Trial Outcomes & Findings for A Study of Niraparib Combined With Bevacizumab Maintenance Treatment in Participants With Advanced Ovarian Cancer Following Response on Front-Line Platinum-Based Chemotherapy (NCT NCT03326193)
NCT ID: NCT03326193
Last Updated: 2025-07-31
Results Overview
PFS rate at 18 months is defined as the percentage of participants who have not progressed or died within 18 months after niraparib combined with bevacizumab treatment initiation. Progression was assessed by response evaluation criteria in solid tumors (RECIST) version (v) 1.1 criteria per Investigator assessment and defined as a 20 percent (%) increase in the sum of the diameter of target lesions or unequivocal progression of existing non-target lesions. Survival rate is the percentage of participants without progression assessed by RECIST v1.1 or death by the landmark timepoint. Confidence intervals was constructed using exact method.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
105 participants
Primary outcome timeframe
At 18 months
Results posted on
2025-07-31
Participant Flow
Participant milestones
| Measure |
Niraparib + Bevacizumab
Participants received bevacizumab 15 milligram per kilogram (mg/kg) via a 30 minute intravenous (IV) infusion on Day 1 of each 21-day cycle. Niraparib (200 mg or 300 mg) was administered orally once a day continuously throughout each 21-day cycle. On Day 1 of each 21-day cycle, niraparib was administered upon completion of bevacizumab infusion.
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|---|---|
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Overall Study
STARTED
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105
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Overall Study
COMPLETED
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70
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Overall Study
NOT COMPLETED
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35
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Reasons for withdrawal
| Measure |
Niraparib + Bevacizumab
Participants received bevacizumab 15 milligram per kilogram (mg/kg) via a 30 minute intravenous (IV) infusion on Day 1 of each 21-day cycle. Niraparib (200 mg or 300 mg) was administered orally once a day continuously throughout each 21-day cycle. On Day 1 of each 21-day cycle, niraparib was administered upon completion of bevacizumab infusion.
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Overall Study
Sponsor decision
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35
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Baseline Characteristics
A Study of Niraparib Combined With Bevacizumab Maintenance Treatment in Participants With Advanced Ovarian Cancer Following Response on Front-Line Platinum-Based Chemotherapy
Baseline characteristics by cohort
| Measure |
Niraparib + Bevacizumab
n=105 Participants
Participants received bevacizumab 15 milligram per kilogram (mg/kg) via a 30 minute intravenous (IV) infusion on Day 1 of each 21-day cycle. Niraparib (200 mg or 300 mg) was administered orally once a day continuously throughout each 21-day cycle. On Day 1 of each 21-day cycle, niraparib was administered upon completion of bevacizumab infusion.
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Age, Continuous
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59.7 Years
STANDARD_DEVIATION 10.33 • n=5 Participants
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Sex: Female, Male
Female
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105 Participants
n=5 Participants
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Sex: Female, Male
Male
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0 Participants
n=5 Participants
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Race/Ethnicity, Customized
White
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91 Participants
n=5 Participants
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Race/Ethnicity, Customized
Black or African American
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4 Participants
n=5 Participants
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Race/Ethnicity, Customized
Asian
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3 Participants
n=5 Participants
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Race/Ethnicity, Customized
American Indian or Alaska Native
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1 Participants
n=5 Participants
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Race/Ethnicity, Customized
Unknown
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6 Participants
n=5 Participants
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PRIMARY outcome
Timeframe: At 18 monthsPopulation: Intent-to-treat (ITT) Population comprised of all participants who received any amount of niraparib (at least 1 dose).
PFS rate at 18 months is defined as the percentage of participants who have not progressed or died within 18 months after niraparib combined with bevacizumab treatment initiation. Progression was assessed by response evaluation criteria in solid tumors (RECIST) version (v) 1.1 criteria per Investigator assessment and defined as a 20 percent (%) increase in the sum of the diameter of target lesions or unequivocal progression of existing non-target lesions. Survival rate is the percentage of participants without progression assessed by RECIST v1.1 or death by the landmark timepoint. Confidence intervals was constructed using exact method.
Outcome measures
| Measure |
Niraparib + Bevacizumab
n=105 Participants
Participants received bevacizumab 15 milligram per kilogram (mg/kg) via a 30 minute intravenous (IV) infusion on Day 1 of each 21-day cycle. Niraparib (200 mg or 300 mg) was administered orally once a day continuously throughout each 21-day cycle. On Day 1 of each 21-day cycle, niraparib was administered upon completion of bevacizumab infusion.
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Progression Free Survival (PFS) Rate
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62 Percentage of participants
Interval 51.9 to 71.2
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SECONDARY outcome
Timeframe: Up to end of study (approximately 79 months)Population: ITT Population
PFS was defined as the time from treatment initiation with niraparib combined with bevacizumab to the earlier date of assessment of progression, as assessed by RECIST v1.1 criteria, based on Investigator assessment, or death by any cause in the absence of progression.
Outcome measures
| Measure |
Niraparib + Bevacizumab
n=105 Participants
Participants received bevacizumab 15 milligram per kilogram (mg/kg) via a 30 minute intravenous (IV) infusion on Day 1 of each 21-day cycle. Niraparib (200 mg or 300 mg) was administered orally once a day continuously throughout each 21-day cycle. On Day 1 of each 21-day cycle, niraparib was administered upon completion of bevacizumab infusion.
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Progression Free Survival (PFS) by RECIST v 1.1
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19.6 Months
Interval 16.56 to 25.07
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SECONDARY outcome
Timeframe: Up to end of study (approximately 79 months)Population: ITT Population
OS was defined as the date of initiation of niraparib treatment in combination with bevacizumab to the date of death by any cause.
Outcome measures
| Measure |
Niraparib + Bevacizumab
n=105 Participants
Participants received bevacizumab 15 milligram per kilogram (mg/kg) via a 30 minute intravenous (IV) infusion on Day 1 of each 21-day cycle. Niraparib (200 mg or 300 mg) was administered orally once a day continuously throughout each 21-day cycle. On Day 1 of each 21-day cycle, niraparib was administered upon completion of bevacizumab infusion.
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Overall Survival (OS)
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61.1 Months
Interval 44.88 to
The upper limit of the 95% confidence interval was not estimable at the time of the final analysis due to an insufficient number of participants with events within the length of follow-up in assessing the number of events
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SECONDARY outcome
Timeframe: Up to end of study (approximately 79 months)Population: ITT Population
RECIST or CA-125 progression-free survival is defined as the time from initiation of niraparib treatment in combination with bevacizumab to the earliest date of progression assessed by RECIST v1.1 or CA-125 progression or death by any cause. CA-125 progression is defined as participants with elevated CA-125 pretreatment and normalization of CA-125 that must show evidence of CA-125 ≥ 2 × upper limit of normal (ULN) on 2 occasions at least 1 week apart OR elevated CA-125 pretreatment that never normalizes and must show evidence of CA-125 ≥ 2 × the nadir value on 2 occasions at least 1 week apart OR elevated CA-125 in the normal range pretreatment that must show evidence of CA-125 ≥ 2 × ULN on 2 occasions at least 1 week apart.
Outcome measures
| Measure |
Niraparib + Bevacizumab
n=105 Participants
Participants received bevacizumab 15 milligram per kilogram (mg/kg) via a 30 minute intravenous (IV) infusion on Day 1 of each 21-day cycle. Niraparib (200 mg or 300 mg) was administered orally once a day continuously throughout each 21-day cycle. On Day 1 of each 21-day cycle, niraparib was administered upon completion of bevacizumab infusion.
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RECIST or Cancer Antigen (CA)-125 Progression Free Survival
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16.9 Months
Interval 13.27 to 22.05
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SECONDARY outcome
Timeframe: Baseline (Day 1), Cycles 3, 5, 7, 9, 13, 17, 21, 25, 29 (Each Cycle was of 21 days) and end of treatment (70 months)Population: ITT Population. Only those participants with data available at specified time points have been analyzed.
FOSI is a validated, 8-item measure of symptom response to treatment for ovarian cancer. Participants responded to their symptom experience over the past 7 days using a 5-point Likert scale scored from "not at all" (0) to "very much" (4). FOSI score was calculated as sum of item scores multiplied by 8 divided by number of items answered. The FOSI score ranged from 0 (severely symptomatic) to 32 (asymptomatic). A higher score indicated a better quality of life (QoL). Baseline (Day 1) is defined as the most recent measurement prior to the first administration of study drug (including Cycle 1 Day 1).
Outcome measures
| Measure |
Niraparib + Bevacizumab
n=105 Participants
Participants received bevacizumab 15 milligram per kilogram (mg/kg) via a 30 minute intravenous (IV) infusion on Day 1 of each 21-day cycle. Niraparib (200 mg or 300 mg) was administered orally once a day continuously throughout each 21-day cycle. On Day 1 of each 21-day cycle, niraparib was administered upon completion of bevacizumab infusion.
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Change From Baseline (CFB) in Functional Assessment of Cancer Therapy - Ovarian Symptom Index (FOSI)
CFB to Cycle 13
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-1.1 Scores on scale
Standard Deviation 4.25
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Change From Baseline (CFB) in Functional Assessment of Cancer Therapy - Ovarian Symptom Index (FOSI)
Baseline (Day 1)
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25.7 Scores on scale
Standard Deviation 3.79
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Change From Baseline (CFB) in Functional Assessment of Cancer Therapy - Ovarian Symptom Index (FOSI)
CFB to Cycle 3
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-1.4 Scores on scale
Standard Deviation 4.30
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Change From Baseline (CFB) in Functional Assessment of Cancer Therapy - Ovarian Symptom Index (FOSI)
CFB to Cycle 5
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-1.7 Scores on scale
Standard Deviation 3.89
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Change From Baseline (CFB) in Functional Assessment of Cancer Therapy - Ovarian Symptom Index (FOSI)
CFB to Cycle 9
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-1.1 Scores on scale
Standard Deviation 3.74
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Change From Baseline (CFB) in Functional Assessment of Cancer Therapy - Ovarian Symptom Index (FOSI)
CFB to Cycle 7
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-0.3 Scores on scale
Standard Deviation 3.09
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Change From Baseline (CFB) in Functional Assessment of Cancer Therapy - Ovarian Symptom Index (FOSI)
CFB to Cycle 17
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-0.7 Scores on scale
Standard Deviation 3.39
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Change From Baseline (CFB) in Functional Assessment of Cancer Therapy - Ovarian Symptom Index (FOSI)
CFB to Cycle 21
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-0.6 Scores on scale
Standard Deviation 3.77
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Change From Baseline (CFB) in Functional Assessment of Cancer Therapy - Ovarian Symptom Index (FOSI)
CFB to Cycle 25
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0.1 Scores on scale
Standard Deviation 3.73
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Change From Baseline (CFB) in Functional Assessment of Cancer Therapy - Ovarian Symptom Index (FOSI)
CFB to Cycle 29
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0.7 Scores on scale
Standard Deviation 3.40
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Change From Baseline (CFB) in Functional Assessment of Cancer Therapy - Ovarian Symptom Index (FOSI)
CFB to End of Treatment (70 months)
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-2.0 Scores on scale
Standard Deviation 5.21
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SECONDARY outcome
Timeframe: Up to end of study (approximately 79 months)Population: ITT Population
TFST was defined as the date of initiation of niraparib treatment in combination with bevacizumab treatment in the current study to the start date of the first subsequent anticancer therapy.
