Trial Outcomes & Findings for Study of BGB-290 or Placebo in Participants With Advanced or Inoperable Gastric Cancer (NCT NCT03427814)
NCT ID: NCT03427814
Last Updated: 2024-10-26
Results Overview
PFS is defined as the time from randomization to progressive disease (PD) per Response Evaluation Criteria in Solid Tumors ( RECIST) Version 1.1 by investigator assessment or death due to any cause, whichever occurs first.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
136 participants
Primary outcome timeframe
Approximately 23 months
Results posted on
2024-10-26
Participant Flow
Participants were enrolled in multiple study centers in Asia, Australia, Europe, and North America.
Participant milestones
| Measure |
Pamiparib
Participants received 60 milligrams (mg) pamiparib orally twice a day until progressive disease, unacceptable toxicity, death, or withdrawal of consent for study treatment, investigator's discretion, start of new anticancer therapy or Sponsor's decision to end the study
|
Placebo
Participants received 60 mg placebo orally twice daily until progressive disease, unacceptable toxicity, death, withdrawal of consent for study treatment, investigator's discretion, start of new anticancer therapy, or Sponsor's decision to end the study
|
|---|---|---|
|
Overall Study
STARTED
|
71
|
65
|
|
Overall Study
COMPLETED
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
71
|
65
|
Reasons for withdrawal
| Measure |
Pamiparib
Participants received 60 milligrams (mg) pamiparib orally twice a day until progressive disease, unacceptable toxicity, death, or withdrawal of consent for study treatment, investigator's discretion, start of new anticancer therapy or Sponsor's decision to end the study
|
Placebo
Participants received 60 mg placebo orally twice daily until progressive disease, unacceptable toxicity, death, withdrawal of consent for study treatment, investigator's discretion, start of new anticancer therapy, or Sponsor's decision to end the study
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
4
|
4
|
|
Overall Study
Lost to Follow-up
|
0
|
2
|
|
Overall Study
Death
|
42
|
31
|
|
Overall Study
Sponsor's Decision
|
1
|
0
|
|
Overall Study
Investigator's Decision
|
1
|
2
|
|
Overall Study
Disease progression
|
1
|
0
|
|
Overall Study
Treatment Completed
|
0
|
1
|
|
Overall Study
Sponsor's Decision to End study
|
21
|
25
|
|
Overall Study
Transfer to Long Term Extension Study
|
1
|
0
|
Baseline Characteristics
Study of BGB-290 or Placebo in Participants With Advanced or Inoperable Gastric Cancer
Baseline characteristics by cohort
| Measure |
Pamiparib
n=71 Participants
Participants received 60 mg pamiparib orally twice a day until progressive disease, unacceptable toxicity, death, or withdrawal of consent for study treatment, investigator's discretion, start of new anticancer therapy or Sponsor's decision to end the study
|
Placebo
n=65 Participants
Participants received 60 mg placebo orally twice daily until progressive disease, unacceptable toxicity, death, withdrawal of consent for study treatment, investigator's discretion, start of new anticancer therapy, or Sponsor's decision to end the study
|
Total
n=136 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
62.5 years
STANDARD_DEVIATION 9.82 • n=5 Participants
|
62.1 years
STANDARD_DEVIATION 11.23 • n=7 Participants
|
62.3 years
STANDARD_DEVIATION 10.48 • n=5 Participants
|
|
Sex: Female, Male
Female
|
25 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
45 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
46 Participants
n=5 Participants
|
45 Participants
n=7 Participants
|
91 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
4 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
53 Participants
n=5 Participants
|
50 Participants
n=7 Participants
|
103 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
14 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
20 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
35 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black or African America
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
38 Participants
n=5 Participants
|
36 Participants
n=7 Participants
|
74 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other
|
1 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Not Reported/Unknown
|
12 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Approximately 23 monthsPopulation: Intent To Treat (ITT) Analysis Set
PFS is defined as the time from randomization to progressive disease (PD) per Response Evaluation Criteria in Solid Tumors ( RECIST) Version 1.1 by investigator assessment or death due to any cause, whichever occurs first.
Outcome measures
| Measure |
Pamiparib
n=71 Participants
Participants received 60 mg pamiparib orally twice a day until progressive disease, unacceptable toxicity, death, or withdrawal of consent for study treatment, investigator's discretion, start of new anticancer therapy or Sponsor's decision to end the study
|
Placebo
n=65 Participants
Participants received 60 mg placebo orally twice daily until progressive disease, unacceptable toxicity, death, withdrawal of consent for study treatment, investigator's discretion, start of new anticancer therapy, or Sponsor's decision to end the study
|
|---|---|---|
|
Progression Free Survival (PFS) by Investigator Assessment
|
3.7 Months
Interval 1.94 to 5.26
|
2.1 Months
Interval 1.87 to 3.75
|
SECONDARY outcome
Timeframe: Approximately 23 monthsPopulation: ITT Analysis Set
OS is defined as the time from randomization to death due to any cause.
Outcome measures
| Measure |
Pamiparib
n=71 Participants
Participants received 60 mg pamiparib orally twice a day until progressive disease, unacceptable toxicity, death, or withdrawal of consent for study treatment, investigator's discretion, start of new anticancer therapy or Sponsor's decision to end the study
|
Placebo
n=65 Participants
Participants received 60 mg placebo orally twice daily until progressive disease, unacceptable toxicity, death, withdrawal of consent for study treatment, investigator's discretion, start of new anticancer therapy, or Sponsor's decision to end the study
|
|---|---|---|
|
Overall Survival (OS)
|
10.2 Months
Interval 8.71 to 16.33
|
12.0 Months
Interval 8.21 to
NA = Not Estimable due to insufficient number of events
|
SECONDARY outcome
Timeframe: Approximately 23 monthsPopulation: ITT Analysis Set
TSST is defined as the time from randomization until the second subsequent anticancer therapy or death after next-line therapy
Outcome measures
| Measure |
Pamiparib
n=71 Participants
Participants received 60 mg pamiparib orally twice a day until progressive disease, unacceptable toxicity, death, or withdrawal of consent for study treatment, investigator's discretion, start of new anticancer therapy or Sponsor's decision to end the study
|
Placebo
n=65 Participants
Participants received 60 mg placebo orally twice daily until progressive disease, unacceptable toxicity, death, withdrawal of consent for study treatment, investigator's discretion, start of new anticancer therapy, or Sponsor's decision to end the study
|
|---|---|---|
|
Time To Second Subsequent Treatment (TSST)
|
9.8 Months
Interval 8.05 to 10.94
|
9.7 Months
Interval 7.49 to 14.0
|
SECONDARY outcome
Timeframe: Approximately 23 monthsPopulation: Efficacy Evaluable Analysis Set includes all randomized participants who had measurable disease at baseline and had at least one post baseline tumor assessment unless discontinued treatment due to clinical progression or death prior to tumor assessment
ORR is defined as the percentage of participants with a best overall response of Complete Response or Partial Response per RECIST Version 1.1 by investigator assessment
Outcome measures
| Measure |
Pamiparib
n=39 Participants
Participants received 60 mg pamiparib orally twice a day until progressive disease, unacceptable toxicity, death, or withdrawal of consent for study treatment, investigator's discretion, start of new anticancer therapy or Sponsor's decision to end the study
|
Placebo
n=32 Participants
Participants received 60 mg placebo orally twice daily until progressive disease, unacceptable toxicity, death, withdrawal of consent for study treatment, investigator's discretion, start of new anticancer therapy, or Sponsor's decision to end the study
|
|---|---|---|
|
Objective Response Rate (ORR)
|
7.7 Percentage of participants
Interval 1.62 to 20.87
|
6.3 Percentage of participants
Interval 0.77 to 20.81
|
SECONDARY outcome
Timeframe: Approximately 23 monthsPopulation: Efficacy Evaluable Analysis Set; Only responders were included in the analysis.
DOR is defined as the time from the first documented confirmed response of Complete Response or Partial Response to progressive disease (PD) per RECIST Version 1.1 by investigator assessment or death due to any cause, whichever occurs first
Outcome measures
| Measure |
Pamiparib
n=3 Participants
Participants received 60 mg pamiparib orally twice a day until progressive disease, unacceptable toxicity, death, or withdrawal of consent for study treatment, investigator's discretion, start of new anticancer therapy or Sponsor's decision to end the study
|
Placebo
n=2 Participants
Participants received 60 mg placebo orally twice daily until progressive disease, unacceptable toxicity, death, withdrawal of consent for study treatment, investigator's discretion, start of new anticancer therapy, or Sponsor's decision to end the study
|
|---|---|---|
|
Duration of Response (DOR)
|
3.6 Months
Interval 3.48 to
NA = Not estimable due to insufficient number of events
|
NA Months
Interval 5.55 to
NA = Not estimable due to insufficient number of events
|
SECONDARY outcome
Timeframe: Approximately 23 monthsPopulation: Efficacy Evaluable Analysis Set; Only responders were included in the analysis.
