Trial Outcomes & Findings for Study to Evaluate the Safety and Efficacy of TSR-042, Bevacizumab, and Niraparib in Participants With Recurrent Ovarian Cancer (NCT NCT05751629)
NCT ID: NCT05751629
Last Updated: 2023-04-21
Results Overview
ORR was defined as percentage of participants with a confirmed investigator-assessed Best Overall Response (BOR) of confirmed complete response (CR) or partial response (PR), evaluated using Response Evaluation Criteria in Solid Tumors (RECIST) version (v) 1.1. PR is defined as at least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters. CR is defined as the disappearance of all target lesions and any pathological lymph nodes (whether target or non-target) must have reduction in short axis to less than (\<)10 millimeters (mm).
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
41 participants
Primary outcome timeframe
Up to approximately 38 Months
Results posted on
2023-04-21
Participant Flow
This study is a sub study of the master protocol (NCT03574779).
Participant milestones
| Measure |
Cohort A (Dostarlimab + Bevacizumab + Niraparib)
Participants with platinum-resistant advanced, relapsed, high-grade ovarian, fallopian tube, or primary peritoneal cancer, and poly(adenosine diphosphate \[ADP\] ribose) polymerase \[PARP\] inhibitor naive were administered 500 milligrams (mg) of Dostarlimab (TSR-042) via infusion on Day 1 every 3 weeks (Q3W) for 4 cycles (each cycle is of 21 days), followed by 1000 mg every 6 weeks (Q6W) beginning from Day 1 of Cycle 5 until progressive disease (PD) or toxicity. Participants were administered 15 milligram per kilogram (mg/kg) of Bevacizumab via infusion Q3W for up to 15 months. Participants with screening actual body weight greater than or equal (≥) to 77 kg and screening platelet count ≥ 150000 cells per microliter were administered 300 mg of Niraparib orally once daily throughout each 21-day cycle until PD or toxicity. Participants with screening actual body weight less than 77 kg or screening platelet count less than 150000 cells per microliter were administered 200 mg of niraparib orally, once daily throughout each 21-day cycle until PD or toxicity.
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|---|---|
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Overall Study
STARTED
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41
|
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Overall Study
COMPLETED
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0
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Overall Study
NOT COMPLETED
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41
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Reasons for withdrawal
| Measure |
Cohort A (Dostarlimab + Bevacizumab + Niraparib)
Participants with platinum-resistant advanced, relapsed, high-grade ovarian, fallopian tube, or primary peritoneal cancer, and poly(adenosine diphosphate \[ADP\] ribose) polymerase \[PARP\] inhibitor naive were administered 500 milligrams (mg) of Dostarlimab (TSR-042) via infusion on Day 1 every 3 weeks (Q3W) for 4 cycles (each cycle is of 21 days), followed by 1000 mg every 6 weeks (Q6W) beginning from Day 1 of Cycle 5 until progressive disease (PD) or toxicity. Participants were administered 15 milligram per kilogram (mg/kg) of Bevacizumab via infusion Q3W for up to 15 months. Participants with screening actual body weight greater than or equal (≥) to 77 kg and screening platelet count ≥ 150000 cells per microliter were administered 300 mg of Niraparib orally once daily throughout each 21-day cycle until PD or toxicity. Participants with screening actual body weight less than 77 kg or screening platelet count less than 150000 cells per microliter were administered 200 mg of niraparib orally, once daily throughout each 21-day cycle until PD or toxicity.
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|---|---|
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Overall Study
Withdrawal by Subject
|
6
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Overall Study
Death
|
25
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Overall Study
Study Site Closed
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9
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Overall Study
Physician Decision
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1
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Baseline Characteristics
Study to Evaluate the Safety and Efficacy of TSR-042, Bevacizumab, and Niraparib in Participants With Recurrent Ovarian Cancer
Baseline characteristics by cohort
| Measure |
Cohort A (Dostarlimab + Bevacizumab + Niraparib)
n=41 Participants
Participants with platinum-resistant advanced, relapsed, high-grade ovarian, fallopian tube, or primary peritoneal cancer, and poly(adenosine diphosphate \[ADP\] ribose) polymerase \[PARP\] inhibitor naive were administered 500 milligrams (mg) of Dostarlimab (TSR-042) via infusion on Day 1 every 3 weeks (Q3W) for 4 cycles (each cycle is of 21 days), followed by 1000 mg every 6 weeks (Q6W) beginning from Day 1 of Cycle 5 until progressive disease (PD) or toxicity. Participants were administered 15 milligram per kilogram (mg/kg) of Bevacizumab via infusion Q3W for up to 15 months. Participants with screening actual body weight greater than or equal (≥) to 77 kg and screening platelet count ≥ 150000 cells per microliter were administered 300 mg of Niraparib orally once daily throughout each 21-day cycle until PD or toxicity. Participants with screening actual body weight less than 77 kg or screening platelet count less than 150000 cells per microliter were administered 200 mg of niraparib orally, once daily throughout each 21-day cycle until PD or toxicity.
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|---|---|
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Age, Continuous
|
63.8 years
STANDARD_DEVIATION 10.59 • n=39 Participants
|
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Sex: Female, Male
Female
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41 Participants
n=39 Participants
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Sex: Female, Male
Male
|
0 Participants
n=39 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
5 Participants
n=39 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
36 Participants
n=39 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=39 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
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0 Participants
n=39 Participants
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|
Race (NIH/OMB)
Asian
|
1 Participants
n=39 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=39 Participants
|
|
Race (NIH/OMB)
Black or African American
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2 Participants
n=39 Participants
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|
Race (NIH/OMB)
White
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32 Participants
n=39 Participants
|
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Race (NIH/OMB)
More than one race
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0 Participants
n=39 Participants
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Race (NIH/OMB)
Unknown or Not Reported
|
6 Participants
n=39 Participants
|
PRIMARY outcome
Timeframe: Up to approximately 38 MonthsPopulation: Response-evaluable population included all efficacy participants (all participants who received any amount of study treatment with measurable disease at baseline) with at least 1 evaluable post-baseline tumor assessment.
ORR was defined as percentage of participants with a confirmed investigator-assessed Best Overall Response (BOR) of confirmed complete response (CR) or partial response (PR), evaluated using Response Evaluation Criteria in Solid Tumors (RECIST) version (v) 1.1. PR is defined as at least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters. CR is defined as the disappearance of all target lesions and any pathological lymph nodes (whether target or non-target) must have reduction in short axis to less than (\<)10 millimeters (mm).
Outcome measures
| Measure |
Cohort A (Dostarlimab + Bevacizumab + Niraparib)
n=39 Participants
Participants with platinum-resistant advanced, relapsed, high-grade ovarian, fallopian tube, or primary peritoneal cancer, and poly(adenosine diphosphate \[ADP\] ribose) polymerase \[PARP\] inhibitor naive were administered 500 milligrams (mg) of Dostarlimab (TSR-042) via infusion on Day 1 every 3 weeks (Q3W) for 4 cycles (each cycle is of 21 days), followed by 1000 mg every 6 weeks (Q6W) beginning from Day 1 of Cycle 5 until progressive disease (PD) or toxicity. Participants were administered 15 milligram per kilogram (mg/kg) of Bevacizumab via infusion Q3W for up to 15 months. Participants with screening actual body weight greater than or equal (≥) to 77 kg and screening platelet count ≥ 150000 cells per microliter were administered 300 mg of Niraparib orally once daily throughout each 21-day cycle until PD or toxicity. Participants with screening actual body weight less than 77 kg or screening platelet count less than 150000 cells per microliter were administered 200 mg of niraparib orally, once daily throughout each 21-day cycle until PD or toxicity.
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|---|---|
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Confirmed Objective Response Rate (ORR) Per Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 by Investigator Assessment
|
17.9 Percentage of participants
Interval 10.3 to 28.3
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SECONDARY outcome
Timeframe: Up to approximately 38 MonthsPopulation: Efficacy Population included all safety participants (all participants who received any amount of study treatment) with measurable disease at baseline. Measurable disease at baseline was defined by the existence of at least 1 target lesion at baseline tumor assessment.
PFS was defined as the time from the date of the first dose of study treatment to the earliest date of assessment of disease progression or death by any cause in the absence of progression by RECIST v1.1. Disease Progression is defined using RECIST v1.1 as at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm.
Outcome measures
| Measure |
Cohort A (Dostarlimab + Bevacizumab + Niraparib)
n=41 Participants
Participants with platinum-resistant advanced, relapsed, high-grade ovarian, fallopian tube, or primary peritoneal cancer, and poly(adenosine diphosphate \[ADP\] ribose) polymerase \[PARP\] inhibitor naive were administered 500 milligrams (mg) of Dostarlimab (TSR-042) via infusion on Day 1 every 3 weeks (Q3W) for 4 cycles (each cycle is of 21 days), followed by 1000 mg every 6 weeks (Q6W) beginning from Day 1 of Cycle 5 until progressive disease (PD) or toxicity. Participants were administered 15 milligram per kilogram (mg/kg) of Bevacizumab via infusion Q3W for up to 15 months. Participants with screening actual body weight greater than or equal (≥) to 77 kg and screening platelet count ≥ 150000 cells per microliter were administered 300 mg of Niraparib orally once daily throughout each 21-day cycle until PD or toxicity. Participants with screening actual body weight less than 77 kg or screening platelet count less than 150000 cells per microliter were administered 200 mg of niraparib orally, once daily throughout each 21-day cycle until PD or toxicity.
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|---|---|
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Progression Free Survival (PFS) Per RECIST Version 1.1 by Investigator Assessment
|
7.92 Months
Interval 4.17 to 10.87
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SECONDARY outcome
Timeframe: Up to approximately 38 MonthsPopulation: Efficacy Population
OS was defined as the time from the date of the first dose of study treatment to the date of death due to any cause. Median and 95% CI are presented.
Outcome measures
| Measure |
Cohort A (Dostarlimab + Bevacizumab + Niraparib)
n=41 Participants
Participants with platinum-resistant advanced, relapsed, high-grade ovarian, fallopian tube, or primary peritoneal cancer, and poly(adenosine diphosphate \[ADP\] ribose) polymerase \[PARP\] inhibitor naive were administered 500 milligrams (mg) of Dostarlimab (TSR-042) via infusion on Day 1 every 3 weeks (Q3W) for 4 cycles (each cycle is of 21 days), followed by 1000 mg every 6 weeks (Q6W) beginning from Day 1 of Cycle 5 until progressive disease (PD) or toxicity. Participants were administered 15 milligram per kilogram (mg/kg) of Bevacizumab via infusion Q3W for up to 15 months. Participants with screening actual body weight greater than or equal (≥) to 77 kg and screening platelet count ≥ 150000 cells per microliter were administered 300 mg of Niraparib orally once daily throughout each 21-day cycle until PD or toxicity. Participants with screening actual body weight less than 77 kg or screening platelet count less than 150000 cells per microliter were administered 200 mg of niraparib orally, once daily throughout each 21-day cycle until PD or toxicity.
