Trial Outcomes & Findings for A Phase II Study Of Nivolumab/ Bevacizumab/Rucaparib (NCT NCT02873962)

Last Updated: 2026-04-01

Results Overview

The objective response rate was determined by the frequency of patients who had objective tumor response, determined per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by CT or MRI, where objective response represents either a confirmed complete response (CR; disappearance of all target lesions) or a confirmed partial response (PR; at least a 30% decrease in the sum of the longest diameter of target lesions, taking as reference the baseline sum diameters); objective response = CR + PR. The ORR is therefore reported as the percentage of participants who achieved a CR or PR per RECIST v1.1.

Recruitment status

ACTIVE_NOT_RECRUITING

Study phase

PHASE2

Target enrollment

72 participants

Primary outcome timeframe

2 years

Results posted on

2026-04-01

Participant Flow

Participant milestones

Participant milestones
Measure	Cohort 1: Nivolumab With Bevacizumab Participants received Nivolumab and Bevacizumab intravenously on day 1 of each 14-day cycle. Nivolumab: 240 mg IV over 30 minutes -No dose reductions or escalations allowed for Nivolumab Bevacizumab: 10 mg/kg IV over 30 minutes (30 minutes after conclusion of Nivolumab infusion) -One dose reduction allowed for Bevacizumab (5 mg/kg)	Cohort 2: Nivolumab With Bevacizumab and Rucaparib Participants received Nivolumab and Bevacizumab intravenously on on day 1 and Rucaparib orally twice daily on days 1-14 of each 14-day cycle. Nivolumab: 240 mg IV over 30 minutes -No dose reductions or escalations allowed for Nivolumab Bevacizumab: 10 mg/kg IV over 30 minutes (30 minutes after conclusion of Nivolumab infusion) -One dose reduction allowed for Bevacizumab (5 mg/kg) Rucaparib: 600 mg orally twice daily on days 1-14 -Up to three dose reductions allowed for Rucaparib (500 mg twice daily, 400 mg twice daily, and 300 mg twice daily)	Cohort 3: Nivolumab With Bevacizumab and Rucaparib Participants received Nivolumab and Bevacizumab intravenously on on day 1 and Rucaparib orally twice daily on days 1-14 of each 14-day cycle. Nivolumab: 240 mg IV over 30 minutes -No dose reductions or escalations allowed for Nivolumab Bevacizumab: 10 mg/kg IV over 30 minutes (30 minutes after conclusion of Nivolumab infusion) -One dose reduction allowed for Bevacizumab (5 mg/kg) Rucaparib: 300 mg orally twice daily on days 1-14 -Dose escalation and reductions allowed for Rucaparib (400 mg twice daily, 250 mg twice daily, and 200 mg twice daily)
Overall Study STARTED	38	22	12
Overall Study COMPLETED	38	22	12
Overall Study NOT COMPLETED	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