Outcome measures
| Measure |
Niraparib + Bevacizumab
n=105 Participants
Participants received bevacizumab 15 milligram per kilogram (mg/kg) via a 30 minute intravenous (IV) infusion on Day 1 of each 21-day cycle. Niraparib (200 mg or 300 mg) was administered orally once a day continuously throughout each 21-day cycle. On Day 1 of each 21-day cycle, niraparib was administered upon completion of bevacizumab infusion.
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Time to First Subsequent Therapy (TFST)
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17.5 Months
Interval 14.55 to 20.73
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SECONDARY outcome
Timeframe: Up to end of study (approximately 79 months)Population: ITT Population
TSST was defined as the date of initiation of treatment of niraparib in combination with bevacizumab treatment in the current study to the start date of the second subsequent anticancer therapy.
Outcome measures
| Measure |
Niraparib + Bevacizumab
n=105 Participants
Participants received bevacizumab 15 milligram per kilogram (mg/kg) via a 30 minute intravenous (IV) infusion on Day 1 of each 21-day cycle. Niraparib (200 mg or 300 mg) was administered orally once a day continuously throughout each 21-day cycle. On Day 1 of each 21-day cycle, niraparib was administered upon completion of bevacizumab infusion.
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Time to Second Subsequent Therapy (TSST)
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38.6 Months
Interval 30.55 to 55.85
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SECONDARY outcome
Timeframe: Up to end of treatment (70 months)Population: Safety Population included all participants who received any amount of study treatment (i.e. any amount of bevacizumab or niraparib during the study).
Adverse event (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. TEAEs is any AE that occurred for the first time after at least 1 dose of study treatment administration and until treatment duration. TEAEs which were not serious were considered as non-serious TEAEs. TESAE is defined as any untoward medical occurrence that, at any dose may result in death or is life-threatening or requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent disability/incapacity or is congenital anomaly/birth defect or any other situation according to medical or scientific judgment or is associated with liver injury and impaired liver function. AEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA) coding system. Percentages are rounded off to the nearest decimal point.
Outcome measures
| Measure |
Niraparib + Bevacizumab
n=105 Participants
Participants received bevacizumab 15 milligram per kilogram (mg/kg) via a 30 minute intravenous (IV) infusion on Day 1 of each 21-day cycle. Niraparib (200 mg or 300 mg) was administered orally once a day continuously throughout each 21-day cycle. On Day 1 of each 21-day cycle, niraparib was administered upon completion of bevacizumab infusion.
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Percentage of Participants With Treatment-emergent Adverse Events (TEAEs), Non-serious TEAEs and Treatment-emergent Serious Adverse Events (TESAEs)
TEAEs
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100 Percentage of participants
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Percentage of Participants With Treatment-emergent Adverse Events (TEAEs), Non-serious TEAEs and Treatment-emergent Serious Adverse Events (TESAEs)
Non-serious TEAEs
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100 Percentage of participants
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Percentage of Participants With Treatment-emergent Adverse Events (TEAEs), Non-serious TEAEs and Treatment-emergent Serious Adverse Events (TESAEs)
TESAEs
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30.5 Percentage of participants
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SECONDARY outcome
Timeframe: Up to end of treatment (70 months)Population: Safety Population
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. TEAE is any AE that occurred for the first time after at least 1 dose of study treatment administration. AEs were coded using the MedDRA coding system.
Outcome measures
| Measure |
Niraparib + Bevacizumab
n=105 Participants
Participants received bevacizumab 15 milligram per kilogram (mg/kg) via a 30 minute intravenous (IV) infusion on Day 1 of each 21-day cycle. Niraparib (200 mg or 300 mg) was administered orally once a day continuously throughout each 21-day cycle. On Day 1 of each 21-day cycle, niraparib was administered upon completion of bevacizumab infusion.
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Number of Participants With TEAEs Leading to Niraparib Treatment Discontinuation
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46 Participants
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SECONDARY outcome
Timeframe: Up to end of treatment (70 months)Population: Safety Population
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. TEAE is any AE that occurred for the first time after at least 1 dose of study treatment administration. AEs were coded using the MedDRA coding system.
Outcome measures
| Measure |
Niraparib + Bevacizumab
n=105 Participants
Participants received bevacizumab 15 milligram per kilogram (mg/kg) via a 30 minute intravenous (IV) infusion on Day 1 of each 21-day cycle. Niraparib (200 mg or 300 mg) was administered orally once a day continuously throughout each 21-day cycle. On Day 1 of each 21-day cycle, niraparib was administered upon completion of bevacizumab infusion.
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Number of Participants With TEAEs Leading to Niraparib Dose Reductions
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81 Participants
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SECONDARY outcome
Timeframe: Up to end of treatment (70 months)Population: Safety Population
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. AESIs of scientific and medical concern related to the treatment were monitored, and rapidly communicated by investigator to sponsor. AEs were coded using the MedDRA coding system.
Outcome measures
| Measure |
Niraparib + Bevacizumab
n=105 Participants
Participants received bevacizumab 15 milligram per kilogram (mg/kg) via a 30 minute intravenous (IV) infusion on Day 1 of each 21-day cycle. Niraparib (200 mg or 300 mg) was administered orally once a day continuously throughout each 21-day cycle. On Day 1 of each 21-day cycle, niraparib was administered upon completion of bevacizumab infusion.
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|---|---|
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Number of Participants With AEs of Special Interest (AESI)
New malignancies other than Myelodysplastic Syndromes (MDS) and Acute Myeloid Leukemia (AML)
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4 Participants
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Number of Participants With AEs of Special Interest (AESI)
MDS/AML Event
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2 Participants
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SECONDARY outcome
Timeframe: Baseline (Day 1) and end of treatment (70 months)Population: Safety Population. Only those participants with data available at specified time points have been analyzed.
Blood pressures (DBP and SBP) were measured after resting for at least 5 minutes in a supine or semi-recumbent position. Baseline (Day 1) is defined as the most recent measurement prior to the first administration of study drug (including Cycle 1 Day 1).
Outcome measures
| Measure |
Niraparib + Bevacizumab
n=105 Participants
Participants received bevacizumab 15 milligram per kilogram (mg/kg) via a 30 minute intravenous (IV) infusion on Day 1 of each 21-day cycle. Niraparib (200 mg or 300 mg) was administered orally once a day continuously throughout each 21-day cycle. On Day 1 of each 21-day cycle, niraparib was administered upon completion of bevacizumab infusion.
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Change From Baseline (CFB) in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)
SBP: Baseline (Day 1)
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129.7 Millimeter of mercury (mmHg)
Standard Deviation 15.87
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Change From Baseline (CFB) in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)
SBP: CFB to End of Treatment (70 months)
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2.8 Millimeter of mercury (mmHg)
Standard Deviation 21.70
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Change From Baseline (CFB) in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)
DBP: Baseline (Day 1)
|
78.2 Millimeter of mercury (mmHg)
Standard Deviation 9.30
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Change From Baseline (CFB) in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)
DBP: CFB to End of Treatment (70 months)
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0.3 Millimeter of mercury (mmHg)
Standard Deviation 11.17
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SECONDARY outcome
Timeframe: Baseline (Day 1) and end of treatment (70 months)Population: Safety Population. Only those participants with data available at specified time points have been analyzed.
Pulse Rate was measured after resting for at least 5 minutes in a supine or semi-recumbent position. Baseline (Day 1) is defined as the most recent measurement prior to the first administration of study drug (including Cycle 1 Day 1).
Outcome measures
| Measure |
Niraparib + Bevacizumab
n=105 Participants
Participants received bevacizumab 15 milligram per kilogram (mg/kg) via a 30 minute intravenous (IV) infusion on Day 1 of each 21-day cycle. Niraparib (200 mg or 300 mg) was administered orally once a day continuously throughout each 21-day cycle. On Day 1 of each 21-day cycle, niraparib was administered upon completion of bevacizumab infusion.
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|---|---|
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Change From Baseline (CFB) in Pulse Rate
Baseline (Day 1)
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80.6 Beats/minute
Standard Deviation 11.40
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Change From Baseline (CFB) in Pulse Rate
CFB to End of Treatment (70 months)
|
4.3 Beats/minute
Standard Deviation 13.12
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SECONDARY outcome
Timeframe: Baseline (Day 1) and end of treatment (70 months)Population: Safety Population. Only those participants with data available at specified time points have been analyzed.
Temperature was measured after resting for at least 5 minutes in a supine or semi-recumbent position. Baseline (Day 1) is defined as the most recent measurement prior to the first administration of study drug (including Cycle 1 Day 1).
Outcome measures
| Measure |
Niraparib + Bevacizumab
n=105 Participants
Participants received bevacizumab 15 milligram per kilogram (mg/kg) via a 30 minute intravenous (IV) infusion on Day 1 of each 21-day cycle. Niraparib (200 mg or 300 mg) was administered orally once a day continuously throughout each 21-day cycle. On Day 1 of each 21-day cycle, niraparib was administered upon completion of bevacizumab infusion.
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Change From Baseline (CFB) in Temperature
Baseline (Day 1)
|
36.59 Celsius
Standard Deviation 0.297
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Change From Baseline (CFB) in Temperature
CFB to End of Treatment (70 months)
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-0.01 Celsius
Standard Deviation 0.439
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SECONDARY outcome
Timeframe: Up to end of treatment (70 months)Population: Safety Population
Any permitted concomitant medication(s), including non-prescription medication(s) and herbal product(s), taken during the study were recorded.