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|---|---|
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Overall Survival (OS)
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22.05 Months
Interval 11.14 to 26.25
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SECONDARY outcome
Timeframe: Up to approximately 38 MonthsPopulation: Response-evaluable population. Only responders by investigator were included in this analysis.
DOR was defined as the time from first documentation of response (CR or PR) until the time of first documentation of disease progression by RECIST version 1.1 based on Investigator's assessment or death by any cause. Partial response is defined as at least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters. Complete response is defined as the disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to less than (\<)10 millimeters (mm).
Outcome measures
| Measure |
Cohort A (Dostarlimab + Bevacizumab + Niraparib)
n=11 Participants
Participants with platinum-resistant advanced, relapsed, high-grade ovarian, fallopian tube, or primary peritoneal cancer, and poly(adenosine diphosphate \[ADP\] ribose) polymerase \[PARP\] inhibitor naive were administered 500 milligrams (mg) of Dostarlimab (TSR-042) via infusion on Day 1 every 3 weeks (Q3W) for 4 cycles (each cycle is of 21 days), followed by 1000 mg every 6 weeks (Q6W) beginning from Day 1 of Cycle 5 until progressive disease (PD) or toxicity. Participants were administered 15 milligram per kilogram (mg/kg) of Bevacizumab via infusion Q3W for up to 15 months. Participants with screening actual body weight greater than or equal (≥) to 77 kg and screening platelet count ≥ 150000 cells per microliter were administered 300 mg of Niraparib orally once daily throughout each 21-day cycle until PD or toxicity. Participants with screening actual body weight less than 77 kg or screening platelet count less than 150000 cells per microliter were administered 200 mg of niraparib orally, once daily throughout each 21-day cycle until PD or toxicity.
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|---|---|
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Duration of Response (DOR) Per RECIST Version 1.1 by Investigator Assessment
|
11.76 Months
Interval 4.86 to 23.98
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SECONDARY outcome
Timeframe: Up to approximately 38 MonthsPopulation: Response-evaluable population.
DCR was defined as the percentage of participants who have achieved best overall response of CR, PR, or stable disease (SD) per RECIST version 1.1 based on Investigator's assessment. Partial response is defined as at least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters. Complete response is defined as the disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to less than (\<)10 millimeters (mm). Stable disease is neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study.
Outcome measures
| Measure |
Cohort A (Dostarlimab + Bevacizumab + Niraparib)
n=39 Participants
Participants with platinum-resistant advanced, relapsed, high-grade ovarian, fallopian tube, or primary peritoneal cancer, and poly(adenosine diphosphate \[ADP\] ribose) polymerase \[PARP\] inhibitor naive were administered 500 milligrams (mg) of Dostarlimab (TSR-042) via infusion on Day 1 every 3 weeks (Q3W) for 4 cycles (each cycle is of 21 days), followed by 1000 mg every 6 weeks (Q6W) beginning from Day 1 of Cycle 5 until progressive disease (PD) or toxicity. Participants were administered 15 milligram per kilogram (mg/kg) of Bevacizumab via infusion Q3W for up to 15 months. Participants with screening actual body weight greater than or equal (≥) to 77 kg and screening platelet count ≥ 150000 cells per microliter were administered 300 mg of Niraparib orally once daily throughout each 21-day cycle until PD or toxicity. Participants with screening actual body weight less than 77 kg or screening platelet count less than 150000 cells per microliter were administered 200 mg of niraparib orally, once daily throughout each 21-day cycle until PD or toxicity.
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|---|---|
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Disease Control Rate (DCR) Per RECIST Version 1.1 by Investigator Assessment
|
76.9 Percentage of participants
Interval 66.0 to 85.6
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SECONDARY outcome
Timeframe: Up to approximately 38 MonthsPopulation: Safety population included all participants who received any amount of study treatment.
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study intervention, whether or not considered related to the study intervention.
Outcome measures
| Measure |
Cohort A (Dostarlimab + Bevacizumab + Niraparib)
n=41 Participants
Participants with platinum-resistant advanced, relapsed, high-grade ovarian, fallopian tube, or primary peritoneal cancer, and poly(adenosine diphosphate \[ADP\] ribose) polymerase \[PARP\] inhibitor naive were administered 500 milligrams (mg) of Dostarlimab (TSR-042) via infusion on Day 1 every 3 weeks (Q3W) for 4 cycles (each cycle is of 21 days), followed by 1000 mg every 6 weeks (Q6W) beginning from Day 1 of Cycle 5 until progressive disease (PD) or toxicity. Participants were administered 15 milligram per kilogram (mg/kg) of Bevacizumab via infusion Q3W for up to 15 months. Participants with screening actual body weight greater than or equal (≥) to 77 kg and screening platelet count ≥ 150000 cells per microliter were administered 300 mg of Niraparib orally once daily throughout each 21-day cycle until PD or toxicity. Participants with screening actual body weight less than 77 kg or screening platelet count less than 150000 cells per microliter were administered 200 mg of niraparib orally, once daily throughout each 21-day cycle until PD or toxicity.
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|---|---|
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Number of Participants With Treatment-emergent Adverse Events (TEAEs)
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41 Participants
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SECONDARY outcome
Timeframe: Up to approximately 38 MonthsPopulation: Safety population.
Blood samples were collected for the analysis of clinical laboratory parameters - chemistry, coagulation, hematology and thyroid.
Outcome measures
| Measure |
Cohort A (Dostarlimab + Bevacizumab + Niraparib)
n=41 Participants
Participants with platinum-resistant advanced, relapsed, high-grade ovarian, fallopian tube, or primary peritoneal cancer, and poly(adenosine diphosphate \[ADP\] ribose) polymerase \[PARP\] inhibitor naive were administered 500 milligrams (mg) of Dostarlimab (TSR-042) via infusion on Day 1 every 3 weeks (Q3W) for 4 cycles (each cycle is of 21 days), followed by 1000 mg every 6 weeks (Q6W) beginning from Day 1 of Cycle 5 until progressive disease (PD) or toxicity. Participants were administered 15 milligram per kilogram (mg/kg) of Bevacizumab via infusion Q3W for up to 15 months. Participants with screening actual body weight greater than or equal (≥) to 77 kg and screening platelet count ≥ 150000 cells per microliter were administered 300 mg of Niraparib orally once daily throughout each 21-day cycle until PD or toxicity. Participants with screening actual body weight less than 77 kg or screening platelet count less than 150000 cells per microliter were administered 200 mg of niraparib orally, once daily throughout each 21-day cycle until PD or toxicity.
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|---|---|
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Number of Participants With Clinically Significant Changes in Clinical Laboratory Parameters - Chemistry, Coagulation, Hematology and Thyroid
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0 Participants
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SECONDARY outcome
Timeframe: Baseline (Day 1) and end of treatment (Up to approximately 32 months)Population: Safety population. Only those participants with data available at the specified data points were analyzed.
Urine samples were collected at indicated time points for the assessment of specific gravity. Baseline is defined as the most recent non-missing measurement prior to or on the first administration of study drug.
Outcome measures
| Measure |
Cohort A (Dostarlimab + Bevacizumab + Niraparib)
n=36 Participants
Participants with platinum-resistant advanced, relapsed, high-grade ovarian, fallopian tube, or primary peritoneal cancer, and poly(adenosine diphosphate \[ADP\] ribose) polymerase \[PARP\] inhibitor naive were administered 500 milligrams (mg) of Dostarlimab (TSR-042) via infusion on Day 1 every 3 weeks (Q3W) for 4 cycles (each cycle is of 21 days), followed by 1000 mg every 6 weeks (Q6W) beginning from Day 1 of Cycle 5 until progressive disease (PD) or toxicity. Participants were administered 15 milligram per kilogram (mg/kg) of Bevacizumab via infusion Q3W for up to 15 months. Participants with screening actual body weight greater than or equal (≥) to 77 kg and screening platelet count ≥ 150000 cells per microliter were administered 300 mg of Niraparib orally once daily throughout each 21-day cycle until PD or toxicity. Participants with screening actual body weight less than 77 kg or screening platelet count less than 150000 cells per microliter were administered 200 mg of niraparib orally, once daily throughout each 21-day cycle until PD or toxicity.
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|---|---|
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Absolute Values in Urinalysis Parameter - Specific Gravity (Ratio)
Baseline
|
1.0149 Ratio
Standard Deviation 0.00794
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Absolute Values in Urinalysis Parameter - Specific Gravity (Ratio)
End of treatment
|
1.0162 Ratio
Standard Deviation 0.00786
|
SECONDARY outcome
Timeframe: Baseline (Day 1) and end of treatment (Up to approximately 32 months)Population: Safety population. Only those participants with data available at the specified data points were analyzed.
Blood samples were collected for the analysis of CA-125. Baseline is defined as the most recent non-missing measurement prior to or on the first administration of study drug.
Outcome measures
| Measure |
Cohort A (Dostarlimab + Bevacizumab + Niraparib)
n=37 Participants
Participants with platinum-resistant advanced, relapsed, high-grade ovarian, fallopian tube, or primary peritoneal cancer, and poly(adenosine diphosphate \[ADP\] ribose) polymerase \[PARP\] inhibitor naive were administered 500 milligrams (mg) of Dostarlimab (TSR-042) via infusion on Day 1 every 3 weeks (Q3W) for 4 cycles (each cycle is of 21 days), followed by 1000 mg every 6 weeks (Q6W) beginning from Day 1 of Cycle 5 until progressive disease (PD) or toxicity. Participants were administered 15 milligram per kilogram (mg/kg) of Bevacizumab via infusion Q3W for up to 15 months. Participants with screening actual body weight greater than or equal (≥) to 77 kg and screening platelet count ≥ 150000 cells per microliter were administered 300 mg of Niraparib orally once daily throughout each 21-day cycle until PD or toxicity. Participants with screening actual body weight less than 77 kg or screening platelet count less than 150000 cells per microliter were administered 200 mg of niraparib orally, once daily throughout each 21-day cycle until PD or toxicity.
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|---|---|
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Change From Baseline in Cancer Antigen 125 (CA-125) at End of Treatment
|
246.86 Units per milliliter (U/mL)
Standard Deviation 608.985
|
SECONDARY outcome
Timeframe: Baseline (Day 1) and end of treatment (Up to approximately 32 months)Population: Safety population. Only those participants with data available at the specified data points were analyzed.
Weight was measured in ordinary indoor clothing (without shoes) and was recorded at specified study visit. Baseline is defined as the most recent non-missing measurement prior to or on the first administration of study drug.