Time to response is defined as the time from randomization to the first documented response of Complete Response or Partial Response per RECIST Version 1.1 by investigator assessment
Outcome measures
| Measure |
Pamiparib
n=3 Participants
Participants received 60 mg pamiparib orally twice a day until progressive disease, unacceptable toxicity, death, or withdrawal of consent for study treatment, investigator's discretion, start of new anticancer therapy or Sponsor's decision to end the study
|
Placebo
n=2 Participants
Participants received 60 mg placebo orally twice daily until progressive disease, unacceptable toxicity, death, withdrawal of consent for study treatment, investigator's discretion, start of new anticancer therapy, or Sponsor's decision to end the study
|
|---|---|---|
|
Time To Response
|
3.68 Months
Interval 1.8 to 7.3
|
1.87 Months
Interval 1.87 to 1.9
|
SECONDARY outcome
Timeframe: From start of study treatment until 30 days after the last study drug intake or initiation of new anticancer therapy, whichever occurs first (up to approximately 4 years and 5.5 months)Population: Safety Analysis Set includes all participants in the ITT Analysis Set who receive at least one dose of study treatment (pamiparib or placebo).
Outcome measures
| Measure |
Pamiparib
n=71 Participants
Participants received 60 mg pamiparib orally twice a day until progressive disease, unacceptable toxicity, death, or withdrawal of consent for study treatment, investigator's discretion, start of new anticancer therapy or Sponsor's decision to end the study
|
Placebo
n=65 Participants
Participants received 60 mg placebo orally twice daily until progressive disease, unacceptable toxicity, death, withdrawal of consent for study treatment, investigator's discretion, start of new anticancer therapy, or Sponsor's decision to end the study
|
|---|---|---|
|
Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
Participants With At Least 1 TEAE
|
66 Number of participants
|
61 Number of participants
|
|
Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
Participants with Serious TEAEs
|
17 Number of participants
|
11 Number of participants
|
Adverse Events
Pamiparib
Serious events: 17 serious events
Other events: 65 other events
Deaths: 42 deaths
Placebo
Serious events: 11 serious events
Other events: 57 other events
Deaths: 31 deaths
Serious adverse events
| Measure |
Pamiparib
n=71 participants at risk
Participants received 60 mg pamiparib orally twice a day until progressive disease, unacceptable toxicity, death, or withdrawal of consent for study treatment, investigator's discretion, start of new anticancer therapy or Sponsor's decision to end the study
|
Placebo
n=65 participants at risk
Participants received 60 mg placebo orally twice daily until progressive disease, unacceptable toxicity, death, withdrawal of consent for study treatment, investigator's discretion, start of new anticancer therapy, or Sponsor's decision to end the study
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
4.2%
3/71 • Number of events 3 • From start of study treatment until 30 days after the last study drug intake or initiation of new anticancer therapy, whichever occurs first (up to approximately 4 years and 5.5 months)
Safety Analysis Set includes all participants in the ITT Analysis Set who receive at least one dose of study treatment (pamiparib or placebo).
|
1.5%
1/65 • Number of events 1 • From start of study treatment until 30 days after the last study drug intake or initiation of new anticancer therapy, whichever occurs first (up to approximately 4 years and 5.5 months)
Safety Analysis Set includes all participants in the ITT Analysis Set who receive at least one dose of study treatment (pamiparib or placebo).
|
|
Gastrointestinal disorders
Abdominal pain
|
1.4%
1/71 • Number of events 1 • From start of study treatment until 30 days after the last study drug intake or initiation of new anticancer therapy, whichever occurs first (up to approximately 4 years and 5.5 months)
Safety Analysis Set includes all participants in the ITT Analysis Set who receive at least one dose of study treatment (pamiparib or placebo).
|
0.00%
0/65 • From start of study treatment until 30 days after the last study drug intake or initiation of new anticancer therapy, whichever occurs first (up to approximately 4 years and 5.5 months)
Safety Analysis Set includes all participants in the ITT Analysis Set who receive at least one dose of study treatment (pamiparib or placebo).
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/71 • From start of study treatment until 30 days after the last study drug intake or initiation of new anticancer therapy, whichever occurs first (up to approximately 4 years and 5.5 months)
Safety Analysis Set includes all participants in the ITT Analysis Set who receive at least one dose of study treatment (pamiparib or placebo).
|
4.6%
3/65 • Number of events 3 • From start of study treatment until 30 days after the last study drug intake or initiation of new anticancer therapy, whichever occurs first (up to approximately 4 years and 5.5 months)
Safety Analysis Set includes all participants in the ITT Analysis Set who receive at least one dose of study treatment (pamiparib or placebo).
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.00%
0/71 • From start of study treatment until 30 days after the last study drug intake or initiation of new anticancer therapy, whichever occurs first (up to approximately 4 years and 5.5 months)
Safety Analysis Set includes all participants in the ITT Analysis Set who receive at least one dose of study treatment (pamiparib or placebo).
|
1.5%
1/65 • Number of events 2 • From start of study treatment until 30 days after the last study drug intake or initiation of new anticancer therapy, whichever occurs first (up to approximately 4 years and 5.5 months)
Safety Analysis Set includes all participants in the ITT Analysis Set who receive at least one dose of study treatment (pamiparib or placebo).
|
|
Gastrointestinal disorders
Intestinal obstruction
|
1.4%
1/71 • Number of events 1 • From start of study treatment until 30 days after the last study drug intake or initiation of new anticancer therapy, whichever occurs first (up to approximately 4 years and 5.5 months)
Safety Analysis Set includes all participants in the ITT Analysis Set who receive at least one dose of study treatment (pamiparib or placebo).
|
0.00%
0/65 • From start of study treatment until 30 days after the last study drug intake or initiation of new anticancer therapy, whichever occurs first (up to approximately 4 years and 5.5 months)
Safety Analysis Set includes all participants in the ITT Analysis Set who receive at least one dose of study treatment (pamiparib or placebo).
|
|
Gastrointestinal disorders
Malignant dysphagia
|
0.00%
0/71 • From start of study treatment until 30 days after the last study drug intake or initiation of new anticancer therapy, whichever occurs first (up to approximately 4 years and 5.5 months)
Safety Analysis Set includes all participants in the ITT Analysis Set who receive at least one dose of study treatment (pamiparib or placebo).
|
1.5%
1/65 • Number of events 1 • From start of study treatment until 30 days after the last study drug intake or initiation of new anticancer therapy, whichever occurs first (up to approximately 4 years and 5.5 months)
Safety Analysis Set includes all participants in the ITT Analysis Set who receive at least one dose of study treatment (pamiparib or placebo).
|
|
Gastrointestinal disorders
Obstruction gastric
|
0.00%
0/71 • From start of study treatment until 30 days after the last study drug intake or initiation of new anticancer therapy, whichever occurs first (up to approximately 4 years and 5.5 months)
Safety Analysis Set includes all participants in the ITT Analysis Set who receive at least one dose of study treatment (pamiparib or placebo).
|
3.1%
2/65 • Number of events 2 • From start of study treatment until 30 days after the last study drug intake or initiation of new anticancer therapy, whichever occurs first (up to approximately 4 years and 5.5 months)
Safety Analysis Set includes all participants in the ITT Analysis Set who receive at least one dose of study treatment (pamiparib or placebo).
|
|
Gastrointestinal disorders
Subileus
|
1.4%
1/71 • Number of events 1 • From start of study treatment until 30 days after the last study drug intake or initiation of new anticancer therapy, whichever occurs first (up to approximately 4 years and 5.5 months)
Safety Analysis Set includes all participants in the ITT Analysis Set who receive at least one dose of study treatment (pamiparib or placebo).
|
0.00%
0/65 • From start of study treatment until 30 days after the last study drug intake or initiation of new anticancer therapy, whichever occurs first (up to approximately 4 years and 5.5 months)
Safety Analysis Set includes all participants in the ITT Analysis Set who receive at least one dose of study treatment (pamiparib or placebo).
|
|
Gastrointestinal disorders
Upper gastrointestinal haemorrhage
|
1.4%
1/71 • Number of events 1 • From start of study treatment until 30 days after the last study drug intake or initiation of new anticancer therapy, whichever occurs first (up to approximately 4 years and 5.5 months)
Safety Analysis Set includes all participants in the ITT Analysis Set who receive at least one dose of study treatment (pamiparib or placebo).