Outcome measures
| Measure |
Niraparib + Bevacizumab
n=105 Participants
Participants received bevacizumab 15 milligram per kilogram (mg/kg) via a 30 minute intravenous (IV) infusion on Day 1 of each 21-day cycle. Niraparib (200 mg or 300 mg) was administered orally once a day continuously throughout each 21-day cycle. On Day 1 of each 21-day cycle, niraparib was administered upon completion of bevacizumab infusion.
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|---|---|
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Number of Participants Who Used Concomitant Medications
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100 Participants
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SECONDARY outcome
Timeframe: Baseline (Day 1) and end of treatment (70 months)Population: Safety population. Only those participants with data available at specified time points have been analyzed.
Blood samples were collected for the assessment of change from Baseline in hematology parameters. Baseline (Day 1) is defined as the most recent measurement prior to the first administration of study drug (including Cycle 1 Day 1).
Outcome measures
| Measure |
Niraparib + Bevacizumab
n=105 Participants
Participants received bevacizumab 15 milligram per kilogram (mg/kg) via a 30 minute intravenous (IV) infusion on Day 1 of each 21-day cycle. Niraparib (200 mg or 300 mg) was administered orally once a day continuously throughout each 21-day cycle. On Day 1 of each 21-day cycle, niraparib was administered upon completion of bevacizumab infusion.
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|---|---|
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Change From Baseline (CFB) in Hematology Parameters: Basophils, Eosinophil, Leukocytes, Platelets, Lymphocytes, Monocytes and Neutrophils
Basophils: Baseline (Day 1)
|
0.025 Giga cells per liter (10^9 cells/L)
Standard Deviation 0.0320
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Change From Baseline (CFB) in Hematology Parameters: Basophils, Eosinophil, Leukocytes, Platelets, Lymphocytes, Monocytes and Neutrophils
Basophils: CFB to End of Treatment (70 months)
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0.008 Giga cells per liter (10^9 cells/L)
Standard Deviation 0.0385
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Change From Baseline (CFB) in Hematology Parameters: Basophils, Eosinophil, Leukocytes, Platelets, Lymphocytes, Monocytes and Neutrophils
Eosinophil: Baseline (Day 1)
|
0.168 Giga cells per liter (10^9 cells/L)
Standard Deviation 0.3071
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Change From Baseline (CFB) in Hematology Parameters: Basophils, Eosinophil, Leukocytes, Platelets, Lymphocytes, Monocytes and Neutrophils
Eosinophil: CFB to End of Treatment (70 months)
|
-0.028 Giga cells per liter (10^9 cells/L)
Standard Deviation 0.3245
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Change From Baseline (CFB) in Hematology Parameters: Basophils, Eosinophil, Leukocytes, Platelets, Lymphocytes, Monocytes and Neutrophils
Leukocytes: Baseline (Day 1)
|
5.523 Giga cells per liter (10^9 cells/L)
Standard Deviation 1.5398
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Change From Baseline (CFB) in Hematology Parameters: Basophils, Eosinophil, Leukocytes, Platelets, Lymphocytes, Monocytes and Neutrophils
Leukocytes: CFB to End of Treatment (70 months)
|
0.660 Giga cells per liter (10^9 cells/L)
Standard Deviation 3.9571
|
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Change From Baseline (CFB) in Hematology Parameters: Basophils, Eosinophil, Leukocytes, Platelets, Lymphocytes, Monocytes and Neutrophils
Platelets: Baseline (Day 1)
|
219.810 Giga cells per liter (10^9 cells/L)
Standard Deviation 79.5186
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Change From Baseline (CFB) in Hematology Parameters: Basophils, Eosinophil, Leukocytes, Platelets, Lymphocytes, Monocytes and Neutrophils
Platelets: CFB to End of Treatment (70 months)
|
-6.585 Giga cells per liter (10^9 cells/L)
Standard Deviation 74.0943
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Change From Baseline (CFB) in Hematology Parameters: Basophils, Eosinophil, Leukocytes, Platelets, Lymphocytes, Monocytes and Neutrophils
Lymphocytes: Baseline (Day 1)
|
1.694 Giga cells per liter (10^9 cells/L)
Standard Deviation 0.6216
|
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Change From Baseline (CFB) in Hematology Parameters: Basophils, Eosinophil, Leukocytes, Platelets, Lymphocytes, Monocytes and Neutrophils
Lymphocytes: CFB to End of Treatment (70 months)
|
0.152 Giga cells per liter (10^9 cells/L)
Standard Deviation 2.1904
|
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Change From Baseline (CFB) in Hematology Parameters: Basophils, Eosinophil, Leukocytes, Platelets, Lymphocytes, Monocytes and Neutrophils
Monocytes: Baseline (Day 1)
|
0.492 Giga cells per liter (10^9 cells/L)
Standard Deviation 0.2137
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Change From Baseline (CFB) in Hematology Parameters: Basophils, Eosinophil, Leukocytes, Platelets, Lymphocytes, Monocytes and Neutrophils
Monocytes: CFB to End of Treatment (70 months)
|
0.007 Giga cells per liter (10^9 cells/L)
Standard Deviation 0.1819
|
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Change From Baseline (CFB) in Hematology Parameters: Basophils, Eosinophil, Leukocytes, Platelets, Lymphocytes, Monocytes and Neutrophils
Neutrophils: Baseline (Day 1)
|
3.135 Giga cells per liter (10^9 cells/L)
Standard Deviation 1.1369
|
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Change From Baseline (CFB) in Hematology Parameters: Basophils, Eosinophil, Leukocytes, Platelets, Lymphocytes, Monocytes and Neutrophils
Neutrophils: CFB to End of Treatment (70 months)
|
0.197 Giga cells per liter (10^9 cells/L)
Standard Deviation 1.6063
|
SECONDARY outcome
Timeframe: Baseline (Day 1) and end of treatment (70 months)Population: Safety population. Only those participants with data available at specified time points have been analyzed.
Blood samples were collected for the assessment of change from Baseline in hematology parameter. Baseline (Day 1) is defined as the most recent measurement prior to the first administration of study drug (including Cycle 1 Day 1).
Outcome measures
| Measure |
Niraparib + Bevacizumab
n=105 Participants
Participants received bevacizumab 15 milligram per kilogram (mg/kg) via a 30 minute intravenous (IV) infusion on Day 1 of each 21-day cycle. Niraparib (200 mg or 300 mg) was administered orally once a day continuously throughout each 21-day cycle. On Day 1 of each 21-day cycle, niraparib was administered upon completion of bevacizumab infusion.
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|---|---|
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Change From Baseline (CFB) in Hematology Parameter: Hemoglobin (Hb)
Baseline (Day 1)
|
116.800 Grams per liter (g/L)
Standard Deviation 10.0234
|
|
Change From Baseline (CFB) in Hematology Parameter: Hemoglobin (Hb)
CFB to End of Treatment (70 months)
|
4.787 Grams per liter (g/L)
Standard Deviation 14.4303
|
SECONDARY outcome
Timeframe: Baseline (Day 1) and end of treatment (70 months)Population: Safety population. Only those participants with data available at specified time points have been analyzed.
Blood samples were collected for the assessment of change from Baseline in hematology parameter. Baseline (Day 1) is defined as the most recent measurement prior to the first administration of study drug (including Cycle 1 Day 1).
Outcome measures
| Measure |
Niraparib + Bevacizumab
n=105 Participants
Participants received bevacizumab 15 milligram per kilogram (mg/kg) via a 30 minute intravenous (IV) infusion on Day 1 of each 21-day cycle. Niraparib (200 mg or 300 mg) was administered orally once a day continuously throughout each 21-day cycle. On Day 1 of each 21-day cycle, niraparib was administered upon completion of bevacizumab infusion.
|
|---|---|
|
Change From Baseline (CFB) in Hematology Parameter: Erythrocyte Mean Corpuscular Volume (MCV)
Baseline (Day 1)
|
97.560 Femtoliters (fL)
Standard Deviation 7.0779
|
|
Change From Baseline (CFB) in Hematology Parameter: Erythrocyte Mean Corpuscular Volume (MCV)
CFB to End of Treatment (70 months)
|
0.093 Femtoliters (fL)
Standard Deviation 5.4536
|
SECONDARY outcome
Timeframe: Baseline (Day 1) and end of treatment (70 months)Population: Safety population. Only those participants with data available at specified time points have been analyzed.
Blood samples were collected for the assessment of change from Baseline in clinical chemistry parameters. Baseline (Day 1) is defined as the most recent measurement prior to the first administration of study drug (including Cycle 1 Day 1).
Outcome measures
| Measure |
Niraparib + Bevacizumab
n=105 Participants
Participants received bevacizumab 15 milligram per kilogram (mg/kg) via a 30 minute intravenous (IV) infusion on Day 1 of each 21-day cycle. Niraparib (200 mg or 300 mg) was administered orally once a day continuously throughout each 21-day cycle. On Day 1 of each 21-day cycle, niraparib was administered upon completion of bevacizumab infusion.