Outcome measures
| Measure |
Cohort A (Dostarlimab + Bevacizumab + Niraparib)
n=36 Participants
Participants with platinum-resistant advanced, relapsed, high-grade ovarian, fallopian tube, or primary peritoneal cancer, and poly(adenosine diphosphate \[ADP\] ribose) polymerase \[PARP\] inhibitor naive were administered 500 milligrams (mg) of Dostarlimab (TSR-042) via infusion on Day 1 every 3 weeks (Q3W) for 4 cycles (each cycle is of 21 days), followed by 1000 mg every 6 weeks (Q6W) beginning from Day 1 of Cycle 5 until progressive disease (PD) or toxicity. Participants were administered 15 milligram per kilogram (mg/kg) of Bevacizumab via infusion Q3W for up to 15 months. Participants with screening actual body weight greater than or equal (≥) to 77 kg and screening platelet count ≥ 150000 cells per microliter were administered 300 mg of Niraparib orally once daily throughout each 21-day cycle until PD or toxicity. Participants with screening actual body weight less than 77 kg or screening platelet count less than 150000 cells per microliter were administered 200 mg of niraparib orally, once daily throughout each 21-day cycle until PD or toxicity.
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|---|---|
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Change From Baseline in Vital Signs (Weight) at End of Treatment
|
-5.07 kilogram
Standard Deviation 5.475
|
SECONDARY outcome
Timeframe: Baseline (Day 1) and end of treatment (Up to approximately 32 months)Population: Safety population. Only those participants with data available at the specified data points were analyzed.
Performance status assessments were based on 5-grade ECOG scale (from 0 to 4), where 0=fully active, able to carry on all pre-disease performance without restriction; 1=restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature (e.g., light house work, office work); 2=ambulatory and capable of all self-care but unable to carry out any work activities, up and about more than 50% of waking hours; 3=capable of only limited self-care, confined to bed or chair more than 50% of waking hours; 4=completely disabled, cannot carry on any self-care, totally confined to bed or chair. Baseline is defined as the most recent non-missing measurement prior to or on the first administration of study drug.
Outcome measures
| Measure |
Cohort A (Dostarlimab + Bevacizumab + Niraparib)
n=40 Participants
Participants with platinum-resistant advanced, relapsed, high-grade ovarian, fallopian tube, or primary peritoneal cancer, and poly(adenosine diphosphate \[ADP\] ribose) polymerase \[PARP\] inhibitor naive were administered 500 milligrams (mg) of Dostarlimab (TSR-042) via infusion on Day 1 every 3 weeks (Q3W) for 4 cycles (each cycle is of 21 days), followed by 1000 mg every 6 weeks (Q6W) beginning from Day 1 of Cycle 5 until progressive disease (PD) or toxicity. Participants were administered 15 milligram per kilogram (mg/kg) of Bevacizumab via infusion Q3W for up to 15 months. Participants with screening actual body weight greater than or equal (≥) to 77 kg and screening platelet count ≥ 150000 cells per microliter were administered 300 mg of Niraparib orally once daily throughout each 21-day cycle until PD or toxicity. Participants with screening actual body weight less than 77 kg or screening platelet count less than 150000 cells per microliter were administered 200 mg of niraparib orally, once daily throughout each 21-day cycle until PD or toxicity.
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|---|---|
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Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status at Baseline and End of Treatment
Baseline · Grade 3
|
0 Participants
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|
Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status at Baseline and End of Treatment
End of Treatment · Grade 0
|
9 Participants
|
|
Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status at Baseline and End of Treatment
Baseline · Grade 0
|
18 Participants
|
|
Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status at Baseline and End of Treatment
Baseline · Grade 1
|
22 Participants
|
|
Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status at Baseline and End of Treatment
Baseline · Grade 2
|
0 Participants
|
|
Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status at Baseline and End of Treatment
Baseline · Grade 4
|
0 Participants
|
|
Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status at Baseline and End of Treatment
End of Treatment · Grade 1
|
20 Participants
|
|
Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status at Baseline and End of Treatment
End of Treatment · Grade 2
|
7 Participants
|
|
Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status at Baseline and End of Treatment
End of Treatment · Grade 3
|
1 Participants
|
|
Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status at Baseline and End of Treatment
End of Treatment · Grade 4
|
0 Participants
|
Adverse Events
Cohort A (Dostarlimab + Bevacizumab + Niraparib)
Serious events: 22 serious events
Other events: 41 other events
Deaths: 25 deaths
Serious adverse events
| Measure |
Cohort A (Dostarlimab + Bevacizumab + Niraparib)
n=41 participants at risk
Participants with platinum-resistant advanced, relapsed, high-grade ovarian, fallopian tube, or primary peritoneal cancer, and poly(adenosine diphosphate \[ADP\] ribose) polymerase \[PARP\] inhibitor naive were administered 500 milligrams (mg) of Dostarlimab (TSR-042) via infusion on Day 1 every 3 weeks (Q3W) for 4 cycles (each cycle is of 21 days), followed by 1000 mg every 6 weeks (Q6W) beginning from Day 1 of Cycle 5 until progressive disease (PD) or toxicity. Participants were administered 15 milligram per kilogram (mg/kg) of Bevacizumab via infusion Q3W for up to 15 months. Participants with screening actual body weight greater than or equal (≥) to 77 kg and screening platelet count ≥ 150000 cells per microliter were administered 300 mg of Niraparib orally once daily throughout each 21-day cycle until PD or toxicity. Participants with screening actual body weight less than 77 kg or screening platelet count less than 150000 cells per microliter were administered 200 mg of niraparib orally, once daily throughout each 21-day cycle until PD or toxicity.
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|---|---|
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Gastrointestinal disorders
Small intestinal obstruction
|
9.8%
4/41 • All-cause mortality, non-serious advents (Non-SAEs) and serious adverse events (SAE) were collected up to 38 months.
Safety population included all participants who received any amount of study treatment.
|
|
Gastrointestinal disorders
Abdominal pain
|
7.3%
3/41 • All-cause mortality, non-serious advents (Non-SAEs) and serious adverse events (SAE) were collected up to 38 months.
Safety population included all participants who received any amount of study treatment.
|
|
Gastrointestinal disorders
Vomiting
|
4.9%
2/41 • All-cause mortality, non-serious advents (Non-SAEs) and serious adverse events (SAE) were collected up to 38 months.
Safety population included all participants who received any amount of study treatment.
|
|
Gastrointestinal disorders
Colitis
|
2.4%
1/41 • All-cause mortality, non-serious advents (Non-SAEs) and serious adverse events (SAE) were collected up to 38 months.
Safety population included all participants who received any amount of study treatment.
|
|
Gastrointestinal disorders
Gastritis
|
2.4%
1/41 • All-cause mortality, non-serious advents (Non-SAEs) and serious adverse events (SAE) were collected up to 38 months.
Safety population included all participants who received any amount of study treatment.
|
|
Gastrointestinal disorders
Ileus
|
2.4%
1/41 • All-cause mortality, non-serious advents (Non-SAEs) and serious adverse events (SAE) were collected up to 38 months.
Safety population included all participants who received any amount of study treatment.
|
|
Gastrointestinal disorders
Intestinal obstruction
|
2.4%
1/41 • All-cause mortality, non-serious advents (Non-SAEs) and serious adverse events (SAE) were collected up to 38 months.
Safety population included all participants who received any amount of study treatment.
|
|
Gastrointestinal disorders
Intestinal perforation
|
2.4%
1/41 • All-cause mortality, non-serious advents (Non-SAEs) and serious adverse events (SAE) were collected up to 38 months.
Safety population included all participants who received any amount of study treatment.
|
|
Gastrointestinal disorders
Nausea
|
2.4%
1/41 • All-cause mortality, non-serious advents (Non-SAEs) and serious adverse events (SAE) were collected up to 38 months.
Safety population included all participants who received any amount of study treatment.
|
|
Gastrointestinal disorders
Small intestinal perforation
|
2.4%
1/41 • All-cause mortality, non-serious advents (Non-SAEs) and serious adverse events (SAE) were collected up to 38 months.
Safety population included all participants who received any amount of study treatment.
|
|
Infections and infestations
COVID-19
|
2.4%
1/41 • All-cause mortality, non-serious advents (Non-SAEs) and serious adverse events (SAE) were collected up to 38 months.
Safety population included all participants who received any amount of study treatment.
|
|
Infections and infestations
Human anaplasmosis
|
2.4%
1/41 • All-cause mortality, non-serious advents (Non-SAEs) and serious adverse events (SAE) were collected up to 38 months.
Safety population included all participants who received any amount of study treatment.
|
|
Infections and infestations
Parainfluenzae virus infection
|
2.4%
1/41 • All-cause mortality, non-serious advents (Non-SAEs) and serious adverse events (SAE) were collected up to 38 months.
Safety population included all participants who received any amount of study treatment.
|
|
Infections and infestations
Sepsis
|
2.4%
1/41 • All-cause mortality, non-serious advents (Non-SAEs) and serious adverse events (SAE) were collected up to 38 months.
Safety population included all participants who received any amount of study treatment.
|
|
Infections and infestations
Skin infection
|
2.4%
1/41 • All-cause mortality, non-serious advents (Non-SAEs) and serious adverse events (SAE) were collected up to 38 months.
Safety population included all participants who received any amount of study treatment.
|
|
Infections and infestations
Viral rash
|
2.4%
1/41 • All-cause mortality, non-serious advents (Non-SAEs) and serious adverse events (SAE) were collected up to 38 months.
Safety population included all participants who received any amount of study treatment.
|
|
Infections and infestations
Vulval abscess
|
2.4%
1/41 • All-cause mortality, non-serious advents (Non-SAEs) and serious adverse events (SAE) were collected up to 38 months.
Safety population included all participants who received any amount of study treatment.
|
|
Blood and lymphatic system disorders
Anaemia
|
4.9%
2/41 • All-cause mortality, non-serious advents (Non-SAEs) and serious adverse events (SAE) were collected up to 38 months.
Safety population included all participants who received any amount of study treatment.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
4.9%
2/41 • All-cause mortality, non-serious advents (Non-SAEs) and serious adverse events (SAE) were collected up to 38 months.
Safety population included all participants who received any amount of study treatment.
|
|
Blood and lymphatic system disorders
Immune-mediated cytopenia
|
2.4%
1/41 • All-cause mortality, non-serious advents (Non-SAEs) and serious adverse events (SAE) were collected up to 38 months.
Safety population included all participants who received any amount of study treatment.
|
|
Hepatobiliary disorders
Cholangitis
|
2.4%
1/41 • All-cause mortality, non-serious advents (Non-SAEs) and serious adverse events (SAE) were collected up to 38 months.
Safety population included all participants who received any amount of study treatment.
|
|
Hepatobiliary disorders
Cholecystitis
|
2.4%
1/41 • All-cause mortality, non-serious advents (Non-SAEs) and serious adverse events (SAE) were collected up to 38 months.
Safety population included all participants who received any amount of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
2.4%
1/41 • All-cause mortality, non-serious advents (Non-SAEs) and serious adverse events (SAE) were collected up to 38 months.
Safety population included all participants who received any amount of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
2.4%
1/41 • All-cause mortality, non-serious advents (Non-SAEs) and serious adverse events (SAE) were collected up to 38 months.
Safety population included all participants who received any amount of study treatment.
|
|
Vascular disorders
Hypertension
|
4.9%
2/41 • All-cause mortality, non-serious advents (Non-SAEs) and serious adverse events (SAE) were collected up to 38 months.