|
1.5%
1/65 • Number of events 1 • From start of study treatment until 30 days after the last study drug intake or initiation of new anticancer therapy, whichever occurs first (up to approximately 4 years and 5.5 months)
Safety Analysis Set includes all participants in the ITT Analysis Set who receive at least one dose of study treatment (pamiparib or placebo).
|
|
Gastrointestinal disorders
Vomiting
|
2.8%
2/71 • Number of events 2 • From start of study treatment until 30 days after the last study drug intake or initiation of new anticancer therapy, whichever occurs first (up to approximately 4 years and 5.5 months)
Safety Analysis Set includes all participants in the ITT Analysis Set who receive at least one dose of study treatment (pamiparib or placebo).
|
0.00%
0/65 • From start of study treatment until 30 days after the last study drug intake or initiation of new anticancer therapy, whichever occurs first (up to approximately 4 years and 5.5 months)
Safety Analysis Set includes all participants in the ITT Analysis Set who receive at least one dose of study treatment (pamiparib or placebo).
|
|
General disorders
Death
|
2.8%
2/71 • Number of events 2 • From start of study treatment until 30 days after the last study drug intake or initiation of new anticancer therapy, whichever occurs first (up to approximately 4 years and 5.5 months)
Safety Analysis Set includes all participants in the ITT Analysis Set who receive at least one dose of study treatment (pamiparib or placebo).
|
0.00%
0/65 • From start of study treatment until 30 days after the last study drug intake or initiation of new anticancer therapy, whichever occurs first (up to approximately 4 years and 5.5 months)
Safety Analysis Set includes all participants in the ITT Analysis Set who receive at least one dose of study treatment (pamiparib or placebo).
|
|
General disorders
General physical health deterioration
|
1.4%
1/71 • Number of events 1 • From start of study treatment until 30 days after the last study drug intake or initiation of new anticancer therapy, whichever occurs first (up to approximately 4 years and 5.5 months)
Safety Analysis Set includes all participants in the ITT Analysis Set who receive at least one dose of study treatment (pamiparib or placebo).
|
0.00%
0/65 • From start of study treatment until 30 days after the last study drug intake or initiation of new anticancer therapy, whichever occurs first (up to approximately 4 years and 5.5 months)
Safety Analysis Set includes all participants in the ITT Analysis Set who receive at least one dose of study treatment (pamiparib or placebo).
|
|
Hepatobiliary disorders
Jaundice
|
1.4%
1/71 • Number of events 1 • From start of study treatment until 30 days after the last study drug intake or initiation of new anticancer therapy, whichever occurs first (up to approximately 4 years and 5.5 months)
Safety Analysis Set includes all participants in the ITT Analysis Set who receive at least one dose of study treatment (pamiparib or placebo).
|
0.00%
0/65 • From start of study treatment until 30 days after the last study drug intake or initiation of new anticancer therapy, whichever occurs first (up to approximately 4 years and 5.5 months)
Safety Analysis Set includes all participants in the ITT Analysis Set who receive at least one dose of study treatment (pamiparib or placebo).
|
|
Infections and infestations
Device related infection
|
1.4%
1/71 • Number of events 1 • From start of study treatment until 30 days after the last study drug intake or initiation of new anticancer therapy, whichever occurs first (up to approximately 4 years and 5.5 months)
Safety Analysis Set includes all participants in the ITT Analysis Set who receive at least one dose of study treatment (pamiparib or placebo).
|
0.00%
0/65 • From start of study treatment until 30 days after the last study drug intake or initiation of new anticancer therapy, whichever occurs first (up to approximately 4 years and 5.5 months)
Safety Analysis Set includes all participants in the ITT Analysis Set who receive at least one dose of study treatment (pamiparib or placebo).
|
|
Infections and infestations
Pneumocystis jirovecii infection
|
1.4%
1/71 • Number of events 1 • From start of study treatment until 30 days after the last study drug intake or initiation of new anticancer therapy, whichever occurs first (up to approximately 4 years and 5.5 months)
Safety Analysis Set includes all participants in the ITT Analysis Set who receive at least one dose of study treatment (pamiparib or placebo).
|
0.00%
0/65 • From start of study treatment until 30 days after the last study drug intake or initiation of new anticancer therapy, whichever occurs first (up to approximately 4 years and 5.5 months)
Safety Analysis Set includes all participants in the ITT Analysis Set who receive at least one dose of study treatment (pamiparib or placebo).
|
|
Infections and infestations
Pneumonia
|
2.8%
2/71 • Number of events 2 • From start of study treatment until 30 days after the last study drug intake or initiation of new anticancer therapy, whichever occurs first (up to approximately 4 years and 5.5 months)
Safety Analysis Set includes all participants in the ITT Analysis Set who receive at least one dose of study treatment (pamiparib or placebo).
|
1.5%
1/65 • Number of events 1 • From start of study treatment until 30 days after the last study drug intake or initiation of new anticancer therapy, whichever occurs first (up to approximately 4 years and 5.5 months)
Safety Analysis Set includes all participants in the ITT Analysis Set who receive at least one dose of study treatment (pamiparib or placebo).
|
|
Infections and infestations
Sepsis
|
0.00%
0/71 • From start of study treatment until 30 days after the last study drug intake or initiation of new anticancer therapy, whichever occurs first (up to approximately 4 years and 5.5 months)
Safety Analysis Set includes all participants in the ITT Analysis Set who receive at least one dose of study treatment (pamiparib or placebo).
|
1.5%
1/65 • Number of events 1 • From start of study treatment until 30 days after the last study drug intake or initiation of new anticancer therapy, whichever occurs first (up to approximately 4 years and 5.5 months)
Safety Analysis Set includes all participants in the ITT Analysis Set who receive at least one dose of study treatment (pamiparib or placebo).
|
|
Injury, poisoning and procedural complications
Hepatic rupture
|
0.00%
0/71 • From start of study treatment until 30 days after the last study drug intake or initiation of new anticancer therapy, whichever occurs first (up to approximately 4 years and 5.5 months)
Safety Analysis Set includes all participants in the ITT Analysis Set who receive at least one dose of study treatment (pamiparib or placebo).
|
1.5%
1/65 • Number of events 1 • From start of study treatment until 30 days after the last study drug intake or initiation of new anticancer therapy, whichever occurs first (up to approximately 4 years and 5.5 months)
Safety Analysis Set includes all participants in the ITT Analysis Set who receive at least one dose of study treatment (pamiparib or placebo).
|
|
Investigations
Platelet count decreased
|
1.4%
1/71 • Number of events 1 • From start of study treatment until 30 days after the last study drug intake or initiation of new anticancer therapy, whichever occurs first (up to approximately 4 years and 5.5 months)
Safety Analysis Set includes all participants in the ITT Analysis Set who receive at least one dose of study treatment (pamiparib or placebo).
|
0.00%
0/65 • From start of study treatment until 30 days after the last study drug intake or initiation of new anticancer therapy, whichever occurs first (up to approximately 4 years and 5.5 months)
Safety Analysis Set includes all participants in the ITT Analysis Set who receive at least one dose of study treatment (pamiparib or placebo).
|
|
Psychiatric disorders
Depression
|
1.4%
1/71 • Number of events 1 • From start of study treatment until 30 days after the last study drug intake or initiation of new anticancer therapy, whichever occurs first (up to approximately 4 years and 5.5 months)
Safety Analysis Set includes all participants in the ITT Analysis Set who receive at least one dose of study treatment (pamiparib or placebo).
|
0.00%
0/65 • From start of study treatment until 30 days after the last study drug intake or initiation of new anticancer therapy, whichever occurs first (up to approximately 4 years and 5.5 months)
Safety Analysis Set includes all participants in the ITT Analysis Set who receive at least one dose of study treatment (pamiparib or placebo).
|
|
Renal and urinary disorders
Acute kidney injury
|
1.4%
1/71 • Number of events 1 • From start of study treatment until 30 days after the last study drug intake or initiation of new anticancer therapy, whichever occurs first (up to approximately 4 years and 5.5 months)
Safety Analysis Set includes all participants in the ITT Analysis Set who receive at least one dose of study treatment (pamiparib or placebo).
|
0.00%
0/65 • From start of study treatment until 30 days after the last study drug intake or initiation of new anticancer therapy, whichever occurs first (up to approximately 4 years and 5.5 months)
Safety Analysis Set includes all participants in the ITT Analysis Set who receive at least one dose of study treatment (pamiparib or placebo).
|
|
Renal and urinary disorders
Postrenal failure
|
0.00%
0/71 • From start of study treatment until 30 days after the last study drug intake or initiation of new anticancer therapy, whichever occurs first (up to approximately 4 years and 5.5 months)
Safety Analysis Set includes all participants in the ITT Analysis Set who receive at least one dose of study treatment (pamiparib or placebo).
|
1.5%
1/65 • Number of events 1 • From start of study treatment until 30 days after the last study drug intake or initiation of new anticancer therapy, whichever occurs first (up to approximately 4 years and 5.5 months)
Safety Analysis Set includes all participants in the ITT Analysis Set who receive at least one dose of study treatment (pamiparib or placebo).
|
|
Renal and urinary disorders
Renal colic
|
1.4%
1/71 • Number of events 1 • From start of study treatment until 30 days after the last study drug intake or initiation of new anticancer therapy, whichever occurs first (up to approximately 4 years and 5.5 months)
Safety Analysis Set includes all participants in the ITT Analysis Set who receive at least one dose of study treatment (pamiparib or placebo).
|
0.00%
0/65 • From start of study treatment until 30 days after the last study drug intake or initiation of new anticancer therapy, whichever occurs first (up to approximately 4 years and 5.5 months)
Safety Analysis Set includes all participants in the ITT Analysis Set who receive at least one dose of study treatment (pamiparib or placebo).