|
|---|---|
|
Change From Baseline (CFB) in Clinical Chemistry Parameters: Urea Nitrogen, Glucose, Calcium, Chloride, Sodium, Magnesium and Potassium
Urea Nitrogen: Baseline (Day 1)
|
5.681 Millimoles per liter (mmol/L)
Standard Deviation 1.7222
|
|
Change From Baseline (CFB) in Clinical Chemistry Parameters: Urea Nitrogen, Glucose, Calcium, Chloride, Sodium, Magnesium and Potassium
Urea Nitrogen: CFB to End of Treatment (70 months)
|
0.375 Millimoles per liter (mmol/L)
Standard Deviation 2.1948
|
|
Change From Baseline (CFB) in Clinical Chemistry Parameters: Urea Nitrogen, Glucose, Calcium, Chloride, Sodium, Magnesium and Potassium
Glucose: Baseline (Day 1)
|
5.996 Millimoles per liter (mmol/L)
Standard Deviation 2.3156
|
|
Change From Baseline (CFB) in Clinical Chemistry Parameters: Urea Nitrogen, Glucose, Calcium, Chloride, Sodium, Magnesium and Potassium
Glucose: CFB to End of Treatment (70 months)
|
-0.073 Millimoles per liter (mmol/L)
Standard Deviation 2.8001
|
|
Change From Baseline (CFB) in Clinical Chemistry Parameters: Urea Nitrogen, Glucose, Calcium, Chloride, Sodium, Magnesium and Potassium
Calcium: Baseline (Day 1)
|
2.377 Millimoles per liter (mmol/L)
Standard Deviation 0.0872
|
|
Change From Baseline (CFB) in Clinical Chemistry Parameters: Urea Nitrogen, Glucose, Calcium, Chloride, Sodium, Magnesium and Potassium
Calcium: CFB to End of Treatment (70 months)
|
0.018 Millimoles per liter (mmol/L)
Standard Deviation 0.1005
|
|
Change From Baseline (CFB) in Clinical Chemistry Parameters: Urea Nitrogen, Glucose, Calcium, Chloride, Sodium, Magnesium and Potassium
Chloride: Baseline (Day 1)
|
102.747 Millimoles per liter (mmol/L)
Standard Deviation 2.9885
|
|
Change From Baseline (CFB) in Clinical Chemistry Parameters: Urea Nitrogen, Glucose, Calcium, Chloride, Sodium, Magnesium and Potassium
Chloride: CFB to End of Treatment (70 months)
|
-0.536 Millimoles per liter (mmol/L)
Standard Deviation 3.4272
|
|
Change From Baseline (CFB) in Clinical Chemistry Parameters: Urea Nitrogen, Glucose, Calcium, Chloride, Sodium, Magnesium and Potassium
Sodium: Baseline (Day 1)
|
139.467 Millimoles per liter (mmol/L)
Standard Deviation 2.8184
|
|
Change From Baseline (CFB) in Clinical Chemistry Parameters: Urea Nitrogen, Glucose, Calcium, Chloride, Sodium, Magnesium and Potassium
Sodium: CFB to End of Treatment (70 months)
|
-0.298 Millimoles per liter (mmol/L)
Standard Deviation 2.7192
|
|
Change From Baseline (CFB) in Clinical Chemistry Parameters: Urea Nitrogen, Glucose, Calcium, Chloride, Sodium, Magnesium and Potassium
Magnesium: Baseline (Day 1)
|
0.764 Millimoles per liter (mmol/L)
Standard Deviation 0.1024
|
|
Change From Baseline (CFB) in Clinical Chemistry Parameters: Urea Nitrogen, Glucose, Calcium, Chloride, Sodium, Magnesium and Potassium
Magnesium: CFB to End of Treatment (70 months)
|
0.017 Millimoles per liter (mmol/L)
Standard Deviation 0.0977
|
|
Change From Baseline (CFB) in Clinical Chemistry Parameters: Urea Nitrogen, Glucose, Calcium, Chloride, Sodium, Magnesium and Potassium
Potassium: Baseline (Day 1)
|
4.206 Millimoles per liter (mmol/L)
Standard Deviation 0.3860
|
|
Change From Baseline (CFB) in Clinical Chemistry Parameters: Urea Nitrogen, Glucose, Calcium, Chloride, Sodium, Magnesium and Potassium
Potassium: CFB to End of Treatment (70 months)
|
0.031 Millimoles per liter (mmol/L)
Standard Deviation 0.4891
|
SECONDARY outcome
Timeframe: Baseline (Day 1) and end of treatment (70 months)Population: Safety population. Only those participants with data available at specified time points have been analyzed.
Blood samples were collected for the assessment of change from Baseline in clinical chemistry parameters. Baseline (Day 1) is defined as the most recent measurement prior to the first administration of study drug (including Cycle 1 Day 1).
Outcome measures
| Measure |
Niraparib + Bevacizumab
n=105 Participants
Participants received bevacizumab 15 milligram per kilogram (mg/kg) via a 30 minute intravenous (IV) infusion on Day 1 of each 21-day cycle. Niraparib (200 mg or 300 mg) was administered orally once a day continuously throughout each 21-day cycle. On Day 1 of each 21-day cycle, niraparib was administered upon completion of bevacizumab infusion.
|
|---|---|
|
Change From Baseline (CFB) in Clinical Chemistry Parameters: Bilirubin and Creatinine
Bilirubin: Baseline (Day 1)
|
6.242 Micromoles per liter (umol/L)
Standard Deviation 2.8546
|
|
Change From Baseline (CFB) in Clinical Chemistry Parameters: Bilirubin and Creatinine
Bilirubin: CFB to End of Treatment (70 months)
|
1.168 Micromoles per liter (umol/L)
Standard Deviation 3.2660
|
|
Change From Baseline (CFB) in Clinical Chemistry Parameters: Bilirubin and Creatinine
Creatinine: Baseline (Day 1)
|
65.577 Micromoles per liter (umol/L)
Standard Deviation 16.3865
|
|
Change From Baseline (CFB) in Clinical Chemistry Parameters: Bilirubin and Creatinine
Creatinine: CFB to End of Treatment (70 months)
|
9.339 Micromoles per liter (umol/L)
Standard Deviation 16.4405
|
SECONDARY outcome
Timeframe: Baseline (Day 1) and end of treatment (70 months)Population: Safety population. Only those participants with data available at specified time points have been analyzed.
Blood samples were collected for the assessment of change from baseline in clinical chemistry parameters. Baseline (Day 1) is defined as the most recent measurement prior to the first administration of study drug (including Cycle 1 Day 1).
Outcome measures
| Measure |
Niraparib + Bevacizumab
n=105 Participants
Participants received bevacizumab 15 milligram per kilogram (mg/kg) via a 30 minute intravenous (IV) infusion on Day 1 of each 21-day cycle. Niraparib (200 mg or 300 mg) was administered orally once a day continuously throughout each 21-day cycle. On Day 1 of each 21-day cycle, niraparib was administered upon completion of bevacizumab infusion.
|
|---|---|
|
Change From Baseline (CFB) in Clinical Chemistry Parameters: Albumin and Protein
Albumin: Baseline (Day 1)
|
41.629 Grams per liter (g/L)
Standard Deviation 3.3748
|
|
Change From Baseline (CFB) in Clinical Chemistry Parameters: Albumin and Protein
Albumin: CFB to End of Treatment (70 months)
|
0.926 Grams per liter (g/L)
Standard Deviation 3.1902
|
|
Change From Baseline (CFB) in Clinical Chemistry Parameters: Albumin and Protein
Protein: Baseline (Day 1)
|
70.619 Grams per liter (g/L)
Standard Deviation 5.0676
|
|
Change From Baseline (CFB) in Clinical Chemistry Parameters: Albumin and Protein
Protein: CFB to End of Treatment (70 months)
|
0.309 Grams per liter (g/L)
Standard Deviation 4.5744
|
SECONDARY outcome
Timeframe: Baseline (Day 1) and end of treatment (70 months)Population: Safety population. Only those participants with data available at specified time points have been analyzed.
Blood samples were collected for the assessment of change from baseline in clinical chemistry parameters. Baseline (Day 1) is defined as the most recent measurement prior to the first administration of study drug (including Cycle 1 Day 1).
Outcome measures
| Measure |
Niraparib + Bevacizumab
n=105 Participants
Participants received bevacizumab 15 milligram per kilogram (mg/kg) via a 30 minute intravenous (IV) infusion on Day 1 of each 21-day cycle. Niraparib (200 mg or 300 mg) was administered orally once a day continuously throughout each 21-day cycle. On Day 1 of each 21-day cycle, niraparib was administered upon completion of bevacizumab infusion.
|
|---|---|
|
Change From Baseline (CFB) in Clinical Chemistry Parameters: Aspartate Aminotransferase (AST) and Alanine Aminotransferase (ALT)
AST: Baseline (Day 1)
|
24.619 International units per Liter (IU/L)
Standard Deviation 12.0043
|
|
Change From Baseline (CFB) in Clinical Chemistry Parameters: Aspartate Aminotransferase (AST) and Alanine Aminotransferase (ALT)
AST: CFB to End of Treatment (70 months)
|
5.117 International units per Liter (IU/L)
Standard Deviation 20.0863
|
|
Change From Baseline (CFB) in Clinical Chemistry Parameters: Aspartate Aminotransferase (AST) and Alanine Aminotransferase (ALT)
ALT: Baseline (Day 1)
|
23.590 International units per Liter (IU/L)
Standard Deviation 13.4241
|
|
Change From Baseline (CFB) in Clinical Chemistry Parameters: Aspartate Aminotransferase (AST) and Alanine Aminotransferase (ALT)
ALT: CFB to End of Treatment (70 months)
|
4.362 International units per Liter (IU/L)
Standard Deviation 19.3484
|
Adverse Events
Niraparib + Bevacizumab
Serious events: 32 serious events
Other events: 105 other events
Deaths: 56 deaths
Serious adverse events
| Measure |
Niraparib + Bevacizumab
n=105 participants at risk
Participants received bevacizumab 15 milligram per kilogram (mg/kg) via a 30 minute intravenous (IV) infusion on Day 1 of each 21-day cycle. Niraparib (200 mg or 300 mg) was administered orally once a day continuously throughout each 21-day cycle. On Day 1 of each 21-day cycle, niraparib was administered upon completion of bevacizumab infusion.
|
|---|---|
|
Psychiatric disorders
Mania
|
0.95%
1/105 • All-cause mortality was collected up to approximately 79 months (end of study) and treatment emergent non-serious adverse events and serious adverse events were collected up to 70 months (end of treatment).
Safety Population included all participants who received any amount of study treatment (i.e. any amount of bevacizumab or niraparib during the study). All-cause mortality was reported for all enrolled participants
|
|
Reproductive system and breast disorders
Rectocele
|
0.95%
1/105 • All-cause mortality was collected up to approximately 79 months (end of study) and treatment emergent non-serious adverse events and serious adverse events were collected up to 70 months (end of treatment).
Safety Population included all participants who received any amount of study treatment (i.e. any amount of bevacizumab or niraparib during the study). All-cause mortality was reported for all enrolled participants
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Myelodysplastic syndrome
|
0.95%
1/105 • All-cause mortality was collected up to approximately 79 months (end of study) and treatment emergent non-serious adverse events and serious adverse events were collected up to 70 months (end of treatment).
Safety Population included all participants who received any amount of study treatment (i.e. any amount of bevacizumab or niraparib during the study). All-cause mortality was reported for all enrolled participants
|
|
Reproductive system and breast disorders
Cystocele
|
0.95%
1/105 • All-cause mortality was collected up to approximately 79 months (end of study) and treatment emergent non-serious adverse events and serious adverse events were collected up to 70 months (end of treatment).
Safety Population included all participants who received any amount of study treatment (i.e. any amount of bevacizumab or niraparib during the study). All-cause mortality was reported for all enrolled participants
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
5.7%
6/105 • All-cause mortality was collected up to approximately 79 months (end of study) and treatment emergent non-serious adverse events and serious adverse events were collected up to 70 months (end of treatment).