Safety population included all participants who received any amount of study treatment.
|
|
Cardiac disorders
Myocardial infarction
|
2.4%
1/41 • All-cause mortality, non-serious advents (Non-SAEs) and serious adverse events (SAE) were collected up to 38 months.
Safety population included all participants who received any amount of study treatment.
|
|
General disorders
Chest pain
|
2.4%
1/41 • All-cause mortality, non-serious advents (Non-SAEs) and serious adverse events (SAE) were collected up to 38 months.
Safety population included all participants who received any amount of study treatment.
|
|
General disorders
Pyrexia
|
2.4%
1/41 • All-cause mortality, non-serious advents (Non-SAEs) and serious adverse events (SAE) were collected up to 38 months.
Safety population included all participants who received any amount of study treatment.
|
|
Nervous system disorders
Seizure
|
2.4%
1/41 • All-cause mortality, non-serious advents (Non-SAEs) and serious adverse events (SAE) were collected up to 38 months.
Safety population included all participants who received any amount of study treatment.
|
Other adverse events
| Measure |
Cohort A (Dostarlimab + Bevacizumab + Niraparib)
n=41 participants at risk
Participants with platinum-resistant advanced, relapsed, high-grade ovarian, fallopian tube, or primary peritoneal cancer, and poly(adenosine diphosphate \[ADP\] ribose) polymerase \[PARP\] inhibitor naive were administered 500 milligrams (mg) of Dostarlimab (TSR-042) via infusion on Day 1 every 3 weeks (Q3W) for 4 cycles (each cycle is of 21 days), followed by 1000 mg every 6 weeks (Q6W) beginning from Day 1 of Cycle 5 until progressive disease (PD) or toxicity. Participants were administered 15 milligram per kilogram (mg/kg) of Bevacizumab via infusion Q3W for up to 15 months. Participants with screening actual body weight greater than or equal (≥) to 77 kg and screening platelet count ≥ 150000 cells per microliter were administered 300 mg of Niraparib orally once daily throughout each 21-day cycle until PD or toxicity. Participants with screening actual body weight less than 77 kg or screening platelet count less than 150000 cells per microliter were administered 200 mg of niraparib orally, once daily throughout each 21-day cycle until PD or toxicity.
|
|---|---|
|
Investigations
Lymphocyte count decreased
|
7.3%
3/41 • Number of events 5 • All-cause mortality, non-serious advents (Non-SAEs) and serious adverse events (SAE) were collected up to 38 months.
Safety population included all participants who received any amount of study treatment.
|
|
Gastrointestinal disorders
Nausea
|
68.3%
28/41 • Number of events 47 • All-cause mortality, non-serious advents (Non-SAEs) and serious adverse events (SAE) were collected up to 38 months.
Safety population included all participants who received any amount of study treatment.
|
|
Gastrointestinal disorders
Vomiting
|
56.1%
23/41 • Number of events 47 • All-cause mortality, non-serious advents (Non-SAEs) and serious adverse events (SAE) were collected up to 38 months.
Safety population included all participants who received any amount of study treatment.
|
|
Gastrointestinal disorders
Abdominal pain
|
39.0%
16/41 • Number of events 22 • All-cause mortality, non-serious advents (Non-SAEs) and serious adverse events (SAE) were collected up to 38 months.
Safety population included all participants who received any amount of study treatment.
|
|
Gastrointestinal disorders
Constipation
|
36.6%
15/41 • Number of events 27 • All-cause mortality, non-serious advents (Non-SAEs) and serious adverse events (SAE) were collected up to 38 months.
Safety population included all participants who received any amount of study treatment.
|
|
Gastrointestinal disorders
Diarrhoea
|
34.1%
14/41 • Number of events 19 • All-cause mortality, non-serious advents (Non-SAEs) and serious adverse events (SAE) were collected up to 38 months.
Safety population included all participants who received any amount of study treatment.
|
|
Gastrointestinal disorders
Abdominal distension
|
19.5%
8/41 • Number of events 9 • All-cause mortality, non-serious advents (Non-SAEs) and serious adverse events (SAE) were collected up to 38 months.
Safety population included all participants who received any amount of study treatment.
|
|
Gastrointestinal disorders
Stomatitis
|
12.2%
5/41 • Number of events 10 • All-cause mortality, non-serious advents (Non-SAEs) and serious adverse events (SAE) were collected up to 38 months.
Safety population included all participants who received any amount of study treatment.
|
|
Gastrointestinal disorders
Abdominal discomfort
|
9.8%
4/41 • Number of events 5 • All-cause mortality, non-serious advents (Non-SAEs) and serious adverse events (SAE) were collected up to 38 months.
Safety population included all participants who received any amount of study treatment.
|
|
Gastrointestinal disorders
Ascites
|
9.8%
4/41 • Number of events 6 • All-cause mortality, non-serious advents (Non-SAEs) and serious adverse events (SAE) were collected up to 38 months.
Safety population included all participants who received any amount of study treatment.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
7.3%
3/41 • Number of events 4 • All-cause mortality, non-serious advents (Non-SAEs) and serious adverse events (SAE) were collected up to 38 months.
Safety population included all participants who received any amount of study treatment.
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
7.3%
3/41 • Number of events 4 • All-cause mortality, non-serious advents (Non-SAEs) and serious adverse events (SAE) were collected up to 38 months.
Safety population included all participants who received any amount of study treatment.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
4.9%
2/41 • Number of events 4 • All-cause mortality, non-serious advents (Non-SAEs) and serious adverse events (SAE) were collected up to 38 months.
Safety population included all participants who received any amount of study treatment.
|
|
Gastrointestinal disorders
Dyspepsia
|
4.9%
2/41 • Number of events 2 • All-cause mortality, non-serious advents (Non-SAEs) and serious adverse events (SAE) were collected up to 38 months.
Safety population included all participants who received any amount of study treatment.
|
|
Gastrointestinal disorders
Haematochezia
|
4.9%
2/41 • Number of events 3 • All-cause mortality, non-serious advents (Non-SAEs) and serious adverse events (SAE) were collected up to 38 months.
Safety population included all participants who received any amount of study treatment.
|
|
Gastrointestinal disorders
Haemorrhoids
|
4.9%
2/41 • Number of events 2 • All-cause mortality, non-serious advents (Non-SAEs) and serious adverse events (SAE) were collected up to 38 months.
Safety population included all participants who received any amount of study treatment.
|
|
Gastrointestinal disorders
Toothache
|
4.9%
2/41 • Number of events 2 • All-cause mortality, non-serious advents (Non-SAEs) and serious adverse events (SAE) were collected up to 38 months.
Safety population included all participants who received any amount of study treatment.
|
|
Gastrointestinal disorders
Anal incontinence
|
2.4%
1/41 • Number of events 1 • All-cause mortality, non-serious advents (Non-SAEs) and serious adverse events (SAE) were collected up to 38 months.
Safety population included all participants who received any amount of study treatment.
|
|
Gastrointestinal disorders
Colitis
|
2.4%
1/41 • Number of events 2 • All-cause mortality, non-serious advents (Non-SAEs) and serious adverse events (SAE) were collected up to 38 months.
Safety population included all participants who received any amount of study treatment.
|
|
Gastrointestinal disorders
Dental caries
|
2.4%
1/41 • Number of events 1 • All-cause mortality, non-serious advents (Non-SAEs) and serious adverse events (SAE) were collected up to 38 months.
Safety population included all participants who received any amount of study treatment.
|
|
Gastrointestinal disorders
Dry mouth
|
2.4%
1/41 • Number of events 1 • All-cause mortality, non-serious advents (Non-SAEs) and serious adverse events (SAE) were collected up to 38 months.
Safety population included all participants who received any amount of study treatment.
|
|
Gastrointestinal disorders
Duodenitis
|
2.4%
1/41 • Number of events 1 • All-cause mortality, non-serious advents (Non-SAEs) and serious adverse events (SAE) were collected up to 38 months.
Safety population included all participants who received any amount of study treatment.
|
|
Gastrointestinal disorders
Dysphagia
|
2.4%
1/41 • Number of events 1 • All-cause mortality, non-serious advents (Non-SAEs) and serious adverse events (SAE) were collected up to 38 months.
Safety population included all participants who received any amount of study treatment.
|
|
Gastrointestinal disorders
Flatulence
|
2.4%
1/41 • Number of events 2 • All-cause mortality, non-serious advents (Non-SAEs) and serious adverse events (SAE) were collected up to 38 months.
Safety population included all participants who received any amount of study treatment.
|
|
Gastrointestinal disorders
Gingival bleeding
|
2.4%
1/41 • Number of events 2 • All-cause mortality, non-serious advents (Non-SAEs) and serious adverse events (SAE) were collected up to 38 months.
Safety population included all participants who received any amount of study treatment.
|
|
Gastrointestinal disorders
Gingival ulceration
|
2.4%
1/41 • Number of events 2 • All-cause mortality, non-serious advents (Non-SAEs) and serious adverse events (SAE) were collected up to 38 months.
Safety population included all participants who received any amount of study treatment.
|
|
Gastrointestinal disorders
Oral disorder
|
2.4%
1/41 • Number of events 1 • All-cause mortality, non-serious advents (Non-SAEs) and serious adverse events (SAE) were collected up to 38 months.
Safety population included all participants who received any amount of study treatment.
|
|
Gastrointestinal disorders
Oral dysaesthesia
|
2.4%
1/41 • Number of events 3 • All-cause mortality, non-serious advents (Non-SAEs) and serious adverse events (SAE) were collected up to 38 months.
Safety population included all participants who received any amount of study treatment.
|
|
Gastrointestinal disorders
Oral pruritus
|
2.4%
1/41 • Number of events 1 • All-cause mortality, non-serious advents (Non-SAEs) and serious adverse events (SAE) were collected up to 38 months.
Safety population included all participants who received any amount of study treatment.
|
|
Gastrointestinal disorders
Proctalgia
|
2.4%
1/41 • Number of events 1 • All-cause mortality, non-serious advents (Non-SAEs) and serious adverse events (SAE) were collected up to 38 months.
Safety population included all participants who received any amount of study treatment.
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
2.4%
1/41 • Number of events 1 • All-cause mortality, non-serious advents (Non-SAEs) and serious adverse events (SAE) were collected up to 38 months.
Safety population included all participants who received any amount of study treatment.
|
|
Gastrointestinal disorders
Retching
|
2.4%
1/41 • Number of events 1 • All-cause mortality, non-serious advents (Non-SAEs) and serious adverse events (SAE) were collected up to 38 months.
Safety population included all participants who received any amount of study treatment.
|
|
Gastrointestinal disorders
Short-bowel syndrome
|
2.4%
1/41 • Number of events 1 • All-cause mortality, non-serious advents (Non-SAEs) and serious adverse events (SAE) were collected up to 38 months.
Safety population included all participants who received any amount of study treatment.
|
|
Investigations
Platelet count decreased
|
41.5%
17/41 • Number of events 51 • All-cause mortality, non-serious advents (Non-SAEs) and serious adverse events (SAE) were collected up to 38 months.