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
1.4%
1/71 • Number of events 1 • From start of study treatment until 30 days after the last study drug intake or initiation of new anticancer therapy, whichever occurs first (up to approximately 4 years and 5.5 months)
Safety Analysis Set includes all participants in the ITT Analysis Set who receive at least one dose of study treatment (pamiparib or placebo).
|
0.00%
0/65 • From start of study treatment until 30 days after the last study drug intake or initiation of new anticancer therapy, whichever occurs first (up to approximately 4 years and 5.5 months)
Safety Analysis Set includes all participants in the ITT Analysis Set who receive at least one dose of study treatment (pamiparib or placebo).
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
1.4%
1/71 • Number of events 1 • From start of study treatment until 30 days after the last study drug intake or initiation of new anticancer therapy, whichever occurs first (up to approximately 4 years and 5.5 months)
Safety Analysis Set includes all participants in the ITT Analysis Set who receive at least one dose of study treatment (pamiparib or placebo).
|
0.00%
0/65 • From start of study treatment until 30 days after the last study drug intake or initiation of new anticancer therapy, whichever occurs first (up to approximately 4 years and 5.5 months)
Safety Analysis Set includes all participants in the ITT Analysis Set who receive at least one dose of study treatment (pamiparib or placebo).
|
|
Vascular disorders
Hypotension
|
1.4%
1/71 • Number of events 1 • From start of study treatment until 30 days after the last study drug intake or initiation of new anticancer therapy, whichever occurs first (up to approximately 4 years and 5.5 months)
Safety Analysis Set includes all participants in the ITT Analysis Set who receive at least one dose of study treatment (pamiparib or placebo).
|
0.00%
0/65 • From start of study treatment until 30 days after the last study drug intake or initiation of new anticancer therapy, whichever occurs first (up to approximately 4 years and 5.5 months)
Safety Analysis Set includes all participants in the ITT Analysis Set who receive at least one dose of study treatment (pamiparib or placebo).
|
Other adverse events
| Measure |
Pamiparib
n=71 participants at risk
Participants received 60 mg pamiparib orally twice a day until progressive disease, unacceptable toxicity, death, or withdrawal of consent for study treatment, investigator's discretion, start of new anticancer therapy or Sponsor's decision to end the study
|
Placebo
n=65 participants at risk
Participants received 60 mg placebo orally twice daily until progressive disease, unacceptable toxicity, death, withdrawal of consent for study treatment, investigator's discretion, start of new anticancer therapy, or Sponsor's decision to end the study
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
35.2%
25/71 • Number of events 31 • From start of study treatment until 30 days after the last study drug intake or initiation of new anticancer therapy, whichever occurs first (up to approximately 4 years and 5.5 months)
Safety Analysis Set includes all participants in the ITT Analysis Set who receive at least one dose of study treatment (pamiparib or placebo).
|
15.4%
10/65 • Number of events 12 • From start of study treatment until 30 days after the last study drug intake or initiation of new anticancer therapy, whichever occurs first (up to approximately 4 years and 5.5 months)
Safety Analysis Set includes all participants in the ITT Analysis Set who receive at least one dose of study treatment (pamiparib or placebo).
|
|
Blood and lymphatic system disorders
Leukopenia
|
4.2%
3/71 • Number of events 5 • From start of study treatment until 30 days after the last study drug intake or initiation of new anticancer therapy, whichever occurs first (up to approximately 4 years and 5.5 months)
Safety Analysis Set includes all participants in the ITT Analysis Set who receive at least one dose of study treatment (pamiparib or placebo).
|
1.5%
1/65 • Number of events 1 • From start of study treatment until 30 days after the last study drug intake or initiation of new anticancer therapy, whichever occurs first (up to approximately 4 years and 5.5 months)
Safety Analysis Set includes all participants in the ITT Analysis Set who receive at least one dose of study treatment (pamiparib or placebo).
|
|
Blood and lymphatic system disorders
Lymphopenia
|
5.6%
4/71 • Number of events 4 • From start of study treatment until 30 days after the last study drug intake or initiation of new anticancer therapy, whichever occurs first (up to approximately 4 years and 5.5 months)
Safety Analysis Set includes all participants in the ITT Analysis Set who receive at least one dose of study treatment (pamiparib or placebo).
|
0.00%
0/65 • From start of study treatment until 30 days after the last study drug intake or initiation of new anticancer therapy, whichever occurs first (up to approximately 4 years and 5.5 months)
Safety Analysis Set includes all participants in the ITT Analysis Set who receive at least one dose of study treatment (pamiparib or placebo).
|
|
Blood and lymphatic system disorders
Neutropenia
|
7.0%
5/71 • Number of events 8 • From start of study treatment until 30 days after the last study drug intake or initiation of new anticancer therapy, whichever occurs first (up to approximately 4 years and 5.5 months)
Safety Analysis Set includes all participants in the ITT Analysis Set who receive at least one dose of study treatment (pamiparib or placebo).
|
4.6%
3/65 • Number of events 4 • From start of study treatment until 30 days after the last study drug intake or initiation of new anticancer therapy, whichever occurs first (up to approximately 4 years and 5.5 months)
Safety Analysis Set includes all participants in the ITT Analysis Set who receive at least one dose of study treatment (pamiparib or placebo).
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
5.6%
4/71 • Number of events 7 • From start of study treatment until 30 days after the last study drug intake or initiation of new anticancer therapy, whichever occurs first (up to approximately 4 years and 5.5 months)
Safety Analysis Set includes all participants in the ITT Analysis Set who receive at least one dose of study treatment (pamiparib or placebo).
|
7.7%
5/65 • Number of events 7 • From start of study treatment until 30 days after the last study drug intake or initiation of new anticancer therapy, whichever occurs first (up to approximately 4 years and 5.5 months)
Safety Analysis Set includes all participants in the ITT Analysis Set who receive at least one dose of study treatment (pamiparib or placebo).
|
|
Gastrointestinal disorders
Abdominal distension
|
5.6%
4/71 • Number of events 5 • From start of study treatment until 30 days after the last study drug intake or initiation of new anticancer therapy, whichever occurs first (up to approximately 4 years and 5.5 months)
Safety Analysis Set includes all participants in the ITT Analysis Set who receive at least one dose of study treatment (pamiparib or placebo).
|
4.6%
3/65 • Number of events 3 • From start of study treatment until 30 days after the last study drug intake or initiation of new anticancer therapy, whichever occurs first (up to approximately 4 years and 5.5 months)
Safety Analysis Set includes all participants in the ITT Analysis Set who receive at least one dose of study treatment (pamiparib or placebo).
|
|
Gastrointestinal disorders
Abdominal pain
|
12.7%
9/71 • Number of events 9 • From start of study treatment until 30 days after the last study drug intake or initiation of new anticancer therapy, whichever occurs first (up to approximately 4 years and 5.5 months)
Safety Analysis Set includes all participants in the ITT Analysis Set who receive at least one dose of study treatment (pamiparib or placebo).
|
20.0%
13/65 • Number of events 14 • From start of study treatment until 30 days after the last study drug intake or initiation of new anticancer therapy, whichever occurs first (up to approximately 4 years and 5.5 months)
Safety Analysis Set includes all participants in the ITT Analysis Set who receive at least one dose of study treatment (pamiparib or placebo).
|
|
Gastrointestinal disorders
Abdominal pain upper
|
16.9%
12/71 • Number of events 13 • From start of study treatment until 30 days after the last study drug intake or initiation of new anticancer therapy, whichever occurs first (up to approximately 4 years and 5.5 months)
Safety Analysis Set includes all participants in the ITT Analysis Set who receive at least one dose of study treatment (pamiparib or placebo).