Safety Population included all participants who received any amount of study treatment (i.e. any amount of bevacizumab or niraparib during the study). All-cause mortality was reported for all enrolled participants
|
|
Blood and lymphatic system disorders
Anaemia
|
0.95%
1/105 • All-cause mortality was collected up to approximately 79 months (end of study) and treatment emergent non-serious adverse events and serious adverse events were collected up to 70 months (end of treatment).
Safety Population included all participants who received any amount of study treatment (i.e. any amount of bevacizumab or niraparib during the study). All-cause mortality was reported for all enrolled participants
|
|
Blood and lymphatic system disorders
Pancytopenia
|
0.95%
1/105 • All-cause mortality was collected up to approximately 79 months (end of study) and treatment emergent non-serious adverse events and serious adverse events were collected up to 70 months (end of treatment).
Safety Population included all participants who received any amount of study treatment (i.e. any amount of bevacizumab or niraparib during the study). All-cause mortality was reported for all enrolled participants
|
|
Investigations
Platelet count decreased
|
7.6%
8/105 • All-cause mortality was collected up to approximately 79 months (end of study) and treatment emergent non-serious adverse events and serious adverse events were collected up to 70 months (end of treatment).
Safety Population included all participants who received any amount of study treatment (i.e. any amount of bevacizumab or niraparib during the study). All-cause mortality was reported for all enrolled participants
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
1.9%
2/105 • All-cause mortality was collected up to approximately 79 months (end of study) and treatment emergent non-serious adverse events and serious adverse events were collected up to 70 months (end of treatment).
Safety Population included all participants who received any amount of study treatment (i.e. any amount of bevacizumab or niraparib during the study). All-cause mortality was reported for all enrolled participants
|
|
Gastrointestinal disorders
Dysphagia
|
0.95%
1/105 • All-cause mortality was collected up to approximately 79 months (end of study) and treatment emergent non-serious adverse events and serious adverse events were collected up to 70 months (end of treatment).
Safety Population included all participants who received any amount of study treatment (i.e. any amount of bevacizumab or niraparib during the study). All-cause mortality was reported for all enrolled participants
|
|
Gastrointestinal disorders
Lower gastrointestinal haemorrhage
|
0.95%
1/105 • All-cause mortality was collected up to approximately 79 months (end of study) and treatment emergent non-serious adverse events and serious adverse events were collected up to 70 months (end of treatment).
Safety Population included all participants who received any amount of study treatment (i.e. any amount of bevacizumab or niraparib during the study). All-cause mortality was reported for all enrolled participants
|
|
General disorders
Chest pain
|
1.9%
2/105 • All-cause mortality was collected up to approximately 79 months (end of study) and treatment emergent non-serious adverse events and serious adverse events were collected up to 70 months (end of treatment).
Safety Population included all participants who received any amount of study treatment (i.e. any amount of bevacizumab or niraparib during the study). All-cause mortality was reported for all enrolled participants
|
|
General disorders
Pyrexia
|
0.95%
1/105 • All-cause mortality was collected up to approximately 79 months (end of study) and treatment emergent non-serious adverse events and serious adverse events were collected up to 70 months (end of treatment).
Safety Population included all participants who received any amount of study treatment (i.e. any amount of bevacizumab or niraparib during the study). All-cause mortality was reported for all enrolled participants
|
|
Infections and infestations
Appendicitis
|
0.95%
1/105 • All-cause mortality was collected up to approximately 79 months (end of study) and treatment emergent non-serious adverse events and serious adverse events were collected up to 70 months (end of treatment).
Safety Population included all participants who received any amount of study treatment (i.e. any amount of bevacizumab or niraparib during the study). All-cause mortality was reported for all enrolled participants
|
|
Infections and infestations
Clostridium difficile colitis
|
0.95%
1/105 • All-cause mortality was collected up to approximately 79 months (end of study) and treatment emergent non-serious adverse events and serious adverse events were collected up to 70 months (end of treatment).
Safety Population included all participants who received any amount of study treatment (i.e. any amount of bevacizumab or niraparib during the study). All-cause mortality was reported for all enrolled participants
|
|
Infections and infestations
Sepsis
|
0.95%
1/105 • All-cause mortality was collected up to approximately 79 months (end of study) and treatment emergent non-serious adverse events and serious adverse events were collected up to 70 months (end of treatment).
Safety Population included all participants who received any amount of study treatment (i.e. any amount of bevacizumab or niraparib during the study). All-cause mortality was reported for all enrolled participants
|
|
Infections and infestations
Skin infection
|
0.95%
1/105 • All-cause mortality was collected up to approximately 79 months (end of study) and treatment emergent non-serious adverse events and serious adverse events were collected up to 70 months (end of treatment).
Safety Population included all participants who received any amount of study treatment (i.e. any amount of bevacizumab or niraparib during the study). All-cause mortality was reported for all enrolled participants
|
|
Nervous system disorders
Headache
|
0.95%
1/105 • All-cause mortality was collected up to approximately 79 months (end of study) and treatment emergent non-serious adverse events and serious adverse events were collected up to 70 months (end of treatment).
Safety Population included all participants who received any amount of study treatment (i.e. any amount of bevacizumab or niraparib during the study). All-cause mortality was reported for all enrolled participants
|
|
Nervous system disorders
Neuropathy peripheral
|
0.95%
1/105 • All-cause mortality was collected up to approximately 79 months (end of study) and treatment emergent non-serious adverse events and serious adverse events were collected up to 70 months (end of treatment).
Safety Population included all participants who received any amount of study treatment (i.e. any amount of bevacizumab or niraparib during the study). All-cause mortality was reported for all enrolled participants
|
|
Nervous system disorders
Posterior reversible encephalopathy syndrome
|
0.95%
1/105 • All-cause mortality was collected up to approximately 79 months (end of study) and treatment emergent non-serious adverse events and serious adverse events were collected up to 70 months (end of treatment).
Safety Population included all participants who received any amount of study treatment (i.e. any amount of bevacizumab or niraparib during the study). All-cause mortality was reported for all enrolled participants
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.95%
1/105 • All-cause mortality was collected up to approximately 79 months (end of study) and treatment emergent non-serious adverse events and serious adverse events were collected up to 70 months (end of treatment).
Safety Population included all participants who received any amount of study treatment (i.e. any amount of bevacizumab or niraparib during the study). All-cause mortality was reported for all enrolled participants
|
|
Psychiatric disorders
Bipolar disorder
|
0.95%
1/105 • All-cause mortality was collected up to approximately 79 months (end of study) and treatment emergent non-serious adverse events and serious adverse events were collected up to 70 months (end of treatment).
Safety Population included all participants who received any amount of study treatment (i.e. any amount of bevacizumab or niraparib during the study). All-cause mortality was reported for all enrolled participants
|
|
Psychiatric disorders
Anxiety
|
0.95%
1/105 • All-cause mortality was collected up to approximately 79 months (end of study) and treatment emergent non-serious adverse events and serious adverse events were collected up to 70 months (end of treatment).
Safety Population included all participants who received any amount of study treatment (i.e. any amount of bevacizumab or niraparib during the study). All-cause mortality was reported for all enrolled participants
|
|
Vascular disorders
Hypertension
|
1.9%
2/105 • All-cause mortality was collected up to approximately 79 months (end of study) and treatment emergent non-serious adverse events and serious adverse events were collected up to 70 months (end of treatment).
Safety Population included all participants who received any amount of study treatment (i.e. any amount of bevacizumab or niraparib during the study). All-cause mortality was reported for all enrolled participants
|
|
Cardiac disorders
Acute coronary syndrome
|
0.95%
1/105 • All-cause mortality was collected up to approximately 79 months (end of study) and treatment emergent non-serious adverse events and serious adverse events were collected up to 70 months (end of treatment).
Safety Population included all participants who received any amount of study treatment (i.e. any amount of bevacizumab or niraparib during the study). All-cause mortality was reported for all enrolled participants
|
|
Injury, poisoning and procedural complications
Spinal fracture
|
0.95%
1/105 • All-cause mortality was collected up to approximately 79 months (end of study) and treatment emergent non-serious adverse events and serious adverse events were collected up to 70 months (end of treatment).
Safety Population included all participants who received any amount of study treatment (i.e. any amount of bevacizumab or niraparib during the study). All-cause mortality was reported for all enrolled participants
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Acute myeloid leukaemia
|
0.95%
1/105 • All-cause mortality was collected up to approximately 79 months (end of study) and treatment emergent non-serious adverse events and serious adverse events were collected up to 70 months (end of treatment).
Safety Population included all participants who received any amount of study treatment (i.e. any amount of bevacizumab or niraparib during the study). All-cause mortality was reported for all enrolled participants
|
|
Reproductive system and breast disorders
Vaginal haemorrhage
|
0.95%
1/105 • All-cause mortality was collected up to approximately 79 months (end of study) and treatment emergent non-serious adverse events and serious adverse events were collected up to 70 months (end of treatment).
Safety Population included all participants who received any amount of study treatment (i.e. any amount of bevacizumab or niraparib during the study). All-cause mortality was reported for all enrolled participants
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.95%
1/105 • All-cause mortality was collected up to approximately 79 months (end of study) and treatment emergent non-serious adverse events and serious adverse events were collected up to 70 months (end of treatment).
Safety Population included all participants who received any amount of study treatment (i.e. any amount of bevacizumab or niraparib during the study). All-cause mortality was reported for all enrolled participants
|
|
Metabolism and nutrition disorders
Hypervolaemia
|
0.95%
1/105 • All-cause mortality was collected up to approximately 79 months (end of study) and treatment emergent non-serious adverse events and serious adverse events were collected up to 70 months (end of treatment).
Safety Population included all participants who received any amount of study treatment (i.e. any amount of bevacizumab or niraparib during the study). All-cause mortality was reported for all enrolled participants
|
|
Psychiatric disorders
Depression
|
0.95%
1/105 • All-cause mortality was collected up to approximately 79 months (end of study) and treatment emergent non-serious adverse events and serious adverse events were collected up to 70 months (end of treatment).