Safety population included all participants who received any amount of study treatment.
|
|
Investigations
Aspartate aminotransferase increased
|
36.6%
15/41 • Number of events 24 • All-cause mortality, non-serious advents (Non-SAEs) and serious adverse events (SAE) were collected up to 38 months.
Safety population included all participants who received any amount of study treatment.
|
|
Investigations
Blood creatinine increased
|
26.8%
11/41 • Number of events 17 • All-cause mortality, non-serious advents (Non-SAEs) and serious adverse events (SAE) were collected up to 38 months.
Safety population included all participants who received any amount of study treatment.
|
|
Investigations
Neutrophil count decreased
|
26.8%
11/41 • Number of events 29 • All-cause mortality, non-serious advents (Non-SAEs) and serious adverse events (SAE) were collected up to 38 months.
Safety population included all participants who received any amount of study treatment.
|
|
Investigations
Alanine aminotransferase increased
|
24.4%
10/41 • Number of events 27 • All-cause mortality, non-serious advents (Non-SAEs) and serious adverse events (SAE) were collected up to 38 months.
Safety population included all participants who received any amount of study treatment.
|
|
Investigations
Blood alkaline phosphatase increased
|
22.0%
9/41 • Number of events 17 • All-cause mortality, non-serious advents (Non-SAEs) and serious adverse events (SAE) were collected up to 38 months.
Safety population included all participants who received any amount of study treatment.
|
|
Investigations
Weight decreased
|
17.1%
7/41 • Number of events 9 • All-cause mortality, non-serious advents (Non-SAEs) and serious adverse events (SAE) were collected up to 38 months.
Safety population included all participants who received any amount of study treatment.
|
|
Investigations
Amylase increased
|
9.8%
4/41 • Number of events 4 • All-cause mortality, non-serious advents (Non-SAEs) and serious adverse events (SAE) were collected up to 38 months.
Safety population included all participants who received any amount of study treatment.
|
|
Investigations
Blood chloride decreased
|
9.8%
4/41 • Number of events 4 • All-cause mortality, non-serious advents (Non-SAEs) and serious adverse events (SAE) were collected up to 38 months.
Safety population included all participants who received any amount of study treatment.
|
|
Investigations
Blood lactate dehydrogenase increased
|
9.8%
4/41 • Number of events 5 • All-cause mortality, non-serious advents (Non-SAEs) and serious adverse events (SAE) were collected up to 38 months.
Safety population included all participants who received any amount of study treatment.
|
|
Investigations
White blood cell count decreased
|
9.8%
4/41 • Number of events 21 • All-cause mortality, non-serious advents (Non-SAEs) and serious adverse events (SAE) were collected up to 38 months.
Safety population included all participants who received any amount of study treatment.
|
|
Investigations
Blood thyroid stimulating hormone increased
|
7.3%
3/41 • Number of events 6 • All-cause mortality, non-serious advents (Non-SAEs) and serious adverse events (SAE) were collected up to 38 months.
Safety population included all participants who received any amount of study treatment.
|
|
Investigations
Activated partial thromboplastin time prolonged
|
4.9%
2/41 • Number of events 2 • All-cause mortality, non-serious advents (Non-SAEs) and serious adverse events (SAE) were collected up to 38 months.
Safety population included all participants who received any amount of study treatment.
|
|
Investigations
International normalised ratio increased
|
4.9%
2/41 • Number of events 4 • All-cause mortality, non-serious advents (Non-SAEs) and serious adverse events (SAE) were collected up to 38 months.
Safety population included all participants who received any amount of study treatment.
|
|
Investigations
Blood albumin increased
|
2.4%
1/41 • Number of events 1 • All-cause mortality, non-serious advents (Non-SAEs) and serious adverse events (SAE) were collected up to 38 months.
Safety population included all participants who received any amount of study treatment.
|
|
Investigations
Blood glucose increased
|
2.4%
1/41 • Number of events 1 • All-cause mortality, non-serious advents (Non-SAEs) and serious adverse events (SAE) were collected up to 38 months.
Safety population included all participants who received any amount of study treatment.
|
|
Investigations
Blood urea increased
|
2.4%
1/41 • Number of events 2 • All-cause mortality, non-serious advents (Non-SAEs) and serious adverse events (SAE) were collected up to 38 months.
Safety population included all participants who received any amount of study treatment.
|
|
Investigations
Carbohydrate antigen 125 increased
|
2.4%
1/41 • Number of events 1 • All-cause mortality, non-serious advents (Non-SAEs) and serious adverse events (SAE) were collected up to 38 months.
Safety population included all participants who received any amount of study treatment.
|
|
Investigations
Neutrophil count increased
|
2.4%
1/41 • Number of events 1 • All-cause mortality, non-serious advents (Non-SAEs) and serious adverse events (SAE) were collected up to 38 months.
Safety population included all participants who received any amount of study treatment.
|
|
Investigations
Protein total decreased
|
2.4%
1/41 • Number of events 1 • All-cause mortality, non-serious advents (Non-SAEs) and serious adverse events (SAE) were collected up to 38 months.
Safety population included all participants who received any amount of study treatment.
|
|
Investigations
Protein total increased
|
2.4%
1/41 • Number of events 2 • All-cause mortality, non-serious advents (Non-SAEs) and serious adverse events (SAE) were collected up to 38 months.
Safety population included all participants who received any amount of study treatment.
|
|
Investigations
Prothrombin time prolonged
|
2.4%
1/41 • Number of events 1 • All-cause mortality, non-serious advents (Non-SAEs) and serious adverse events (SAE) were collected up to 38 months.
Safety population included all participants who received any amount of study treatment.
|
|
Investigations
Thyroxine free increased
|
2.4%
1/41 • Number of events 1 • All-cause mortality, non-serious advents (Non-SAEs) and serious adverse events (SAE) were collected up to 38 months.
Safety population included all participants who received any amount of study treatment.
|
|
Investigations
Troponin increased
|
2.4%
1/41 • Number of events 2 • All-cause mortality, non-serious advents (Non-SAEs) and serious adverse events (SAE) were collected up to 38 months.
Safety population included all participants who received any amount of study treatment.
|
|
Investigations
Urine protein/creatinine ration increased
|
2.4%
1/41 • Number of events 2 • All-cause mortality, non-serious advents (Non-SAEs) and serious adverse events (SAE) were collected up to 38 months.
Safety population included all participants who received any amount of study treatment.
|
|
General disorders
Fatigue
|
73.2%
30/41 • Number of events 59 • All-cause mortality, non-serious advents (Non-SAEs) and serious adverse events (SAE) were collected up to 38 months.
Safety population included all participants who received any amount of study treatment.
|
|
General disorders
Pyrexia
|
19.5%
8/41 • Number of events 18 • All-cause mortality, non-serious advents (Non-SAEs) and serious adverse events (SAE) were collected up to 38 months.
Safety population included all participants who received any amount of study treatment.
|
|
General disorders
Oedema peripheral
|
17.1%
7/41 • Number of events 8 • All-cause mortality, non-serious advents (Non-SAEs) and serious adverse events (SAE) were collected up to 38 months.
Safety population included all participants who received any amount of study treatment.
|
|
General disorders
Mucosal inflamation
|
9.8%
4/41 • Number of events 4 • All-cause mortality, non-serious advents (Non-SAEs) and serious adverse events (SAE) were collected up to 38 months.
Safety population included all participants who received any amount of study treatment.
|
|
General disorders
Chest pain
|
7.3%
3/41 • Number of events 4 • All-cause mortality, non-serious advents (Non-SAEs) and serious adverse events (SAE) were collected up to 38 months.
Safety population included all participants who received any amount of study treatment.
|
|
General disorders
Malaise
|
7.3%
3/41 • Number of events 3 • All-cause mortality, non-serious advents (Non-SAEs) and serious adverse events (SAE) were collected up to 38 months.
Safety population included all participants who received any amount of study treatment.
|
|
General disorders
Asthenia
|
2.4%
1/41 • Number of events 1 • All-cause mortality, non-serious advents (Non-SAEs) and serious adverse events (SAE) were collected up to 38 months.
Safety population included all participants who received any amount of study treatment.
|
|
General disorders
Catheter site pruritus
|
2.4%
1/41 • Number of events 1 • All-cause mortality, non-serious advents (Non-SAEs) and serious adverse events (SAE) were collected up to 38 months.
Safety population included all participants who received any amount of study treatment.
|
|
General disorders
Chills
|
2.4%
1/41 • Number of events 1 • All-cause mortality, non-serious advents (Non-SAEs) and serious adverse events (SAE) were collected up to 38 months.
Safety population included all participants who received any amount of study treatment.
|
|
General disorders
Gait disturbance
|
2.4%
1/41 • Number of events 1 • All-cause mortality, non-serious advents (Non-SAEs) and serious adverse events (SAE) were collected up to 38 months.
Safety population included all participants who received any amount of study treatment.
|
|
General disorders
Oedema
|
2.4%
1/41 • Number of events 1 • All-cause mortality, non-serious advents (Non-SAEs) and serious adverse events (SAE) were collected up to 38 months.
Safety population included all participants who received any amount of study treatment.
|
|
General disorders
Peripheral swelling
|
2.4%
1/41 • Number of events 1 • All-cause mortality, non-serious advents (Non-SAEs) and serious adverse events (SAE) were collected up to 38 months.
Safety population included all participants who received any amount of study treatment.
|
|
General disorders
Ulcer
|
2.4%
1/41 • Number of events 1 • All-cause mortality, non-serious advents (Non-SAEs) and serious adverse events (SAE) were collected up to 38 months.
Safety population included all participants who received any amount of study treatment.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
36.6%
15/41 • Number of events 24 • All-cause mortality, non-serious advents (Non-SAEs) and serious adverse events (SAE) were collected up to 38 months.
Safety population included all participants who received any amount of study treatment.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
34.1%
14/41 • Number of events 22 • All-cause mortality, non-serious advents (Non-SAEs) and serious adverse events (SAE) were collected up to 38 months.
Safety population included all participants who received any amount of study treatment.
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
19.5%
8/41 • Number of events 11 • All-cause mortality, non-serious advents (Non-SAEs) and serious adverse events (SAE) were collected up to 38 months.
Safety population included all participants who received any amount of study treatment.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
12.2%
5/41 • Number of events 6 • All-cause mortality, non-serious advents (Non-SAEs) and serious adverse events (SAE) were collected up to 38 months.
Safety population included all participants who received any amount of study treatment.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
12.2%
5/41 • Number of events 8 • All-cause mortality, non-serious advents (Non-SAEs) and serious adverse events (SAE) were collected up to 38 months.
Safety population included all participants who received any amount of study treatment.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
9.8%
4/41 • Number of events 12 • All-cause mortality, non-serious advents (Non-SAEs) and serious adverse events (SAE) were collected up to 38 months.
Safety population included all participants who received any amount of study treatment.
|
|
Metabolism and nutrition disorders
Hypernatraemia
|
7.3%
3/41 • Number of events 3 • All-cause mortality, non-serious advents (Non-SAEs) and serious adverse events (SAE) were collected up to 38 months.