|
10.8%
7/65 • Number of events 7 • From start of study treatment until 30 days after the last study drug intake or initiation of new anticancer therapy, whichever occurs first (up to approximately 4 years and 5.5 months)
Safety Analysis Set includes all participants in the ITT Analysis Set who receive at least one dose of study treatment (pamiparib or placebo).
|
|
Gastrointestinal disorders
Constipation
|
12.7%
9/71 • Number of events 13 • From start of study treatment until 30 days after the last study drug intake or initiation of new anticancer therapy, whichever occurs first (up to approximately 4 years and 5.5 months)
Safety Analysis Set includes all participants in the ITT Analysis Set who receive at least one dose of study treatment (pamiparib or placebo).
|
13.8%
9/65 • Number of events 9 • From start of study treatment until 30 days after the last study drug intake or initiation of new anticancer therapy, whichever occurs first (up to approximately 4 years and 5.5 months)
Safety Analysis Set includes all participants in the ITT Analysis Set who receive at least one dose of study treatment (pamiparib or placebo).
|
|
Gastrointestinal disorders
Diarrhoea
|
18.3%
13/71 • Number of events 21 • From start of study treatment until 30 days after the last study drug intake or initiation of new anticancer therapy, whichever occurs first (up to approximately 4 years and 5.5 months)
Safety Analysis Set includes all participants in the ITT Analysis Set who receive at least one dose of study treatment (pamiparib or placebo).
|
13.8%
9/65 • Number of events 10 • From start of study treatment until 30 days after the last study drug intake or initiation of new anticancer therapy, whichever occurs first (up to approximately 4 years and 5.5 months)
Safety Analysis Set includes all participants in the ITT Analysis Set who receive at least one dose of study treatment (pamiparib or placebo).
|
|
Gastrointestinal disorders
Dysphagia
|
4.2%
3/71 • Number of events 3 • From start of study treatment until 30 days after the last study drug intake or initiation of new anticancer therapy, whichever occurs first (up to approximately 4 years and 5.5 months)
Safety Analysis Set includes all participants in the ITT Analysis Set who receive at least one dose of study treatment (pamiparib or placebo).
|
10.8%
7/65 • Number of events 7 • From start of study treatment until 30 days after the last study drug intake or initiation of new anticancer therapy, whichever occurs first (up to approximately 4 years and 5.5 months)
Safety Analysis Set includes all participants in the ITT Analysis Set who receive at least one dose of study treatment (pamiparib or placebo).
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
5.6%
4/71 • Number of events 4 • From start of study treatment until 30 days after the last study drug intake or initiation of new anticancer therapy, whichever occurs first (up to approximately 4 years and 5.5 months)
Safety Analysis Set includes all participants in the ITT Analysis Set who receive at least one dose of study treatment (pamiparib or placebo).
|
4.6%
3/65 • Number of events 3 • From start of study treatment until 30 days after the last study drug intake or initiation of new anticancer therapy, whichever occurs first (up to approximately 4 years and 5.5 months)
Safety Analysis Set includes all participants in the ITT Analysis Set who receive at least one dose of study treatment (pamiparib or placebo).
|
|
Gastrointestinal disorders
Nausea
|
32.4%
23/71 • Number of events 26 • From start of study treatment until 30 days after the last study drug intake or initiation of new anticancer therapy, whichever occurs first (up to approximately 4 years and 5.5 months)
Safety Analysis Set includes all participants in the ITT Analysis Set who receive at least one dose of study treatment (pamiparib or placebo).
|
18.5%
12/65 • Number of events 14 • From start of study treatment until 30 days after the last study drug intake or initiation of new anticancer therapy, whichever occurs first (up to approximately 4 years and 5.5 months)
Safety Analysis Set includes all participants in the ITT Analysis Set who receive at least one dose of study treatment (pamiparib or placebo).
|
|
Gastrointestinal disorders
Odynophagia
|
1.4%
1/71 • Number of events 1 • From start of study treatment until 30 days after the last study drug intake or initiation of new anticancer therapy, whichever occurs first (up to approximately 4 years and 5.5 months)
Safety Analysis Set includes all participants in the ITT Analysis Set who receive at least one dose of study treatment (pamiparib or placebo).
|
3.1%
2/65 • Number of events 2 • From start of study treatment until 30 days after the last study drug intake or initiation of new anticancer therapy, whichever occurs first (up to approximately 4 years and 5.5 months)
Safety Analysis Set includes all participants in the ITT Analysis Set who receive at least one dose of study treatment (pamiparib or placebo).
|
|
Gastrointestinal disorders
Stomatitis
|
4.2%
3/71 • Number of events 4 • From start of study treatment until 30 days after the last study drug intake or initiation of new anticancer therapy, whichever occurs first (up to approximately 4 years and 5.5 months)
Safety Analysis Set includes all participants in the ITT Analysis Set who receive at least one dose of study treatment (pamiparib or placebo).
|
4.6%
3/65 • Number of events 3 • From start of study treatment until 30 days after the last study drug intake or initiation of new anticancer therapy, whichever occurs first (up to approximately 4 years and 5.5 months)
Safety Analysis Set includes all participants in the ITT Analysis Set who receive at least one dose of study treatment (pamiparib or placebo).
|
|
Gastrointestinal disorders
Vomiting
|
22.5%
16/71 • Number of events 17 • From start of study treatment until 30 days after the last study drug intake or initiation of new anticancer therapy, whichever occurs first (up to approximately 4 years and 5.5 months)
Safety Analysis Set includes all participants in the ITT Analysis Set who receive at least one dose of study treatment (pamiparib or placebo).
|
3.1%
2/65 • Number of events 2 • From start of study treatment until 30 days after the last study drug intake or initiation of new anticancer therapy, whichever occurs first (up to approximately 4 years and 5.5 months)
Safety Analysis Set includes all participants in the ITT Analysis Set who receive at least one dose of study treatment (pamiparib or placebo).
|
|
General disorders
Asthenia
|
22.5%
16/71 • Number of events 16 • From start of study treatment until 30 days after the last study drug intake or initiation of new anticancer therapy, whichever occurs first (up to approximately 4 years and 5.5 months)
Safety Analysis Set includes all participants in the ITT Analysis Set who receive at least one dose of study treatment (pamiparib or placebo).
|
18.5%
12/65 • Number of events 12 • From start of study treatment until 30 days after the last study drug intake or initiation of new anticancer therapy, whichever occurs first (up to approximately 4 years and 5.5 months)
Safety Analysis Set includes all participants in the ITT Analysis Set who receive at least one dose of study treatment (pamiparib or placebo).
|
|
General disorders
Chest pain
|
4.2%
3/71 • Number of events 5 • From start of study treatment until 30 days after the last study drug intake or initiation of new anticancer therapy, whichever occurs first (up to approximately 4 years and 5.5 months)
Safety Analysis Set includes all participants in the ITT Analysis Set who receive at least one dose of study treatment (pamiparib or placebo).
|
0.00%
0/65 • From start of study treatment until 30 days after the last study drug intake or initiation of new anticancer therapy, whichever occurs first (up to approximately 4 years and 5.5 months)
Safety Analysis Set includes all participants in the ITT Analysis Set who receive at least one dose of study treatment (pamiparib or placebo).
|
|
General disorders
Fatigue
|
5.6%
4/71 • Number of events 4 • From start of study treatment until 30 days after the last study drug intake or initiation of new anticancer therapy, whichever occurs first (up to approximately 4 years and 5.5 months)
Safety Analysis Set includes all participants in the ITT Analysis Set who receive at least one dose of study treatment (pamiparib or placebo).
|
6.2%
4/65 • Number of events 4 • From start of study treatment until 30 days after the last study drug intake or initiation of new anticancer therapy, whichever occurs first (up to approximately 4 years and 5.5 months)
Safety Analysis Set includes all participants in the ITT Analysis Set who receive at least one dose of study treatment (pamiparib or placebo).
|
|
General disorders
Malaise
|
5.6%
4/71 • Number of events 4 • From start of study treatment until 30 days after the last study drug intake or initiation of new anticancer therapy, whichever occurs first (up to approximately 4 years and 5.5 months)
Safety Analysis Set includes all participants in the ITT Analysis Set who receive at least one dose of study treatment (pamiparib or placebo).
|
3.1%
2/65 • Number of events 2 • From start of study treatment until 30 days after the last study drug intake or initiation of new anticancer therapy, whichever occurs first (up to approximately 4 years and 5.5 months)
Safety Analysis Set includes all participants in the ITT Analysis Set who receive at least one dose of study treatment (pamiparib or placebo).