Safety Population included all participants who received any amount of study treatment (i.e. any amount of bevacizumab or niraparib during the study). All-cause mortality was reported for all enrolled participants
|
Other adverse events
| Measure |
Niraparib + Bevacizumab
n=105 participants at risk
Participants received bevacizumab 15 milligram per kilogram (mg/kg) via a 30 minute intravenous (IV) infusion on Day 1 of each 21-day cycle. Niraparib (200 mg or 300 mg) was administered orally once a day continuously throughout each 21-day cycle. On Day 1 of each 21-day cycle, niraparib was administered upon completion of bevacizumab infusion.
|
|---|---|
|
Gastrointestinal disorders
Nausea
|
61.9%
65/105 • All-cause mortality was collected up to approximately 79 months (end of study) and treatment emergent non-serious adverse events and serious adverse events were collected up to 70 months (end of treatment).
Safety Population included all participants who received any amount of study treatment (i.e. any amount of bevacizumab or niraparib during the study). All-cause mortality was reported for all enrolled participants
|
|
Gastrointestinal disorders
Constipation
|
38.1%
40/105 • All-cause mortality was collected up to approximately 79 months (end of study) and treatment emergent non-serious adverse events and serious adverse events were collected up to 70 months (end of treatment).
Safety Population included all participants who received any amount of study treatment (i.e. any amount of bevacizumab or niraparib during the study). All-cause mortality was reported for all enrolled participants
|
|
Gastrointestinal disorders
Abdominal pain
|
32.4%
34/105 • All-cause mortality was collected up to approximately 79 months (end of study) and treatment emergent non-serious adverse events and serious adverse events were collected up to 70 months (end of treatment).
Safety Population included all participants who received any amount of study treatment (i.e. any amount of bevacizumab or niraparib during the study). All-cause mortality was reported for all enrolled participants
|
|
Gastrointestinal disorders
Vomiting
|
31.4%
33/105 • All-cause mortality was collected up to approximately 79 months (end of study) and treatment emergent non-serious adverse events and serious adverse events were collected up to 70 months (end of treatment).
Safety Population included all participants who received any amount of study treatment (i.e. any amount of bevacizumab or niraparib during the study). All-cause mortality was reported for all enrolled participants
|
|
Gastrointestinal disorders
Diarrhoea
|
29.5%
31/105 • All-cause mortality was collected up to approximately 79 months (end of study) and treatment emergent non-serious adverse events and serious adverse events were collected up to 70 months (end of treatment).
Safety Population included all participants who received any amount of study treatment (i.e. any amount of bevacizumab or niraparib during the study). All-cause mortality was reported for all enrolled participants
|
|
Gastrointestinal disorders
Stomatitis
|
19.0%
20/105 • All-cause mortality was collected up to approximately 79 months (end of study) and treatment emergent non-serious adverse events and serious adverse events were collected up to 70 months (end of treatment).
Safety Population included all participants who received any amount of study treatment (i.e. any amount of bevacizumab or niraparib during the study). All-cause mortality was reported for all enrolled participants
|
|
Gastrointestinal disorders
Abdominal distension
|
13.3%
14/105 • All-cause mortality was collected up to approximately 79 months (end of study) and treatment emergent non-serious adverse events and serious adverse events were collected up to 70 months (end of treatment).
Safety Population included all participants who received any amount of study treatment (i.e. any amount of bevacizumab or niraparib during the study). All-cause mortality was reported for all enrolled participants
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
7.6%
8/105 • All-cause mortality was collected up to approximately 79 months (end of study) and treatment emergent non-serious adverse events and serious adverse events were collected up to 70 months (end of treatment).
Safety Population included all participants who received any amount of study treatment (i.e. any amount of bevacizumab or niraparib during the study). All-cause mortality was reported for all enrolled participants
|
|
Gastrointestinal disorders
Dry mouth
|
6.7%
7/105 • All-cause mortality was collected up to approximately 79 months (end of study) and treatment emergent non-serious adverse events and serious adverse events were collected up to 70 months (end of treatment).
Safety Population included all participants who received any amount of study treatment (i.e. any amount of bevacizumab or niraparib during the study). All-cause mortality was reported for all enrolled participants
|
|
Gastrointestinal disorders
Abdominal pain lower
|
5.7%
6/105 • All-cause mortality was collected up to approximately 79 months (end of study) and treatment emergent non-serious adverse events and serious adverse events were collected up to 70 months (end of treatment).
Safety Population included all participants who received any amount of study treatment (i.e. any amount of bevacizumab or niraparib during the study). All-cause mortality was reported for all enrolled participants
|
|
Gastrointestinal disorders
Dyspepsia
|
6.7%
7/105 • All-cause mortality was collected up to approximately 79 months (end of study) and treatment emergent non-serious adverse events and serious adverse events were collected up to 70 months (end of treatment).
Safety Population included all participants who received any amount of study treatment (i.e. any amount of bevacizumab or niraparib during the study). All-cause mortality was reported for all enrolled participants
|
|
General disorders
Fatigue
|
68.6%
72/105 • All-cause mortality was collected up to approximately 79 months (end of study) and treatment emergent non-serious adverse events and serious adverse events were collected up to 70 months (end of treatment).
Safety Population included all participants who received any amount of study treatment (i.e. any amount of bevacizumab or niraparib during the study). All-cause mortality was reported for all enrolled participants
|
|
General disorders
Oedema peripheral
|
15.2%
16/105 • All-cause mortality was collected up to approximately 79 months (end of study) and treatment emergent non-serious adverse events and serious adverse events were collected up to 70 months (end of treatment).
Safety Population included all participants who received any amount of study treatment (i.e. any amount of bevacizumab or niraparib during the study). All-cause mortality was reported for all enrolled participants
|
|
General disorders
Asthenia
|
9.5%
10/105 • All-cause mortality was collected up to approximately 79 months (end of study) and treatment emergent non-serious adverse events and serious adverse events were collected up to 70 months (end of treatment).
Safety Population included all participants who received any amount of study treatment (i.e. any amount of bevacizumab or niraparib during the study). All-cause mortality was reported for all enrolled participants
|
|
General disorders
Chills
|
5.7%
6/105 • All-cause mortality was collected up to approximately 79 months (end of study) and treatment emergent non-serious adverse events and serious adverse events were collected up to 70 months (end of treatment).
Safety Population included all participants who received any amount of study treatment (i.e. any amount of bevacizumab or niraparib during the study). All-cause mortality was reported for all enrolled participants
|
|
General disorders
Pain
|
5.7%
6/105 • All-cause mortality was collected up to approximately 79 months (end of study) and treatment emergent non-serious adverse events and serious adverse events were collected up to 70 months (end of treatment).
Safety Population included all participants who received any amount of study treatment (i.e. any amount of bevacizumab or niraparib during the study). All-cause mortality was reported for all enrolled participants
|
|
General disorders
Pyrexia
|
5.7%
6/105 • All-cause mortality was collected up to approximately 79 months (end of study) and treatment emergent non-serious adverse events and serious adverse events were collected up to 70 months (end of treatment).
Safety Population included all participants who received any amount of study treatment (i.e. any amount of bevacizumab or niraparib during the study). All-cause mortality was reported for all enrolled participants
|
|
Nervous system disorders
Headache
|
56.2%
59/105 • All-cause mortality was collected up to approximately 79 months (end of study) and treatment emergent non-serious adverse events and serious adverse events were collected up to 70 months (end of treatment).
Safety Population included all participants who received any amount of study treatment (i.e. any amount of bevacizumab or niraparib during the study). All-cause mortality was reported for all enrolled participants
|
|
Nervous system disorders
Dizziness
|
29.5%
31/105 • All-cause mortality was collected up to approximately 79 months (end of study) and treatment emergent non-serious adverse events and serious adverse events were collected up to 70 months (end of treatment).
Safety Population included all participants who received any amount of study treatment (i.e. any amount of bevacizumab or niraparib during the study). All-cause mortality was reported for all enrolled participants
|
|
Nervous system disorders
Neuropathy peripheral
|
13.3%
14/105 • All-cause mortality was collected up to approximately 79 months (end of study) and treatment emergent non-serious adverse events and serious adverse events were collected up to 70 months (end of treatment).
Safety Population included all participants who received any amount of study treatment (i.e. any amount of bevacizumab or niraparib during the study). All-cause mortality was reported for all enrolled participants
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
9.5%
10/105 • All-cause mortality was collected up to approximately 79 months (end of study) and treatment emergent non-serious adverse events and serious adverse events were collected up to 70 months (end of treatment).
Safety Population included all participants who received any amount of study treatment (i.e. any amount of bevacizumab or niraparib during the study). All-cause mortality was reported for all enrolled participants
|
|
Nervous system disorders
Memory impairment
|
6.7%
7/105 • All-cause mortality was collected up to approximately 79 months (end of study) and treatment emergent non-serious adverse events and serious adverse events were collected up to 70 months (end of treatment).
Safety Population included all participants who received any amount of study treatment (i.e. any amount of bevacizumab or niraparib during the study). All-cause mortality was reported for all enrolled participants
|
|
Nervous system disorders
Dysgeusia
|
5.7%
6/105 • All-cause mortality was collected up to approximately 79 months (end of study) and treatment emergent non-serious adverse events and serious adverse events were collected up to 70 months (end of treatment).
Safety Population included all participants who received any amount of study treatment (i.e. any amount of bevacizumab or niraparib during the study). All-cause mortality was reported for all enrolled participants
|
|
Blood and lymphatic system disorders
Anaemia
|
52.4%
55/105 • All-cause mortality was collected up to approximately 79 months (end of study) and treatment emergent non-serious adverse events and serious adverse events were collected up to 70 months (end of treatment).
Safety Population included all participants who received any amount of study treatment (i.e. any amount of bevacizumab or niraparib during the study). All-cause mortality was reported for all enrolled participants
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
34.3%
36/105 • All-cause mortality was collected up to approximately 79 months (end of study) and treatment emergent non-serious adverse events and serious adverse events were collected up to 70 months (end of treatment).
Safety Population included all participants who received any amount of study treatment (i.e. any amount of bevacizumab or niraparib during the study). All-cause mortality was reported for all enrolled participants
|
|
Blood and lymphatic system disorders
Neutropenia
|
14.3%
15/105 • All-cause mortality was collected up to approximately 79 months (end of study) and treatment emergent non-serious adverse events and serious adverse events were collected up to 70 months (end of treatment).
Safety Population included all participants who received any amount of study treatment (i.e. any amount of bevacizumab or niraparib during the study). All-cause mortality was reported for all enrolled participants
|
|
Blood and lymphatic system disorders
Leukopenia
|
6.7%
7/105 • All-cause mortality was collected up to approximately 79 months (end of study) and treatment emergent non-serious adverse events and serious adverse events were collected up to 70 months (end of treatment).