Safety population included all participants who received any amount of study treatment.
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
7.3%
3/41 • Number of events 4 • All-cause mortality, non-serious advents (Non-SAEs) and serious adverse events (SAE) were collected up to 38 months.
Safety population included all participants who received any amount of study treatment.
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
4.9%
2/41 • Number of events 2 • All-cause mortality, non-serious advents (Non-SAEs) and serious adverse events (SAE) were collected up to 38 months.
Safety population included all participants who received any amount of study treatment.
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
2.4%
1/41 • Number of events 1 • All-cause mortality, non-serious advents (Non-SAEs) and serious adverse events (SAE) were collected up to 38 months.
Safety population included all participants who received any amount of study treatment.
|
|
Metabolism and nutrition disorders
Hypermagnesaemia
|
2.4%
1/41 • Number of events 1 • All-cause mortality, non-serious advents (Non-SAEs) and serious adverse events (SAE) were collected up to 38 months.
Safety population included all participants who received any amount of study treatment.
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
2.4%
1/41 • Number of events 1 • All-cause mortality, non-serious advents (Non-SAEs) and serious adverse events (SAE) were collected up to 38 months.
Safety population included all participants who received any amount of study treatment.
|
|
Metabolism and nutrition disorders
Iron deficiency
|
2.4%
1/41 • Number of events 1 • All-cause mortality, non-serious advents (Non-SAEs) and serious adverse events (SAE) were collected up to 38 months.
Safety population included all participants who received any amount of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
31.7%
13/41 • Number of events 22 • All-cause mortality, non-serious advents (Non-SAEs) and serious adverse events (SAE) were collected up to 38 months.
Safety population included all participants who received any amount of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
24.4%
10/41 • Number of events 16 • All-cause mortality, non-serious advents (Non-SAEs) and serious adverse events (SAE) were collected up to 38 months.
Safety population included all participants who received any amount of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
19.5%
8/41 • Number of events 11 • All-cause mortality, non-serious advents (Non-SAEs) and serious adverse events (SAE) were collected up to 38 months.
Safety population included all participants who received any amount of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
17.1%
7/41 • Number of events 12 • All-cause mortality, non-serious advents (Non-SAEs) and serious adverse events (SAE) were collected up to 38 months.
Safety population included all participants who received any amount of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
9.8%
4/41 • Number of events 4 • All-cause mortality, non-serious advents (Non-SAEs) and serious adverse events (SAE) were collected up to 38 months.
Safety population included all participants who received any amount of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
9.8%
4/41 • Number of events 9 • All-cause mortality, non-serious advents (Non-SAEs) and serious adverse events (SAE) were collected up to 38 months.
Safety population included all participants who received any amount of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
4.9%
2/41 • Number of events 2 • All-cause mortality, non-serious advents (Non-SAEs) and serious adverse events (SAE) were collected up to 38 months.
Safety population included all participants who received any amount of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
4.9%
2/41 • Number of events 5 • All-cause mortality, non-serious advents (Non-SAEs) and serious adverse events (SAE) were collected up to 38 months.
Safety population included all participants who received any amount of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
4.9%
2/41 • Number of events 2 • All-cause mortality, non-serious advents (Non-SAEs) and serious adverse events (SAE) were collected up to 38 months.
Safety population included all participants who received any amount of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Dry throat
|
2.4%
1/41 • Number of events 1 • All-cause mortality, non-serious advents (Non-SAEs) and serious adverse events (SAE) were collected up to 38 months.
Safety population included all participants who received any amount of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
2.4%
1/41 • Number of events 1 • All-cause mortality, non-serious advents (Non-SAEs) and serious adverse events (SAE) were collected up to 38 months.
Safety population included all participants who received any amount of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
2.4%
1/41 • Number of events 1 • All-cause mortality, non-serious advents (Non-SAEs) and serious adverse events (SAE) were collected up to 38 months.
Safety population included all participants who received any amount of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal dryness
|
2.4%
1/41 • Number of events 2 • All-cause mortality, non-serious advents (Non-SAEs) and serious adverse events (SAE) were collected up to 38 months.
Safety population included all participants who received any amount of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
2.4%
1/41 • Number of events 1 • All-cause mortality, non-serious advents (Non-SAEs) and serious adverse events (SAE) were collected up to 38 months.
Safety population included all participants who received any amount of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis allergic
|
2.4%
1/41 • Number of events 1 • All-cause mortality, non-serious advents (Non-SAEs) and serious adverse events (SAE) were collected up to 38 months.
Safety population included all participants who received any amount of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Tachypnoea
|
2.4%
1/41 • Number of events 1 • All-cause mortality, non-serious advents (Non-SAEs) and serious adverse events (SAE) were collected up to 38 months.
Safety population included all participants who received any amount of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Upper-airway cough syndrome
|
2.4%
1/41 • Number of events 2 • All-cause mortality, non-serious advents (Non-SAEs) and serious adverse events (SAE) were collected up to 38 months.
Safety population included all participants who received any amount of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
2.4%
1/41 • Number of events 1 • All-cause mortality, non-serious advents (Non-SAEs) and serious adverse events (SAE) were collected up to 38 months.
Safety population included all participants who received any amount of study treatment.
|
|
Blood and lymphatic system disorders
Anaemia
|
46.3%
19/41 • Number of events 69 • All-cause mortality, non-serious advents (Non-SAEs) and serious adverse events (SAE) were collected up to 38 months.
Safety population included all participants who received any amount of study treatment.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
19.5%
8/41 • Number of events 16 • All-cause mortality, non-serious advents (Non-SAEs) and serious adverse events (SAE) were collected up to 38 months.
Safety population included all participants who received any amount of study treatment.
|
|
Blood and lymphatic system disorders
Lymphopenia
|
12.2%
5/41 • Number of events 23 • All-cause mortality, non-serious advents (Non-SAEs) and serious adverse events (SAE) were collected up to 38 months.
Safety population included all participants who received any amount of study treatment.
|
|
Blood and lymphatic system disorders
Neutropenia
|
9.8%
4/41 • Number of events 4 • All-cause mortality, non-serious advents (Non-SAEs) and serious adverse events (SAE) were collected up to 38 months.
Safety population included all participants who received any amount of study treatment.
|
|
Blood and lymphatic system disorders
Leukocytosis
|
2.4%
1/41 • Number of events 1 • All-cause mortality, non-serious advents (Non-SAEs) and serious adverse events (SAE) were collected up to 38 months.
Safety population included all participants who received any amount of study treatment.
|
|
Blood and lymphatic system disorders
Normocytic anaemia
|
2.4%
1/41 • Number of events 1 • All-cause mortality, non-serious advents (Non-SAEs) and serious adverse events (SAE) were collected up to 38 months.
Safety population included all participants who received any amount of study treatment.
|
|
Blood and lymphatic system disorders
Thrombocytosis
|
2.4%
1/41 • Number of events 4 • All-cause mortality, non-serious advents (Non-SAEs) and serious adverse events (SAE) were collected up to 38 months.
Safety population included all participants who received any amount of study treatment.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
29.3%
12/41 • Number of events 19 • All-cause mortality, non-serious advents (Non-SAEs) and serious adverse events (SAE) were collected up to 38 months.
Safety population included all participants who received any amount of study treatment.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
24.4%
10/41 • Number of events 10 • All-cause mortality, non-serious advents (Non-SAEs) and serious adverse events (SAE) were collected up to 38 months.
Safety population included all participants who received any amount of study treatment.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
24.4%
10/41 • Number of events 10 • All-cause mortality, non-serious advents (Non-SAEs) and serious adverse events (SAE) were collected up to 38 months.
Safety population included all participants who received any amount of study treatment.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
9.8%
4/41 • Number of events 4 • All-cause mortality, non-serious advents (Non-SAEs) and serious adverse events (SAE) were collected up to 38 months.
Safety population included all participants who received any amount of study treatment.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
7.3%
3/41 • Number of events 5 • All-cause mortality, non-serious advents (Non-SAEs) and serious adverse events (SAE) were collected up to 38 months.
Safety population included all participants who received any amount of study treatment.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
7.3%
3/41 • Number of events 3 • All-cause mortality, non-serious advents (Non-SAEs) and serious adverse events (SAE) were collected up to 38 months.
Safety population included all participants who received any amount of study treatment.
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
2.4%
1/41 • Number of events 1 • All-cause mortality, non-serious advents (Non-SAEs) and serious adverse events (SAE) were collected up to 38 months.
Safety population included all participants who received any amount of study treatment.
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
2.4%
1/41 • Number of events 1 • All-cause mortality, non-serious advents (Non-SAEs) and serious adverse events (SAE) were collected up to 38 months.
Safety population included all participants who received any amount of study treatment.
|
|
Musculoskeletal and connective tissue disorders
Groin pain
|
2.4%
1/41 • Number of events 1 • All-cause mortality, non-serious advents (Non-SAEs) and serious adverse events (SAE) were collected up to 38 months.
Safety population included all participants who received any amount of study treatment.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal discomfort
|
2.4%
1/41 • Number of events 1 • All-cause mortality, non-serious advents (Non-SAEs) and serious adverse events (SAE) were collected up to 38 months.
Safety population included all participants who received any amount of study treatment.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
2.4%
1/41 • Number of events 1 • All-cause mortality, non-serious advents (Non-SAEs) and serious adverse events (SAE) were collected up to 38 months.
Safety population included all participants who received any amount of study treatment.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
2.4%
1/41 • Number of events 1 • All-cause mortality, non-serious advents (Non-SAEs) and serious adverse events (SAE) were collected up to 38 months.
Safety population included all participants who received any amount of study treatment.
|
|
Musculoskeletal and connective tissue disorders
Osteopenia
|
2.4%
1/41 • Number of events 1 • All-cause mortality, non-serious advents (Non-SAEs) and serious adverse events (SAE) were collected up to 38 months.
Safety population included all participants who received any amount of study treatment.
|
|
Musculoskeletal and connective tissue disorders
Pain in jaw
|
2.4%
1/41 • Number of events 1 • All-cause mortality, non-serious advents (Non-SAEs) and serious adverse events (SAE) were collected up to 38 months.
Safety population included all participants who received any amount of study treatment.
|
|
Musculoskeletal and connective tissue disorders
Systemic lupus erythematosus
|
2.4%
1/41 • Number of events 1 • All-cause mortality, non-serious advents (Non-SAEs) and serious adverse events (SAE) were collected up to 38 months.
Safety population included all participants who received any amount of study treatment.
|
|
Musculoskeletal and connective tissue disorders
Tendonitis
|
2.4%
1/41 • Number of events 1 • All-cause mortality, non-serious advents (Non-SAEs) and serious adverse events (SAE) were collected up to 38 months.
Safety population included all participants who received any amount of study treatment.
|
|
Skin and subcutaneous tissue disorders
Rash
|
24.4%
10/41 • Number of events 19 • All-cause mortality, non-serious advents (Non-SAEs) and serious adverse events (SAE) were collected up to 38 months.