|
|
General disorders
Oedema peripheral
|
7.0%
5/71 • Number of events 5 • From start of study treatment until 30 days after the last study drug intake or initiation of new anticancer therapy, whichever occurs first (up to approximately 4 years and 5.5 months)
Safety Analysis Set includes all participants in the ITT Analysis Set who receive at least one dose of study treatment (pamiparib or placebo).
|
6.2%
4/65 • Number of events 4 • From start of study treatment until 30 days after the last study drug intake or initiation of new anticancer therapy, whichever occurs first (up to approximately 4 years and 5.5 months)
Safety Analysis Set includes all participants in the ITT Analysis Set who receive at least one dose of study treatment (pamiparib or placebo).
|
|
General disorders
Pyrexia
|
8.5%
6/71 • Number of events 6 • From start of study treatment until 30 days after the last study drug intake or initiation of new anticancer therapy, whichever occurs first (up to approximately 4 years and 5.5 months)
Safety Analysis Set includes all participants in the ITT Analysis Set who receive at least one dose of study treatment (pamiparib or placebo).
|
1.5%
1/65 • Number of events 1 • From start of study treatment until 30 days after the last study drug intake or initiation of new anticancer therapy, whichever occurs first (up to approximately 4 years and 5.5 months)
Safety Analysis Set includes all participants in the ITT Analysis Set who receive at least one dose of study treatment (pamiparib or placebo).
|
|
Infections and infestations
Gastroenteritis viral
|
0.00%
0/71 • From start of study treatment until 30 days after the last study drug intake or initiation of new anticancer therapy, whichever occurs first (up to approximately 4 years and 5.5 months)
Safety Analysis Set includes all participants in the ITT Analysis Set who receive at least one dose of study treatment (pamiparib or placebo).
|
3.1%
2/65 • Number of events 2 • From start of study treatment until 30 days after the last study drug intake or initiation of new anticancer therapy, whichever occurs first (up to approximately 4 years and 5.5 months)
Safety Analysis Set includes all participants in the ITT Analysis Set who receive at least one dose of study treatment (pamiparib or placebo).
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/71 • From start of study treatment until 30 days after the last study drug intake or initiation of new anticancer therapy, whichever occurs first (up to approximately 4 years and 5.5 months)
Safety Analysis Set includes all participants in the ITT Analysis Set who receive at least one dose of study treatment (pamiparib or placebo).
|
3.1%
2/65 • Number of events 2 • From start of study treatment until 30 days after the last study drug intake or initiation of new anticancer therapy, whichever occurs first (up to approximately 4 years and 5.5 months)
Safety Analysis Set includes all participants in the ITT Analysis Set who receive at least one dose of study treatment (pamiparib or placebo).
|
|
Infections and infestations
Pneumonia
|
0.00%
0/71 • From start of study treatment until 30 days after the last study drug intake or initiation of new anticancer therapy, whichever occurs first (up to approximately 4 years and 5.5 months)
Safety Analysis Set includes all participants in the ITT Analysis Set who receive at least one dose of study treatment (pamiparib or placebo).
|
3.1%
2/65 • Number of events 2 • From start of study treatment until 30 days after the last study drug intake or initiation of new anticancer therapy, whichever occurs first (up to approximately 4 years and 5.5 months)
Safety Analysis Set includes all participants in the ITT Analysis Set who receive at least one dose of study treatment (pamiparib or placebo).
|
|
Infections and infestations
Upper respiratory tract infection
|
5.6%
4/71 • Number of events 5 • From start of study treatment until 30 days after the last study drug intake or initiation of new anticancer therapy, whichever occurs first (up to approximately 4 years and 5.5 months)
Safety Analysis Set includes all participants in the ITT Analysis Set who receive at least one dose of study treatment (pamiparib or placebo).
|
3.1%
2/65 • Number of events 3 • From start of study treatment until 30 days after the last study drug intake or initiation of new anticancer therapy, whichever occurs first (up to approximately 4 years and 5.5 months)
Safety Analysis Set includes all participants in the ITT Analysis Set who receive at least one dose of study treatment (pamiparib or placebo).
|
|
Investigations
Alanine aminotransferase increased
|
11.3%
8/71 • Number of events 9 • From start of study treatment until 30 days after the last study drug intake or initiation of new anticancer therapy, whichever occurs first (up to approximately 4 years and 5.5 months)
Safety Analysis Set includes all participants in the ITT Analysis Set who receive at least one dose of study treatment (pamiparib or placebo).
|
7.7%
5/65 • Number of events 6 • From start of study treatment until 30 days after the last study drug intake or initiation of new anticancer therapy, whichever occurs first (up to approximately 4 years and 5.5 months)
Safety Analysis Set includes all participants in the ITT Analysis Set who receive at least one dose of study treatment (pamiparib or placebo).
|
|
Investigations
Aspartate aminotransferase increased
|
12.7%
9/71 • Number of events 11 • From start of study treatment until 30 days after the last study drug intake or initiation of new anticancer therapy, whichever occurs first (up to approximately 4 years and 5.5 months)
Safety Analysis Set includes all participants in the ITT Analysis Set who receive at least one dose of study treatment (pamiparib or placebo).
|
7.7%
5/65 • Number of events 6 • From start of study treatment until 30 days after the last study drug intake or initiation of new anticancer therapy, whichever occurs first (up to approximately 4 years and 5.5 months)
Safety Analysis Set includes all participants in the ITT Analysis Set who receive at least one dose of study treatment (pamiparib or placebo).
|
|
Investigations
Blood alkaline phosphatase increased
|
8.5%
6/71 • Number of events 6 • From start of study treatment until 30 days after the last study drug intake or initiation of new anticancer therapy, whichever occurs first (up to approximately 4 years and 5.5 months)
Safety Analysis Set includes all participants in the ITT Analysis Set who receive at least one dose of study treatment (pamiparib or placebo).
|
6.2%
4/65 • Number of events 6 • From start of study treatment until 30 days after the last study drug intake or initiation of new anticancer therapy, whichever occurs first (up to approximately 4 years and 5.5 months)
Safety Analysis Set includes all participants in the ITT Analysis Set who receive at least one dose of study treatment (pamiparib or placebo).
|
|
Investigations
Blood bilirubin increased
|
4.2%
3/71 • Number of events 4 • From start of study treatment until 30 days after the last study drug intake or initiation of new anticancer therapy, whichever occurs first (up to approximately 4 years and 5.5 months)
Safety Analysis Set includes all participants in the ITT Analysis Set who receive at least one dose of study treatment (pamiparib or placebo).
|
1.5%
1/65 • Number of events 2 • From start of study treatment until 30 days after the last study drug intake or initiation of new anticancer therapy, whichever occurs first (up to approximately 4 years and 5.5 months)
Safety Analysis Set includes all participants in the ITT Analysis Set who receive at least one dose of study treatment (pamiparib or placebo).
|
|
Investigations
Blood creatinine increased
|
7.0%
5/71 • Number of events 5 • From start of study treatment until 30 days after the last study drug intake or initiation of new anticancer therapy, whichever occurs first (up to approximately 4 years and 5.5 months)
Safety Analysis Set includes all participants in the ITT Analysis Set who receive at least one dose of study treatment (pamiparib or placebo).
|
3.1%
2/65 • Number of events 2 • From start of study treatment until 30 days after the last study drug intake or initiation of new anticancer therapy, whichever occurs first (up to approximately 4 years and 5.5 months)
Safety Analysis Set includes all participants in the ITT Analysis Set who receive at least one dose of study treatment (pamiparib or placebo).
|
|
Investigations
Blood lactate dehydrogenase increased
|
5.6%
4/71 • Number of events 4 • From start of study treatment until 30 days after the last study drug intake or initiation of new anticancer therapy, whichever occurs first (up to approximately 4 years and 5.5 months)
Safety Analysis Set includes all participants in the ITT Analysis Set who receive at least one dose of study treatment (pamiparib or placebo).
|
4.6%
3/65 • Number of events 3 • From start of study treatment until 30 days after the last study drug intake or initiation of new anticancer therapy, whichever occurs first (up to approximately 4 years and 5.5 months)
Safety Analysis Set includes all participants in the ITT Analysis Set who receive at least one dose of study treatment (pamiparib or placebo).
|
|
Investigations
Lymphocyte count decreased
|
5.6%
4/71 • Number of events 4 • From start of study treatment until 30 days after the last study drug intake or initiation of new anticancer therapy, whichever occurs first (up to approximately 4 years and 5.5 months)
Safety Analysis Set includes all participants in the ITT Analysis Set who receive at least one dose of study treatment (pamiparib or placebo).
|
1.5%
1/65 • Number of events 3 • From start of study treatment until 30 days after the last study drug intake or initiation of new anticancer therapy, whichever occurs first (up to approximately 4 years and 5.5 months)
Safety Analysis Set includes all participants in the ITT Analysis Set who receive at least one dose of study treatment (pamiparib or placebo).