Safety Population included all participants who received any amount of study treatment (i.e. any amount of bevacizumab or niraparib during the study). All-cause mortality was reported for all enrolled participants
|
|
Investigations
Platelet count decreased
|
40.0%
42/105 • All-cause mortality was collected up to approximately 79 months (end of study) and treatment emergent non-serious adverse events and serious adverse events were collected up to 70 months (end of treatment).
Safety Population included all participants who received any amount of study treatment (i.e. any amount of bevacizumab or niraparib during the study). All-cause mortality was reported for all enrolled participants
|
|
Investigations
White blood cell count decreased
|
21.9%
23/105 • All-cause mortality was collected up to approximately 79 months (end of study) and treatment emergent non-serious adverse events and serious adverse events were collected up to 70 months (end of treatment).
Safety Population included all participants who received any amount of study treatment (i.e. any amount of bevacizumab or niraparib during the study). All-cause mortality was reported for all enrolled participants
|
|
Investigations
Neutrophil count decreased
|
17.1%
18/105 • All-cause mortality was collected up to approximately 79 months (end of study) and treatment emergent non-serious adverse events and serious adverse events were collected up to 70 months (end of treatment).
Safety Population included all participants who received any amount of study treatment (i.e. any amount of bevacizumab or niraparib during the study). All-cause mortality was reported for all enrolled participants
|
|
Investigations
Activated partial thromboplastin time prolonged
|
13.3%
14/105 • All-cause mortality was collected up to approximately 79 months (end of study) and treatment emergent non-serious adverse events and serious adverse events were collected up to 70 months (end of treatment).
Safety Population included all participants who received any amount of study treatment (i.e. any amount of bevacizumab or niraparib during the study). All-cause mortality was reported for all enrolled participants
|
|
Investigations
Blood creatinine increased
|
10.5%
11/105 • All-cause mortality was collected up to approximately 79 months (end of study) and treatment emergent non-serious adverse events and serious adverse events were collected up to 70 months (end of treatment).
Safety Population included all participants who received any amount of study treatment (i.e. any amount of bevacizumab or niraparib during the study). All-cause mortality was reported for all enrolled participants
|
|
Investigations
Alanine aminotransferase increased
|
7.6%
8/105 • All-cause mortality was collected up to approximately 79 months (end of study) and treatment emergent non-serious adverse events and serious adverse events were collected up to 70 months (end of treatment).
Safety Population included all participants who received any amount of study treatment (i.e. any amount of bevacizumab or niraparib during the study). All-cause mortality was reported for all enrolled participants
|
|
Investigations
Aspartate aminotransferase increased
|
8.6%
9/105 • All-cause mortality was collected up to approximately 79 months (end of study) and treatment emergent non-serious adverse events and serious adverse events were collected up to 70 months (end of treatment).
Safety Population included all participants who received any amount of study treatment (i.e. any amount of bevacizumab or niraparib during the study). All-cause mortality was reported for all enrolled participants
|
|
Investigations
Weight increased
|
6.7%
7/105 • All-cause mortality was collected up to approximately 79 months (end of study) and treatment emergent non-serious adverse events and serious adverse events were collected up to 70 months (end of treatment).
Safety Population included all participants who received any amount of study treatment (i.e. any amount of bevacizumab or niraparib during the study). All-cause mortality was reported for all enrolled participants
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
36.2%
38/105 • All-cause mortality was collected up to approximately 79 months (end of study) and treatment emergent non-serious adverse events and serious adverse events were collected up to 70 months (end of treatment).
Safety Population included all participants who received any amount of study treatment (i.e. any amount of bevacizumab or niraparib during the study). All-cause mortality was reported for all enrolled participants
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
20.0%
21/105 • All-cause mortality was collected up to approximately 79 months (end of study) and treatment emergent non-serious adverse events and serious adverse events were collected up to 70 months (end of treatment).
Safety Population included all participants who received any amount of study treatment (i.e. any amount of bevacizumab or niraparib during the study). All-cause mortality was reported for all enrolled participants
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
19.0%
20/105 • All-cause mortality was collected up to approximately 79 months (end of study) and treatment emergent non-serious adverse events and serious adverse events were collected up to 70 months (end of treatment).
Safety Population included all participants who received any amount of study treatment (i.e. any amount of bevacizumab or niraparib during the study). All-cause mortality was reported for all enrolled participants
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
16.2%
17/105 • All-cause mortality was collected up to approximately 79 months (end of study) and treatment emergent non-serious adverse events and serious adverse events were collected up to 70 months (end of treatment).
Safety Population included all participants who received any amount of study treatment (i.e. any amount of bevacizumab or niraparib during the study). All-cause mortality was reported for all enrolled participants
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
13.3%
14/105 • All-cause mortality was collected up to approximately 79 months (end of study) and treatment emergent non-serious adverse events and serious adverse events were collected up to 70 months (end of treatment).
Safety Population included all participants who received any amount of study treatment (i.e. any amount of bevacizumab or niraparib during the study). All-cause mortality was reported for all enrolled participants
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
10.5%
11/105 • All-cause mortality was collected up to approximately 79 months (end of study) and treatment emergent non-serious adverse events and serious adverse events were collected up to 70 months (end of treatment).
Safety Population included all participants who received any amount of study treatment (i.e. any amount of bevacizumab or niraparib during the study). All-cause mortality was reported for all enrolled participants
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
10.5%
11/105 • All-cause mortality was collected up to approximately 79 months (end of study) and treatment emergent non-serious adverse events and serious adverse events were collected up to 70 months (end of treatment).
Safety Population included all participants who received any amount of study treatment (i.e. any amount of bevacizumab or niraparib during the study). All-cause mortality was reported for all enrolled participants
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
6.7%
7/105 • All-cause mortality was collected up to approximately 79 months (end of study) and treatment emergent non-serious adverse events and serious adverse events were collected up to 70 months (end of treatment).
Safety Population included all participants who received any amount of study treatment (i.e. any amount of bevacizumab or niraparib during the study). All-cause mortality was reported for all enrolled participants
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
34.3%
36/105 • All-cause mortality was collected up to approximately 79 months (end of study) and treatment emergent non-serious adverse events and serious adverse events were collected up to 70 months (end of treatment).
Safety Population included all participants who received any amount of study treatment (i.e. any amount of bevacizumab or niraparib during the study). All-cause mortality was reported for all enrolled participants
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
26.7%
28/105 • All-cause mortality was collected up to approximately 79 months (end of study) and treatment emergent non-serious adverse events and serious adverse events were collected up to 70 months (end of treatment).
Safety Population included all participants who received any amount of study treatment (i.e. any amount of bevacizumab or niraparib during the study). All-cause mortality was reported for all enrolled participants
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
22.9%
24/105 • All-cause mortality was collected up to approximately 79 months (end of study) and treatment emergent non-serious adverse events and serious adverse events were collected up to 70 months (end of treatment).
Safety Population included all participants who received any amount of study treatment (i.e. any amount of bevacizumab or niraparib during the study). All-cause mortality was reported for all enrolled participants
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
11.4%
12/105 • All-cause mortality was collected up to approximately 79 months (end of study) and treatment emergent non-serious adverse events and serious adverse events were collected up to 70 months (end of treatment).
Safety Population included all participants who received any amount of study treatment (i.e. any amount of bevacizumab or niraparib during the study). All-cause mortality was reported for all enrolled participants
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
9.5%
10/105 • All-cause mortality was collected up to approximately 79 months (end of study) and treatment emergent non-serious adverse events and serious adverse events were collected up to 70 months (end of treatment).
Safety Population included all participants who received any amount of study treatment (i.e. any amount of bevacizumab or niraparib during the study). All-cause mortality was reported for all enrolled participants
|
|
Infections and infestations
Urinary tract infection
|
27.6%
29/105 • All-cause mortality was collected up to approximately 79 months (end of study) and treatment emergent non-serious adverse events and serious adverse events were collected up to 70 months (end of treatment).
Safety Population included all participants who received any amount of study treatment (i.e. any amount of bevacizumab or niraparib during the study). All-cause mortality was reported for all enrolled participants
|
|
Infections and infestations
Upper respiratory tract infection
|
12.4%
13/105 • All-cause mortality was collected up to approximately 79 months (end of study) and treatment emergent non-serious adverse events and serious adverse events were collected up to 70 months (end of treatment).
Safety Population included all participants who received any amount of study treatment (i.e. any amount of bevacizumab or niraparib during the study). All-cause mortality was reported for all enrolled participants
|
|
Infections and infestations
Nasopharyngitis
|
8.6%
9/105 • All-cause mortality was collected up to approximately 79 months (end of study) and treatment emergent non-serious adverse events and serious adverse events were collected up to 70 months (end of treatment).
Safety Population included all participants who received any amount of study treatment (i.e. any amount of bevacizumab or niraparib during the study). All-cause mortality was reported for all enrolled participants
|
|
Infections and infestations
Sinusitis
|
7.6%
8/105 • All-cause mortality was collected up to approximately 79 months (end of study) and treatment emergent non-serious adverse events and serious adverse events were collected up to 70 months (end of treatment).
Safety Population included all participants who received any amount of study treatment (i.e. any amount of bevacizumab or niraparib during the study). All-cause mortality was reported for all enrolled participants
|
|
Vascular disorders
Hypertension
|
54.3%
57/105 • All-cause mortality was collected up to approximately 79 months (end of study) and treatment emergent non-serious adverse events and serious adverse events were collected up to 70 months (end of treatment).
Safety Population included all participants who received any amount of study treatment (i.e. any amount of bevacizumab or niraparib during the study). All-cause mortality was reported for all enrolled participants
|
|
Vascular disorders
Hot flush
|
14.3%
15/105 • All-cause mortality was collected up to approximately 79 months (end of study) and treatment emergent non-serious adverse events and serious adverse events were collected up to 70 months (end of treatment).
Safety Population included all participants who received any amount of study treatment (i.e. any amount of bevacizumab or niraparib during the study). All-cause mortality was reported for all enrolled participants
|
|
Renal and urinary disorders
Proteinuria
|
41.0%
43/105 • All-cause mortality was collected up to approximately 79 months (end of study) and treatment emergent non-serious adverse events and serious adverse events were collected up to 70 months (end of treatment).
Safety Population included all participants who received any amount of study treatment (i.e. any amount of bevacizumab or niraparib during the study). All-cause mortality was reported for all enrolled participants
|
|
Renal and urinary disorders
Haematuria
|
8.6%
9/105 • All-cause mortality was collected up to approximately 79 months (end of study) and treatment emergent non-serious adverse events and serious adverse events were collected up to 70 months (end of treatment).