Safety population included all participants who received any amount of study treatment.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
19.5%
8/41 • Number of events 10 • All-cause mortality, non-serious advents (Non-SAEs) and serious adverse events (SAE) were collected up to 38 months.
Safety population included all participants who received any amount of study treatment.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
12.2%
5/41 • Number of events 6 • All-cause mortality, non-serious advents (Non-SAEs) and serious adverse events (SAE) were collected up to 38 months.
Safety population included all participants who received any amount of study treatment.
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
4.9%
2/41 • Number of events 2 • All-cause mortality, non-serious advents (Non-SAEs) and serious adverse events (SAE) were collected up to 38 months.
Safety population included all participants who received any amount of study treatment.
|
|
Skin and subcutaneous tissue disorders
Petechiae
|
4.9%
2/41 • Number of events 4 • All-cause mortality, non-serious advents (Non-SAEs) and serious adverse events (SAE) were collected up to 38 months.
Safety population included all participants who received any amount of study treatment.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
2.4%
1/41 • Number of events 1 • All-cause mortality, non-serious advents (Non-SAEs) and serious adverse events (SAE) were collected up to 38 months.
Safety population included all participants who received any amount of study treatment.
|
|
Skin and subcutaneous tissue disorders
Dermatitis acneiform
|
2.4%
1/41 • Number of events 1 • All-cause mortality, non-serious advents (Non-SAEs) and serious adverse events (SAE) were collected up to 38 months.
Safety population included all participants who received any amount of study treatment.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
2.4%
1/41 • Number of events 1 • All-cause mortality, non-serious advents (Non-SAEs) and serious adverse events (SAE) were collected up to 38 months.
Safety population included all participants who received any amount of study treatment.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
2.4%
1/41 • Number of events 1 • All-cause mortality, non-serious advents (Non-SAEs) and serious adverse events (SAE) were collected up to 38 months.
Safety population included all participants who received any amount of study treatment.
|
|
Skin and subcutaneous tissue disorders
Night sweats
|
2.4%
1/41 • Number of events 1 • All-cause mortality, non-serious advents (Non-SAEs) and serious adverse events (SAE) were collected up to 38 months.
Safety population included all participants who received any amount of study treatment.
|
|
Vascular disorders
Hypertension
|
48.8%
20/41 • Number of events 41 • All-cause mortality, non-serious advents (Non-SAEs) and serious adverse events (SAE) were collected up to 38 months.
Safety population included all participants who received any amount of study treatment.
|
|
Vascular disorders
Deep vein thrombosis
|
4.9%
2/41 • Number of events 2 • All-cause mortality, non-serious advents (Non-SAEs) and serious adverse events (SAE) were collected up to 38 months.
Safety population included all participants who received any amount of study treatment.
|
|
Vascular disorders
Flushing
|
2.4%
1/41 • Number of events 1 • All-cause mortality, non-serious advents (Non-SAEs) and serious adverse events (SAE) were collected up to 38 months.
Safety population included all participants who received any amount of study treatment.
|
|
Vascular disorders
Thrombosis
|
2.4%
1/41 • Number of events 1 • All-cause mortality, non-serious advents (Non-SAEs) and serious adverse events (SAE) were collected up to 38 months.
Safety population included all participants who received any amount of study treatment.
|
|
Nervous system disorders
Headache
|
39.0%
16/41 • Number of events 23 • All-cause mortality, non-serious advents (Non-SAEs) and serious adverse events (SAE) were collected up to 38 months.
Safety population included all participants who received any amount of study treatment.
|
|
Nervous system disorders
Dizziness
|
9.8%
4/41 • Number of events 4 • All-cause mortality, non-serious advents (Non-SAEs) and serious adverse events (SAE) were collected up to 38 months.
Safety population included all participants who received any amount of study treatment.
|
|
Nervous system disorders
Dysgeusia
|
7.3%
3/41 • Number of events 3 • All-cause mortality, non-serious advents (Non-SAEs) and serious adverse events (SAE) were collected up to 38 months.
Safety population included all participants who received any amount of study treatment.
|
|
Nervous system disorders
Taste disorder
|
4.9%
2/41 • Number of events 2 • All-cause mortality, non-serious advents (Non-SAEs) and serious adverse events (SAE) were collected up to 38 months.
Safety population included all participants who received any amount of study treatment.
|
|
Nervous system disorders
Tremor
|
4.9%
2/41 • Number of events 2 • All-cause mortality, non-serious advents (Non-SAEs) and serious adverse events (SAE) were collected up to 38 months.
Safety population included all participants who received any amount of study treatment.
|
|
Nervous system disorders
Disturbance in attention
|
2.4%
1/41 • Number of events 1 • All-cause mortality, non-serious advents (Non-SAEs) and serious adverse events (SAE) were collected up to 38 months.
Safety population included all participants who received any amount of study treatment.
|
|
Nervous system disorders
Hypoaesthesia
|
2.4%
1/41 • Number of events 1 • All-cause mortality, non-serious advents (Non-SAEs) and serious adverse events (SAE) were collected up to 38 months.
Safety population included all participants who received any amount of study treatment.
|
|
Nervous system disorders
Lethargy
|
2.4%
1/41 • Number of events 2 • All-cause mortality, non-serious advents (Non-SAEs) and serious adverse events (SAE) were collected up to 38 months.
Safety population included all participants who received any amount of study treatment.
|
|
Nervous system disorders
Normal pressure hydrocephalus
|
2.4%
1/41 • Number of events 1 • All-cause mortality, non-serious advents (Non-SAEs) and serious adverse events (SAE) were collected up to 38 months.
Safety population included all participants who received any amount of study treatment.
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
2.4%
1/41 • Number of events 1 • All-cause mortality, non-serious advents (Non-SAEs) and serious adverse events (SAE) were collected up to 38 months.
Safety population included all participants who received any amount of study treatment.
|
|
Nervous system disorders
Post herpetic neuralgia
|
2.4%
1/41 • Number of events 1 • All-cause mortality, non-serious advents (Non-SAEs) and serious adverse events (SAE) were collected up to 38 months.
Safety population included all participants who received any amount of study treatment.
|
|
Nervous system disorders
Syncope
|
2.4%
1/41 • Number of events 1 • All-cause mortality, non-serious advents (Non-SAEs) and serious adverse events (SAE) were collected up to 38 months.
Safety population included all participants who received any amount of study treatment.
|
|
Infections and infestations
Urinary tract infection
|
12.2%
5/41 • Number of events 5 • All-cause mortality, non-serious advents (Non-SAEs) and serious adverse events (SAE) were collected up to 38 months.
Safety population included all participants who received any amount of study treatment.
|
|
Infections and infestations
Sinusitis
|
7.3%
3/41 • Number of events 3 • All-cause mortality, non-serious advents (Non-SAEs) and serious adverse events (SAE) were collected up to 38 months.
Safety population included all participants who received any amount of study treatment.
|
|
Infections and infestations
Upper respiratory tract infection
|
7.3%
3/41 • Number of events 3 • All-cause mortality, non-serious advents (Non-SAEs) and serious adverse events (SAE) were collected up to 38 months.
Safety population included all participants who received any amount of study treatment.
|
|
Infections and infestations
Abdominal abcess
|
2.4%
1/41 • Number of events 1 • All-cause mortality, non-serious advents (Non-SAEs) and serious adverse events (SAE) were collected up to 38 months.
Safety population included all participants who received any amount of study treatment.
|
|
Infections and infestations
Bronchitis
|
2.4%
1/41 • Number of events 1 • All-cause mortality, non-serious advents (Non-SAEs) and serious adverse events (SAE) were collected up to 38 months.
Safety population included all participants who received any amount of study treatment.
|
|
Infections and infestations
COVID-19
|
2.4%
1/41 • Number of events 1 • All-cause mortality, non-serious advents (Non-SAEs) and serious adverse events (SAE) were collected up to 38 months.
Safety population included all participants who received any amount of study treatment.
|
|
Infections and infestations
Catheter site cellulitis
|
2.4%
1/41 • Number of events 1 • All-cause mortality, non-serious advents (Non-SAEs) and serious adverse events (SAE) were collected up to 38 months.
Safety population included all participants who received any amount of study treatment.
|
|
Infections and infestations
Gastroenteritis
|
2.4%
1/41 • Number of events 1 • All-cause mortality, non-serious advents (Non-SAEs) and serious adverse events (SAE) were collected up to 38 months.
Safety population included all participants who received any amount of study treatment.
|
|
Infections and infestations
Herpes zoster
|
2.4%
1/41 • Number of events 1 • All-cause mortality, non-serious advents (Non-SAEs) and serious adverse events (SAE) were collected up to 38 months.
Safety population included all participants who received any amount of study treatment.
|
|
Infections and infestations
Infection
|
2.4%
1/41 • Number of events 1 • All-cause mortality, non-serious advents (Non-SAEs) and serious adverse events (SAE) were collected up to 38 months.
Safety population included all participants who received any amount of study treatment.
|
|
Infections and infestations
Lyme disease
|
2.4%
1/41 • Number of events 2 • All-cause mortality, non-serious advents (Non-SAEs) and serious adverse events (SAE) were collected up to 38 months.
Safety population included all participants who received any amount of study treatment.
|
|
Infections and infestations
Oesophageal candidiasis
|
2.4%
1/41 • Number of events 1 • All-cause mortality, non-serious advents (Non-SAEs) and serious adverse events (SAE) were collected up to 38 months.
Safety population included all participants who received any amount of study treatment.
|
|
Infections and infestations
Oral herpes
|
2.4%
1/41 • Number of events 1 • All-cause mortality, non-serious advents (Non-SAEs) and serious adverse events (SAE) were collected up to 38 months.
Safety population included all participants who received any amount of study treatment.
|
|
Infections and infestations
Pneumonia
|
2.4%
1/41 • Number of events 1 • All-cause mortality, non-serious advents (Non-SAEs) and serious adverse events (SAE) were collected up to 38 months.
Safety population included all participants who received any amount of study treatment.
|
|
Infections and infestations
Rash pustular
|
2.4%
1/41 • Number of events 1 • All-cause mortality, non-serious advents (Non-SAEs) and serious adverse events (SAE) were collected up to 38 months.
Safety population included all participants who received any amount of study treatment.
|
|
Infections and infestations
Rhinitis
|
2.4%
1/41 • Number of events 1 • All-cause mortality, non-serious advents (Non-SAEs) and serious adverse events (SAE) were collected up to 38 months.
Safety population included all participants who received any amount of study treatment.
|
|
Infections and infestations
Tooth abscess
|
2.4%
1/41 • Number of events 1 • All-cause mortality, non-serious advents (Non-SAEs) and serious adverse events (SAE) were collected up to 38 months.
Safety population included all participants who received any amount of study treatment.
|
|
Infections and infestations
Tooth infection
|
2.4%
1/41 • Number of events 1 • All-cause mortality, non-serious advents (Non-SAEs) and serious adverse events (SAE) were collected up to 38 months.