|
|
Investigations
Neutrophil count decreased
|
9.9%
7/71 • Number of events 17 • From start of study treatment until 30 days after the last study drug intake or initiation of new anticancer therapy, whichever occurs first (up to approximately 4 years and 5.5 months)
Safety Analysis Set includes all participants in the ITT Analysis Set who receive at least one dose of study treatment (pamiparib or placebo).
|
4.6%
3/65 • Number of events 4 • From start of study treatment until 30 days after the last study drug intake or initiation of new anticancer therapy, whichever occurs first (up to approximately 4 years and 5.5 months)
Safety Analysis Set includes all participants in the ITT Analysis Set who receive at least one dose of study treatment (pamiparib or placebo).
|
|
Investigations
Platelet count decreased
|
11.3%
8/71 • Number of events 10 • From start of study treatment until 30 days after the last study drug intake or initiation of new anticancer therapy, whichever occurs first (up to approximately 4 years and 5.5 months)
Safety Analysis Set includes all participants in the ITT Analysis Set who receive at least one dose of study treatment (pamiparib or placebo).
|
3.1%
2/65 • Number of events 3 • From start of study treatment until 30 days after the last study drug intake or initiation of new anticancer therapy, whichever occurs first (up to approximately 4 years and 5.5 months)
Safety Analysis Set includes all participants in the ITT Analysis Set who receive at least one dose of study treatment (pamiparib or placebo).
|
|
Investigations
Weight decreased
|
12.7%
9/71 • Number of events 9 • From start of study treatment until 30 days after the last study drug intake or initiation of new anticancer therapy, whichever occurs first (up to approximately 4 years and 5.5 months)
Safety Analysis Set includes all participants in the ITT Analysis Set who receive at least one dose of study treatment (pamiparib or placebo).
|
3.1%
2/65 • Number of events 2 • From start of study treatment until 30 days after the last study drug intake or initiation of new anticancer therapy, whichever occurs first (up to approximately 4 years and 5.5 months)
Safety Analysis Set includes all participants in the ITT Analysis Set who receive at least one dose of study treatment (pamiparib or placebo).
|
|
Investigations
Weight increased
|
0.00%
0/71 • From start of study treatment until 30 days after the last study drug intake or initiation of new anticancer therapy, whichever occurs first (up to approximately 4 years and 5.5 months)
Safety Analysis Set includes all participants in the ITT Analysis Set who receive at least one dose of study treatment (pamiparib or placebo).
|
3.1%
2/65 • Number of events 2 • From start of study treatment until 30 days after the last study drug intake or initiation of new anticancer therapy, whichever occurs first (up to approximately 4 years and 5.5 months)
Safety Analysis Set includes all participants in the ITT Analysis Set who receive at least one dose of study treatment (pamiparib or placebo).
|
|
Investigations
White blood cell count decreased
|
11.3%
8/71 • Number of events 16 • From start of study treatment until 30 days after the last study drug intake or initiation of new anticancer therapy, whichever occurs first (up to approximately 4 years and 5.5 months)
Safety Analysis Set includes all participants in the ITT Analysis Set who receive at least one dose of study treatment (pamiparib or placebo).
|
4.6%
3/65 • Number of events 6 • From start of study treatment until 30 days after the last study drug intake or initiation of new anticancer therapy, whichever occurs first (up to approximately 4 years and 5.5 months)
Safety Analysis Set includes all participants in the ITT Analysis Set who receive at least one dose of study treatment (pamiparib or placebo).
|
|
Metabolism and nutrition disorders
Decreased appetite
|
26.8%
19/71 • Number of events 21 • From start of study treatment until 30 days after the last study drug intake or initiation of new anticancer therapy, whichever occurs first (up to approximately 4 years and 5.5 months)
Safety Analysis Set includes all participants in the ITT Analysis Set who receive at least one dose of study treatment (pamiparib or placebo).
|
13.8%
9/65 • Number of events 11 • From start of study treatment until 30 days after the last study drug intake or initiation of new anticancer therapy, whichever occurs first (up to approximately 4 years and 5.5 months)
Safety Analysis Set includes all participants in the ITT Analysis Set who receive at least one dose of study treatment (pamiparib or placebo).
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
9.9%
7/71 • Number of events 8 • From start of study treatment until 30 days after the last study drug intake or initiation of new anticancer therapy, whichever occurs first (up to approximately 4 years and 5.5 months)
Safety Analysis Set includes all participants in the ITT Analysis Set who receive at least one dose of study treatment (pamiparib or placebo).
|
4.6%
3/65 • Number of events 3 • From start of study treatment until 30 days after the last study drug intake or initiation of new anticancer therapy, whichever occurs first (up to approximately 4 years and 5.5 months)
Safety Analysis Set includes all participants in the ITT Analysis Set who receive at least one dose of study treatment (pamiparib or placebo).
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
4.2%
3/71 • Number of events 3 • From start of study treatment until 30 days after the last study drug intake or initiation of new anticancer therapy, whichever occurs first (up to approximately 4 years and 5.5 months)
Safety Analysis Set includes all participants in the ITT Analysis Set who receive at least one dose of study treatment (pamiparib or placebo).
|
10.8%
7/65 • Number of events 7 • From start of study treatment until 30 days after the last study drug intake or initiation of new anticancer therapy, whichever occurs first (up to approximately 4 years and 5.5 months)
Safety Analysis Set includes all participants in the ITT Analysis Set who receive at least one dose of study treatment (pamiparib or placebo).
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
1.4%
1/71 • Number of events 1 • From start of study treatment until 30 days after the last study drug intake or initiation of new anticancer therapy, whichever occurs first (up to approximately 4 years and 5.5 months)
Safety Analysis Set includes all participants in the ITT Analysis Set who receive at least one dose of study treatment (pamiparib or placebo).
|
3.1%
2/65 • Number of events 2 • From start of study treatment until 30 days after the last study drug intake or initiation of new anticancer therapy, whichever occurs first (up to approximately 4 years and 5.5 months)
Safety Analysis Set includes all participants in the ITT Analysis Set who receive at least one dose of study treatment (pamiparib or placebo).
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.00%
0/71 • From start of study treatment until 30 days after the last study drug intake or initiation of new anticancer therapy, whichever occurs first (up to approximately 4 years and 5.5 months)
Safety Analysis Set includes all participants in the ITT Analysis Set who receive at least one dose of study treatment (pamiparib or placebo).
|
3.1%
2/65 • Number of events 2 • From start of study treatment until 30 days after the last study drug intake or initiation of new anticancer therapy, whichever occurs first (up to approximately 4 years and 5.5 months)
Safety Analysis Set includes all participants in the ITT Analysis Set who receive at least one dose of study treatment (pamiparib or placebo).
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
1.4%
1/71 • Number of events 1 • From start of study treatment until 30 days after the last study drug intake or initiation of new anticancer therapy, whichever occurs first (up to approximately 4 years and 5.5 months)
Safety Analysis Set includes all participants in the ITT Analysis Set who receive at least one dose of study treatment (pamiparib or placebo).
|
3.1%
2/65 • Number of events 2 • From start of study treatment until 30 days after the last study drug intake or initiation of new anticancer therapy, whichever occurs first (up to approximately 4 years and 5.5 months)
Safety Analysis Set includes all participants in the ITT Analysis Set who receive at least one dose of study treatment (pamiparib or placebo).
|
|
Nervous system disorders
Dizziness
|
4.2%
3/71 • Number of events 3 • From start of study treatment until 30 days after the last study drug intake or initiation of new anticancer therapy, whichever occurs first (up to approximately 4 years and 5.5 months)
Safety Analysis Set includes all participants in the ITT Analysis Set who receive at least one dose of study treatment (pamiparib or placebo).
|
0.00%
0/65 • From start of study treatment until 30 days after the last study drug intake or initiation of new anticancer therapy, whichever occurs first (up to approximately 4 years and 5.5 months)
Safety Analysis Set includes all participants in the ITT Analysis Set who receive at least one dose of study treatment (pamiparib or placebo).
|
|
Nervous system disorders
Dysgeusia
|
8.5%
6/71 • Number of events 6 • From start of study treatment until 30 days after the last study drug intake or initiation of new anticancer therapy, whichever occurs first (up to approximately 4 years and 5.5 months)
Safety Analysis Set includes all participants in the ITT Analysis Set who receive at least one dose of study treatment (pamiparib or placebo).
|
3.1%
2/65 • Number of events 2 • From start of study treatment until 30 days after the last study drug intake or initiation of new anticancer therapy, whichever occurs first (up to approximately 4 years and 5.5 months)
Safety Analysis Set includes all participants in the ITT Analysis Set who receive at least one dose of study treatment (pamiparib or placebo).
