30 days after study drug discontinuation or initiation of new anticancer therapy.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
4.8%
12/249 • From first dose to 30 days after last dose of study drug (up to approximately 4 years and 3 months)
Defined as an adverse event that had an onset date or worsening in severity from baseline (pretreatment) on or after the date of first dose of study drug up to 30 days after study drug discontinuation or initiation of new anticancer therapy.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
4.4%
11/249 • From first dose to 30 days after last dose of study drug (up to approximately 4 years and 3 months)
Defined as an adverse event that had an onset date or worsening in severity from baseline (pretreatment) on or after the date of first dose of study drug up to 30 days after study drug discontinuation or initiation of new anticancer therapy.
|
|
Nervous system disorders
Dizziness
|
4.4%
11/249 • From first dose to 30 days after last dose of study drug (up to approximately 4 years and 3 months)
Defined as an adverse event that had an onset date or worsening in severity from baseline (pretreatment) on or after the date of first dose of study drug up to 30 days after study drug discontinuation or initiation of new anticancer therapy.
|
|
Nervous system disorders
Headache
|
3.6%
9/249 • From first dose to 30 days after last dose of study drug (up to approximately 4 years and 3 months)
Defined as an adverse event that had an onset date or worsening in severity from baseline (pretreatment) on or after the date of first dose of study drug up to 30 days after study drug discontinuation or initiation of new anticancer therapy.
|
|
Psychiatric disorders
Insomnia
|
6.8%
17/249 • From first dose to 30 days after last dose of study drug (up to approximately 4 years and 3 months)
Defined as an adverse event that had an onset date or worsening in severity from baseline (pretreatment) on or after the date of first dose of study drug up to 30 days after study drug discontinuation or initiation of new anticancer therapy.
|
|
Renal and urinary disorders
Proteinuria
|
3.2%
8/249 • From first dose to 30 days after last dose of study drug (up to approximately 4 years and 3 months)
Defined as an adverse event that had an onset date or worsening in severity from baseline (pretreatment) on or after the date of first dose of study drug up to 30 days after study drug discontinuation or initiation of new anticancer therapy.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
12.0%
30/249 • From first dose to 30 days after last dose of study drug (up to approximately 4 years and 3 months)
Defined as an adverse event that had an onset date or worsening in severity from baseline (pretreatment) on or after the date of first dose of study drug up to 30 days after study drug discontinuation or initiation of new anticancer therapy.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
4.4%
11/249 • From first dose to 30 days after last dose of study drug (up to approximately 4 years and 3 months)
Defined as an adverse event that had an onset date or worsening in severity from baseline (pretreatment) on or after the date of first dose of study drug up to 30 days after study drug discontinuation or initiation of new anticancer therapy.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
14.1%
35/249 • From first dose to 30 days after last dose of study drug (up to approximately 4 years and 3 months)
Defined as an adverse event that had an onset date or worsening in severity from baseline (pretreatment) on or after the date of first dose of study drug up to 30 days after study drug discontinuation or initiation of new anticancer therapy.
|
|
Skin and subcutaneous tissue disorders
Rash
|
9.6%
24/249 • From first dose to 30 days after last dose of study drug (up to approximately 4 years and 3 months)
Defined as an adverse event that had an onset date or worsening in severity from baseline (pretreatment) on or after the date of first dose of study drug up to 30 days after study drug discontinuation or initiation of new anticancer therapy.
|
|
Vascular disorders
Hypertension
|
5.6%
14/249 • From first dose to 30 days after last dose of study drug (up to approximately 4 years and 3 months)
Defined as an adverse event that had an onset date or worsening in severity from baseline (pretreatment) on or after the date of first dose of study drug up to 30 days after study drug discontinuation or initiation of new anticancer therapy.
|
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