Safety population included all participants who received any amount of study treatment.
|
|
Infections and infestations
Viral infection
|
2.4%
1/41 • Number of events 1 • All-cause mortality, non-serious advents (Non-SAEs) and serious adverse events (SAE) were collected up to 38 months.
Safety population included all participants who received any amount of study treatment.
|
|
Infections and infestations
Viral rash
|
2.4%
1/41 • Number of events 1 • All-cause mortality, non-serious advents (Non-SAEs) and serious adverse events (SAE) were collected up to 38 months.
Safety population included all participants who received any amount of study treatment.
|
|
Psychiatric disorders
Insomnia
|
34.1%
14/41 • Number of events 21 • All-cause mortality, non-serious advents (Non-SAEs) and serious adverse events (SAE) were collected up to 38 months.
Safety population included all participants who received any amount of study treatment.
|
|
Psychiatric disorders
Anxiety
|
9.8%
4/41 • Number of events 4 • All-cause mortality, non-serious advents (Non-SAEs) and serious adverse events (SAE) were collected up to 38 months.
Safety population included all participants who received any amount of study treatment.
|
|
Psychiatric disorders
Nervousness
|
2.4%
1/41 • Number of events 2 • All-cause mortality, non-serious advents (Non-SAEs) and serious adverse events (SAE) were collected up to 38 months.
Safety population included all participants who received any amount of study treatment.
|
|
Psychiatric disorders
Sleep disorder
|
2.4%
1/41 • Number of events 2 • All-cause mortality, non-serious advents (Non-SAEs) and serious adverse events (SAE) were collected up to 38 months.
Safety population included all participants who received any amount of study treatment.
|
|
Renal and urinary disorders
Proteinuria
|
19.5%
8/41 • Number of events 18 • All-cause mortality, non-serious advents (Non-SAEs) and serious adverse events (SAE) were collected up to 38 months.
Safety population included all participants who received any amount of study treatment.
|
|
Renal and urinary disorders
Pollakiuria
|
9.8%
4/41 • Number of events 4 • All-cause mortality, non-serious advents (Non-SAEs) and serious adverse events (SAE) were collected up to 38 months.
Safety population included all participants who received any amount of study treatment.
|
|
Renal and urinary disorders
Dysuria
|
7.3%
3/41 • Number of events 3 • All-cause mortality, non-serious advents (Non-SAEs) and serious adverse events (SAE) were collected up to 38 months.
Safety population included all participants who received any amount of study treatment.
|
|
Renal and urinary disorders
Haematuria
|
2.4%
1/41 • Number of events 1 • All-cause mortality, non-serious advents (Non-SAEs) and serious adverse events (SAE) were collected up to 38 months.
Safety population included all participants who received any amount of study treatment.
|
|
Renal and urinary disorders
Stress urinary incontinence
|
2.4%
1/41 • Number of events 1 • All-cause mortality, non-serious advents (Non-SAEs) and serious adverse events (SAE) were collected up to 38 months.
Safety population included all participants who received any amount of study treatment.
|
|
Renal and urinary disorders
Urinary incontinence
|
2.4%
1/41 • Number of events 1 • All-cause mortality, non-serious advents (Non-SAEs) and serious adverse events (SAE) were collected up to 38 months.
Safety population included all participants who received any amount of study treatment.
|
|
Renal and urinary disorders
Urinary tract pain
|
2.4%
1/41 • Number of events 2 • All-cause mortality, non-serious advents (Non-SAEs) and serious adverse events (SAE) were collected up to 38 months.
Safety population included all participants who received any amount of study treatment.
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
9.8%
4/41 • Number of events 4 • All-cause mortality, non-serious advents (Non-SAEs) and serious adverse events (SAE) were collected up to 38 months.
Safety population included all participants who received any amount of study treatment.
|
|
Injury, poisoning and procedural complications
Contusion
|
4.9%
2/41 • Number of events 2 • All-cause mortality, non-serious advents (Non-SAEs) and serious adverse events (SAE) were collected up to 38 months.
Safety population included all participants who received any amount of study treatment.
|
|
Injury, poisoning and procedural complications
Skin abrasion
|
4.9%
2/41 • Number of events 2 • All-cause mortality, non-serious advents (Non-SAEs) and serious adverse events (SAE) were collected up to 38 months.
Safety population included all participants who received any amount of study treatment.
|
|
Injury, poisoning and procedural complications
Animal bite
|
2.4%
1/41 • Number of events 1 • All-cause mortality, non-serious advents (Non-SAEs) and serious adverse events (SAE) were collected up to 38 months.
Safety population included all participants who received any amount of study treatment.
|
|
Injury, poisoning and procedural complications
Fracture
|
2.4%
1/41 • Number of events 2 • All-cause mortality, non-serious advents (Non-SAEs) and serious adverse events (SAE) were collected up to 38 months.
Safety population included all participants who received any amount of study treatment.
|
|
Injury, poisoning and procedural complications
Post procedural contusion
|
2.4%
1/41 • Number of events 1 • All-cause mortality, non-serious advents (Non-SAEs) and serious adverse events (SAE) were collected up to 38 months.
Safety population included all participants who received any amount of study treatment.
|
|
Endocrine disorders
Hypothyroidism
|
17.1%
7/41 • Number of events 10 • All-cause mortality, non-serious advents (Non-SAEs) and serious adverse events (SAE) were collected up to 38 months.
Safety population included all participants who received any amount of study treatment.
|
|
Cardiac disorders
Sinus tachycardia
|
7.3%
3/41 • Number of events 3 • All-cause mortality, non-serious advents (Non-SAEs) and serious adverse events (SAE) were collected up to 38 months.
Safety population included all participants who received any amount of study treatment.
|
|
Cardiac disorders
Palpitations
|
4.9%
2/41 • Number of events 2 • All-cause mortality, non-serious advents (Non-SAEs) and serious adverse events (SAE) were collected up to 38 months.
Safety population included all participants who received any amount of study treatment.
|
|
Cardiac disorders
Cardiac failure
|
2.4%
1/41 • Number of events 1 • All-cause mortality, non-serious advents (Non-SAEs) and serious adverse events (SAE) were collected up to 38 months.
Safety population included all participants who received any amount of study treatment.
|
|
Cardiac disorders
Sinus bradycardia
|
2.4%
1/41 • Number of events 2 • All-cause mortality, non-serious advents (Non-SAEs) and serious adverse events (SAE) were collected up to 38 months.
Safety population included all participants who received any amount of study treatment.
|
|
Cardiac disorders
Tachycardia
|
2.4%
1/41 • Number of events 3 • All-cause mortality, non-serious advents (Non-SAEs) and serious adverse events (SAE) were collected up to 38 months.
Safety population included all participants who received any amount of study treatment.
|
|
Eye disorders
Vision blurred
|
7.3%
3/41 • Number of events 4 • All-cause mortality, non-serious advents (Non-SAEs) and serious adverse events (SAE) were collected up to 38 months.
Safety population included all participants who received any amount of study treatment.
|
|
Eye disorders
Cataract
|
4.9%
2/41 • Number of events 2 • All-cause mortality, non-serious advents (Non-SAEs) and serious adverse events (SAE) were collected up to 38 months.
Safety population included all participants who received any amount of study treatment.
|
|
Eye disorders
Eye pruritus
|
2.4%
1/41 • Number of events 1 • All-cause mortality, non-serious advents (Non-SAEs) and serious adverse events (SAE) were collected up to 38 months.
Safety population included all participants who received any amount of study treatment.
|
|
Eye disorders
Eye swelling
|
2.4%
1/41 • Number of events 1 • All-cause mortality, non-serious advents (Non-SAEs) and serious adverse events (SAE) were collected up to 38 months.
Safety population included all participants who received any amount of study treatment.
|
|
Eye disorders
Macular degeneration
|
2.4%
1/41 • Number of events 1 • All-cause mortality, non-serious advents (Non-SAEs) and serious adverse events (SAE) were collected up to 38 months.
Safety population included all participants who received any amount of study treatment.
|
|
Reproductive system and breast disorders
Pelvic pain
|
4.9%
2/41 • Number of events 2 • All-cause mortality, non-serious advents (Non-SAEs) and serious adverse events (SAE) were collected up to 38 months.
Safety population included all participants who received any amount of study treatment.
|
|
Reproductive system and breast disorders
Atrophic vulvovaginitis
|
2.4%
1/41 • Number of events 1 • All-cause mortality, non-serious advents (Non-SAEs) and serious adverse events (SAE) were collected up to 38 months.
Safety population included all participants who received any amount of study treatment.
|
|
Reproductive system and breast disorders
Genital rash
|
2.4%
1/41 • Number of events 1 • All-cause mortality, non-serious advents (Non-SAEs) and serious adverse events (SAE) were collected up to 38 months.
Safety population included all participants who received any amount of study treatment.
|
|
Reproductive system and breast disorders
Pelvic discomfort
|
2.4%
1/41 • Number of events 1 • All-cause mortality, non-serious advents (Non-SAEs) and serious adverse events (SAE) were collected up to 38 months.
Safety population included all participants who received any amount of study treatment.
|
|
Reproductive system and breast disorders
Vulvovaginal pain
|
2.4%
1/41 • Number of events 1 • All-cause mortality, non-serious advents (Non-SAEs) and serious adverse events (SAE) were collected up to 38 months.
Safety population included all participants who received any amount of study treatment.
|
|
Ear and labyrinth disorders
Ear discomfort
|
2.4%
1/41 • Number of events 1 • All-cause mortality, non-serious advents (Non-SAEs) and serious adverse events (SAE) were collected up to 38 months.
Safety population included all participants who received any amount of study treatment.
|
|
Ear and labyrinth disorders
Inner ear disorder
|
2.4%
1/41 • Number of events 2 • All-cause mortality, non-serious advents (Non-SAEs) and serious adverse events (SAE) were collected up to 38 months.
Safety population included all participants who received any amount of study treatment.
|
|
Immune system disorders
Drug hypersensitivity
|
2.4%
1/41 • Number of events 1 • All-cause mortality, non-serious advents (Non-SAEs) and serious adverse events (SAE) were collected up to 38 months.
Safety population included all participants who received any amount of study treatment.
|
|
Immune system disorders
Multiple allergies
|
2.4%
1/41 • Number of events 1 • All-cause mortality, non-serious advents (Non-SAEs) and serious adverse events (SAE) were collected up to 38 months.
Safety population included all participants who received any amount of study treatment.
|
|
Hepatobiliary disorders
Hyperbilirubinaemia
|
2.4%
1/41 • Number of events 1 • All-cause mortality, non-serious advents (Non-SAEs) and serious adverse events (SAE) were collected up to 38 months.
Safety population included all participants who received any amount of study treatment.
|
|
Surgical and medical procedures
Abdominal cavity drainage
|
2.4%
1/41 • Number of events 1 • All-cause mortality, non-serious advents (Non-SAEs) and serious adverse events (SAE) were collected up to 38 months.
Safety population included all participants who received any amount of study treatment.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
- Publication restrictions are in place
Restriction type: OTHER