|
|
Nervous system disorders
Headache
|
2.8%
2/71 • Number of events 2 • From start of study treatment until 30 days after the last study drug intake or initiation of new anticancer therapy, whichever occurs first (up to approximately 4 years and 5.5 months)
Safety Analysis Set includes all participants in the ITT Analysis Set who receive at least one dose of study treatment (pamiparib or placebo).
|
3.1%
2/65 • Number of events 2 • From start of study treatment until 30 days after the last study drug intake or initiation of new anticancer therapy, whichever occurs first (up to approximately 4 years and 5.5 months)
Safety Analysis Set includes all participants in the ITT Analysis Set who receive at least one dose of study treatment (pamiparib or placebo).
|
|
Nervous system disorders
Paraesthesia
|
1.4%
1/71 • Number of events 2 • From start of study treatment until 30 days after the last study drug intake or initiation of new anticancer therapy, whichever occurs first (up to approximately 4 years and 5.5 months)
Safety Analysis Set includes all participants in the ITT Analysis Set who receive at least one dose of study treatment (pamiparib or placebo).
|
4.6%
3/65 • Number of events 4 • From start of study treatment until 30 days after the last study drug intake or initiation of new anticancer therapy, whichever occurs first (up to approximately 4 years and 5.5 months)
Safety Analysis Set includes all participants in the ITT Analysis Set who receive at least one dose of study treatment (pamiparib or placebo).
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
5.6%
4/71 • Number of events 4 • From start of study treatment until 30 days after the last study drug intake or initiation of new anticancer therapy, whichever occurs first (up to approximately 4 years and 5.5 months)
Safety Analysis Set includes all participants in the ITT Analysis Set who receive at least one dose of study treatment (pamiparib or placebo).
|
13.8%
9/65 • Number of events 10 • From start of study treatment until 30 days after the last study drug intake or initiation of new anticancer therapy, whichever occurs first (up to approximately 4 years and 5.5 months)
Safety Analysis Set includes all participants in the ITT Analysis Set who receive at least one dose of study treatment (pamiparib or placebo).
|
|
Psychiatric disorders
Insomnia
|
4.2%
3/71 • Number of events 3 • From start of study treatment until 30 days after the last study drug intake or initiation of new anticancer therapy, whichever occurs first (up to approximately 4 years and 5.5 months)
Safety Analysis Set includes all participants in the ITT Analysis Set who receive at least one dose of study treatment (pamiparib or placebo).
|
7.7%
5/65 • Number of events 5 • From start of study treatment until 30 days after the last study drug intake or initiation of new anticancer therapy, whichever occurs first (up to approximately 4 years and 5.5 months)
Safety Analysis Set includes all participants in the ITT Analysis Set who receive at least one dose of study treatment (pamiparib or placebo).
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
4.2%
3/71 • Number of events 3 • From start of study treatment until 30 days after the last study drug intake or initiation of new anticancer therapy, whichever occurs first (up to approximately 4 years and 5.5 months)
Safety Analysis Set includes all participants in the ITT Analysis Set who receive at least one dose of study treatment (pamiparib or placebo).
|
3.1%
2/65 • Number of events 2 • From start of study treatment until 30 days after the last study drug intake or initiation of new anticancer therapy, whichever occurs first (up to approximately 4 years and 5.5 months)
Safety Analysis Set includes all participants in the ITT Analysis Set who receive at least one dose of study treatment (pamiparib or placebo).
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
0.00%
0/71 • From start of study treatment until 30 days after the last study drug intake or initiation of new anticancer therapy, whichever occurs first (up to approximately 4 years and 5.5 months)
Safety Analysis Set includes all participants in the ITT Analysis Set who receive at least one dose of study treatment (pamiparib or placebo).
|
3.1%
2/65 • Number of events 2 • From start of study treatment until 30 days after the last study drug intake or initiation of new anticancer therapy, whichever occurs first (up to approximately 4 years and 5.5 months)
Safety Analysis Set includes all participants in the ITT Analysis Set who receive at least one dose of study treatment (pamiparib or placebo).
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
2.8%
2/71 • Number of events 2 • From start of study treatment until 30 days after the last study drug intake or initiation of new anticancer therapy, whichever occurs first (up to approximately 4 years and 5.5 months)
Safety Analysis Set includes all participants in the ITT Analysis Set who receive at least one dose of study treatment (pamiparib or placebo).
|
3.1%
2/65 • Number of events 2 • From start of study treatment until 30 days after the last study drug intake or initiation of new anticancer therapy, whichever occurs first (up to approximately 4 years and 5.5 months)
Safety Analysis Set includes all participants in the ITT Analysis Set who receive at least one dose of study treatment (pamiparib or placebo).
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
0.00%
0/71 • From start of study treatment until 30 days after the last study drug intake or initiation of new anticancer therapy, whichever occurs first (up to approximately 4 years and 5.5 months)
Safety Analysis Set includes all participants in the ITT Analysis Set who receive at least one dose of study treatment (pamiparib or placebo).
|
4.6%
3/65 • Number of events 3 • From start of study treatment until 30 days after the last study drug intake or initiation of new anticancer therapy, whichever occurs first (up to approximately 4 years and 5.5 months)
Safety Analysis Set includes all participants in the ITT Analysis Set who receive at least one dose of study treatment (pamiparib or placebo).
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
4.2%
3/71 • Number of events 3 • From start of study treatment until 30 days after the last study drug intake or initiation of new anticancer therapy, whichever occurs first (up to approximately 4 years and 5.5 months)
Safety Analysis Set includes all participants in the ITT Analysis Set who receive at least one dose of study treatment (pamiparib or placebo).
|
0.00%
0/65 • From start of study treatment until 30 days after the last study drug intake or initiation of new anticancer therapy, whichever occurs first (up to approximately 4 years and 5.5 months)
Safety Analysis Set includes all participants in the ITT Analysis Set who receive at least one dose of study treatment (pamiparib or placebo).
|
|
Skin and subcutaneous tissue disorders
Onycholysis
|
0.00%
0/71 • From start of study treatment until 30 days after the last study drug intake or initiation of new anticancer therapy, whichever occurs first (up to approximately 4 years and 5.5 months)
Safety Analysis Set includes all participants in the ITT Analysis Set who receive at least one dose of study treatment (pamiparib or placebo).
|
3.1%
2/65 • Number of events 2 • From start of study treatment until 30 days after the last study drug intake or initiation of new anticancer therapy, whichever occurs first (up to approximately 4 years and 5.5 months)
Safety Analysis Set includes all participants in the ITT Analysis Set who receive at least one dose of study treatment (pamiparib or placebo).
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/71 • From start of study treatment until 30 days after the last study drug intake or initiation of new anticancer therapy, whichever occurs first (up to approximately 4 years and 5.5 months)
Safety Analysis Set includes all participants in the ITT Analysis Set who receive at least one dose of study treatment (pamiparib or placebo).
|
3.1%
2/65 • Number of events 2 • From start of study treatment until 30 days after the last study drug intake or initiation of new anticancer therapy, whichever occurs first (up to approximately 4 years and 5.5 months)
Safety Analysis Set includes all participants in the ITT Analysis Set who receive at least one dose of study treatment (pamiparib or placebo).
|
|
Vascular disorders
Hypertension
|
2.8%
2/71 • Number of events 3 • From start of study treatment until 30 days after the last study drug intake or initiation of new anticancer therapy, whichever occurs first (up to approximately 4 years and 5.5 months)
Safety Analysis Set includes all participants in the ITT Analysis Set who receive at least one dose of study treatment (pamiparib or placebo).
|
3.1%
2/65 • Number of events 3 • From start of study treatment until 30 days after the last study drug intake or initiation of new anticancer therapy, whichever occurs first (up to approximately 4 years and 5.5 months)
Safety Analysis Set includes all participants in the ITT Analysis Set who receive at least one dose of study treatment (pamiparib or placebo).
|
|
Vascular disorders
Hypotension
|
7.0%
5/71 • Number of events 5 • From start of study treatment until 30 days after the last study drug intake or initiation of new anticancer therapy, whichever occurs first (up to approximately 4 years and 5.5 months)
Safety Analysis Set includes all participants in the ITT Analysis Set who receive at least one dose of study treatment (pamiparib or placebo).
|
0.00%
0/65 • From start of study treatment until 30 days after the last study drug intake or initiation of new anticancer therapy, whichever occurs first (up to approximately 4 years and 5.5 months)
Safety Analysis Set includes all participants in the ITT Analysis Set who receive at least one dose of study treatment (pamiparib or placebo).
|
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