Safety Population included all participants who received any amount of study treatment (i.e. any amount of bevacizumab or niraparib during the study). All-cause mortality was reported for all enrolled participants
|
|
Renal and urinary disorders
Pollakiuria
|
7.6%
8/105 • All-cause mortality was collected up to approximately 79 months (end of study) and treatment emergent non-serious adverse events and serious adverse events were collected up to 70 months (end of treatment).
Safety Population included all participants who received any amount of study treatment (i.e. any amount of bevacizumab or niraparib during the study). All-cause mortality was reported for all enrolled participants
|
|
Metabolism and nutrition disorders
Decreased appetite
|
17.1%
18/105 • All-cause mortality was collected up to approximately 79 months (end of study) and treatment emergent non-serious adverse events and serious adverse events were collected up to 70 months (end of treatment).
Safety Population included all participants who received any amount of study treatment (i.e. any amount of bevacizumab or niraparib during the study). All-cause mortality was reported for all enrolled participants
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
14.3%
15/105 • All-cause mortality was collected up to approximately 79 months (end of study) and treatment emergent non-serious adverse events and serious adverse events were collected up to 70 months (end of treatment).
Safety Population included all participants who received any amount of study treatment (i.e. any amount of bevacizumab or niraparib during the study). All-cause mortality was reported for all enrolled participants
|
|
Metabolism and nutrition disorders
Dehydration
|
9.5%
10/105 • All-cause mortality was collected up to approximately 79 months (end of study) and treatment emergent non-serious adverse events and serious adverse events were collected up to 70 months (end of treatment).
Safety Population included all participants who received any amount of study treatment (i.e. any amount of bevacizumab or niraparib during the study). All-cause mortality was reported for all enrolled participants
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
8.6%
9/105 • All-cause mortality was collected up to approximately 79 months (end of study) and treatment emergent non-serious adverse events and serious adverse events were collected up to 70 months (end of treatment).
Safety Population included all participants who received any amount of study treatment (i.e. any amount of bevacizumab or niraparib during the study). All-cause mortality was reported for all enrolled participants
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
8.6%
9/105 • All-cause mortality was collected up to approximately 79 months (end of study) and treatment emergent non-serious adverse events and serious adverse events were collected up to 70 months (end of treatment).
Safety Population included all participants who received any amount of study treatment (i.e. any amount of bevacizumab or niraparib during the study). All-cause mortality was reported for all enrolled participants
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
8.6%
9/105 • All-cause mortality was collected up to approximately 79 months (end of study) and treatment emergent non-serious adverse events and serious adverse events were collected up to 70 months (end of treatment).
Safety Population included all participants who received any amount of study treatment (i.e. any amount of bevacizumab or niraparib during the study). All-cause mortality was reported for all enrolled participants
|
|
Skin and subcutaneous tissue disorders
Rash
|
11.4%
12/105 • All-cause mortality was collected up to approximately 79 months (end of study) and treatment emergent non-serious adverse events and serious adverse events were collected up to 70 months (end of treatment).
Safety Population included all participants who received any amount of study treatment (i.e. any amount of bevacizumab or niraparib during the study). All-cause mortality was reported for all enrolled participants
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
6.7%
7/105 • All-cause mortality was collected up to approximately 79 months (end of study) and treatment emergent non-serious adverse events and serious adverse events were collected up to 70 months (end of treatment).
Safety Population included all participants who received any amount of study treatment (i.e. any amount of bevacizumab or niraparib during the study). All-cause mortality was reported for all enrolled participants
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
5.7%
6/105 • All-cause mortality was collected up to approximately 79 months (end of study) and treatment emergent non-serious adverse events and serious adverse events were collected up to 70 months (end of treatment).
Safety Population included all participants who received any amount of study treatment (i.e. any amount of bevacizumab or niraparib during the study). All-cause mortality was reported for all enrolled participants
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
5.7%
6/105 • All-cause mortality was collected up to approximately 79 months (end of study) and treatment emergent non-serious adverse events and serious adverse events were collected up to 70 months (end of treatment).
Safety Population included all participants who received any amount of study treatment (i.e. any amount of bevacizumab or niraparib during the study). All-cause mortality was reported for all enrolled participants
|
|
Psychiatric disorders
Insomnia
|
21.0%
22/105 • All-cause mortality was collected up to approximately 79 months (end of study) and treatment emergent non-serious adverse events and serious adverse events were collected up to 70 months (end of treatment).
Safety Population included all participants who received any amount of study treatment (i.e. any amount of bevacizumab or niraparib during the study). All-cause mortality was reported for all enrolled participants
|
|
Psychiatric disorders
Anxiety
|
12.4%
13/105 • All-cause mortality was collected up to approximately 79 months (end of study) and treatment emergent non-serious adverse events and serious adverse events were collected up to 70 months (end of treatment).
Safety Population included all participants who received any amount of study treatment (i.e. any amount of bevacizumab or niraparib during the study). All-cause mortality was reported for all enrolled participants
|
|
Psychiatric disorders
Depression
|
9.5%
10/105 • All-cause mortality was collected up to approximately 79 months (end of study) and treatment emergent non-serious adverse events and serious adverse events were collected up to 70 months (end of treatment).
Safety Population included all participants who received any amount of study treatment (i.e. any amount of bevacizumab or niraparib during the study). All-cause mortality was reported for all enrolled participants
|
|
Cardiac disorders
Palpitations
|
11.4%
12/105 • All-cause mortality was collected up to approximately 79 months (end of study) and treatment emergent non-serious adverse events and serious adverse events were collected up to 70 months (end of treatment).
Safety Population included all participants who received any amount of study treatment (i.e. any amount of bevacizumab or niraparib during the study). All-cause mortality was reported for all enrolled participants
|
|
Cardiac disorders
Tachycardia
|
9.5%
10/105 • All-cause mortality was collected up to approximately 79 months (end of study) and treatment emergent non-serious adverse events and serious adverse events were collected up to 70 months (end of treatment).
Safety Population included all participants who received any amount of study treatment (i.e. any amount of bevacizumab or niraparib during the study). All-cause mortality was reported for all enrolled participants
|
|
Injury, poisoning and procedural complications
Contusion
|
8.6%
9/105 • All-cause mortality was collected up to approximately 79 months (end of study) and treatment emergent non-serious adverse events and serious adverse events were collected up to 70 months (end of treatment).
Safety Population included all participants who received any amount of study treatment (i.e. any amount of bevacizumab or niraparib during the study). All-cause mortality was reported for all enrolled participants
|
|
Injury, poisoning and procedural complications
Fall
|
6.7%
7/105 • All-cause mortality was collected up to approximately 79 months (end of study) and treatment emergent non-serious adverse events and serious adverse events were collected up to 70 months (end of treatment).
Safety Population included all participants who received any amount of study treatment (i.e. any amount of bevacizumab or niraparib during the study). All-cause mortality was reported for all enrolled participants
|
|
Reproductive system and breast disorders
Pelvic pain
|
5.7%
6/105 • All-cause mortality was collected up to approximately 79 months (end of study) and treatment emergent non-serious adverse events and serious adverse events were collected up to 70 months (end of treatment).
Safety Population included all participants who received any amount of study treatment (i.e. any amount of bevacizumab or niraparib during the study). All-cause mortality was reported for all enrolled participants
|
|
Eye disorders
Vision blurred
|
7.6%
8/105 • All-cause mortality was collected up to approximately 79 months (end of study) and treatment emergent non-serious adverse events and serious adverse events were collected up to 70 months (end of treatment).
Safety Population included all participants who received any amount of study treatment (i.e. any amount of bevacizumab or niraparib during the study). All-cause mortality was reported for all enrolled participants
|
|
Ear and labyrinth disorders
Tinnitus
|
5.7%
6/105 • All-cause mortality was collected up to approximately 79 months (end of study) and treatment emergent non-serious adverse events and serious adverse events were collected up to 70 months (end of treatment).
Safety Population included all participants who received any amount of study treatment (i.e. any amount of bevacizumab or niraparib during the study). All-cause mortality was reported for all enrolled participants
|
|
Immune system disorders
Immune system disorders
|
10.5%
11/105 • All-cause mortality was collected up to approximately 79 months (end of study) and treatment emergent non-serious adverse events and serious adverse events were collected up to 70 months (end of treatment).
Safety Population included all participants who received any amount of study treatment (i.e. any amount of bevacizumab or niraparib during the study). All-cause mortality was reported for all enrolled participants
|
|
Endocrine disorders
Endocrine disorders
|
5.7%
6/105 • All-cause mortality was collected up to approximately 79 months (end of study) and treatment emergent non-serious adverse events and serious adverse events were collected up to 70 months (end of treatment).
Safety Population included all participants who received any amount of study treatment (i.e. any amount of bevacizumab or niraparib during the study). All-cause mortality was reported for all enrolled participants
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
|
9.5%
10/105 • All-cause mortality was collected up to approximately 79 months (end of study) and treatment emergent non-serious adverse events and serious adverse events were collected up to 70 months (end of treatment).
Safety Population included all participants who received any amount of study treatment (i.e. any amount of bevacizumab or niraparib during the study). All-cause mortality was reported for all enrolled participants
|
|
Gastrointestinal disorders
Mouth ulceration
|
6.7%
7/105 • All-cause mortality was collected up to approximately 79 months (end of study) and treatment emergent non-serious adverse events and serious adverse events were collected up to 70 months (end of treatment).
Safety Population included all participants who received any amount of study treatment (i.e. any amount of bevacizumab or niraparib during the study). All-cause mortality was reported for all enrolled participants
|
|
Investigations
Blood alkaline phosphatase increased
|
7.6%
8/105 • All-cause mortality was collected up to approximately 79 months (end of study) and treatment emergent non-serious adverse events and serious adverse events were collected up to 70 months (end of treatment).
Safety Population included all participants who received any amount of study treatment (i.e. any amount of bevacizumab or niraparib during the study). All-cause mortality was reported for all enrolled participants
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
5.7%
6/105 • All-cause mortality was collected up to approximately 79 months (end of study) and treatment emergent non-serious adverse events and serious adverse events were collected up to 70 months (end of treatment).
Safety Population included all participants who received any amount of study treatment (i.e. any amount of bevacizumab or niraparib during the study). All-cause mortality was reported for all enrolled participants
|
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