A Phase II Study Of Nivolumab/ Bevacizumab/Rucaparib

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Cohort 1: Nivolumab With Bevacizumab n=38 Participants Participants received Nivolumab and Bevacizumab intravenously on day 1 of each 14-day cycle. Nivolumab: 240 mg IV over 30 minutes -No dose reductions or escalations allowed for Nivolumab Bevacizumab: 10 mg/kg IV over 30 minutes (30 minutes after conclusion of Nivolumab infusion) -One dose reduction allowed for Bevacizumab (5 mg/kg)	Cohort 2: Nivolumab With Bevacizumab and Rucaparib n=22 Participants Participants received Nivolumab and Bevacizumab intravenously on on day 1 and Rucaparib orally twice daily on days 1-14 of each 14-day cycle. Nivolumab: 240 mg IV over 30 minutes -No dose reductions or escalations allowed for Nivolumab Bevacizumab: 10 mg/kg IV over 30 minutes (30 minutes after conclusion of Nivolumab infusion) -One dose reduction allowed for Bevacizumab (5 mg/kg) Rucaparib: 600 mg orally twice daily on days 1-14 -Up to three dose reductions allowed for Rucaparib (500 mg twice daily, 400 mg twice daily, and 300 mg twice daily)	Cohort 3: Nivolumab With Bevacizumab and Rucaparib n=12 Participants Participants received Nivolumab and Bevacizumab intravenously on on day 1 and Rucaparib orally twice daily on days 1-14 of each 14-day cycle. Nivolumab: 240 mg IV over 30 minutes -No dose reductions or escalations allowed for Nivolumab Bevacizumab: 10 mg/kg IV over 30 minutes (30 minutes after conclusion of Nivolumab infusion) -One dose reduction allowed for Bevacizumab (5 mg/kg) Rucaparib: 300 mg orally twice daily on days 1-14 -Dose escalation and reductions allowed for Rucaparib (400 mg twice daily, 250 mg twice daily, and 200 mg twice daily)	Total n=72 Participants Total of all reporting groups
Age, Continuous	63.0 years STANDARD_DEVIATION 9.1 • n=5 Participants	65.6 years STANDARD_DEVIATION 11.2 • n=5 Participants	58.2 years STANDARD_DEVIATION 12.0 • n=10 Participants	62.9 years STANDARD_DEVIATION 10.4 • n=16 Participants
Sex: Female, Male Female	38 Participants n=5 Participants	22 Participants n=5 Participants	12 Participants n=10 Participants	72 Participants n=16 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=5 Participants	0 Participants n=10 Participants	0 Participants n=16 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=5 Participants	0 Participants n=10 Participants	0 Participants n=16 Participants
Race (NIH/OMB) Asian	2 Participants n=5 Participants	0 Participants n=5 Participants	2 Participants n=10 Participants	4 Participants n=16 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=5 Participants	0 Participants n=10 Participants	0 Participants n=16 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	0 Participants n=5 Participants	1 Participants n=10 Participants	1 Participants n=16 Participants
Race (NIH/OMB) White	35 Participants n=5 Participants	20 Participants n=5 Participants	8 Participants n=10 Participants	63 Participants n=16 Participants
Race (NIH/OMB) More than one race	1 Participants n=5 Participants	0 Participants n=5 Participants	0 Participants n=10 Participants	1 Participants n=16 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	2 Participants n=5 Participants	1 Participants n=10 Participants	3 Participants n=16 Participants
ECOG Performance Status 00 - Fully active	22 Participants n=5 Participants	11 Participants n=5 Participants	7 Participants n=10 Participants	40 Participants n=16 Participants
ECOG Performance Status 01 - Restricted	16 Participants n=5 Participants	11 Participants n=5 Participants	5 Participants n=10 Participants	32 Participants n=16 Participants
Number of Prior Lines of Treatment 1	16 Participants n=5 Participants	11 Participants n=5 Participants	6 Participants n=10 Participants	33 Participants n=16 Participants
Number of Prior Lines of Treatment 2	13 Participants n=5 Participants	4 Participants n=5 Participants	3 Participants n=10 Participants	20 Participants n=16 Participants
Number of Prior Lines of Treatment 3	9 Participants n=5 Participants	7 Participants n=5 Participants	3 Participants n=10 Participants	19 Participants n=16 Participants
Histologic Subtype Adenocarcinoma	10 Participants n=5 Participants	2 Participants n=5 Participants	0 Participants n=10 Participants	12 Participants n=16 Participants
Histologic Subtype Carcinosarcoma	2 Participants n=5 Participants	0 Participants n=5 Participants	0 Participants n=10 Participants	2 Participants n=16 Participants
Histologic Subtype Clear Cell	2 Participants n=5 Participants	2 Participants n=5 Participants	1 Participants n=10 Participants	5 Participants n=16 Participants
Histologic Subtype Endometrioid	0 Participants n=5 Participants	1 Participants n=5 Participants	1 Participants n=10 Participants	2 Participants n=16 Participants
Histologic Subtype Mixed	1 Participants n=5 Participants	0 Participants n=5 Participants	0 Participants n=10 Participants	1 Participants n=16 Participants
Histologic Subtype Serous	23 Participants n=5 Participants	16 Participants n=5 Participants	10 Participants n=10 Participants	49 Participants n=16 Participants
Histologic Subtype Serous and Endometrioid	0 Participants n=5 Participants	1 Participants n=5 Participants	0 Participants n=10 Participants	1 Participants n=16 Participants
Platinum Status Platinum Resistant	18 Participants n=5 Participants	11 Participants n=5 Participants	0 Participants n=10 Participants	29 Participants n=16 Participants
Platinum Status Platinum Sensitive	20 Participants n=5 Participants	11 Participants n=5 Participants	12 Participants n=10 Participants	43 Participants n=16 Participants

PRIMARY outcome

Timeframe: 18 months

Outcome measures

Outcome measures
Measure	Cohort 1: Nivolumab and Bevacizumab n=38 Participants Participants received Nivolumab and Bevacizumab intravenously on day 1 of each 14-day cycle. Nivolumab: 240 mg IV over 30 minutes -No dose reductions or escalations allowed for Nivolumab Bevacizumab: 10 mg/kg IV over 30 minutes (30 minutes after conclusion of Nivolumab infusion) -One dose reduction allowed for Bevacizumab (5 mg/kg)
Cohort 1: Objective Response Rate	11 Participants

PRIMARY outcome

Timeframe: 2 years

Outcome measures

Outcome measures
Measure	Cohort 1: Nivolumab and Bevacizumab n=22 Participants Participants received Nivolumab and Bevacizumab intravenously on day 1 of each 14-day cycle. Nivolumab: 240 mg IV over 30 minutes -No dose reductions or escalations allowed for Nivolumab Bevacizumab: 10 mg/kg IV over 30 minutes (30 minutes after conclusion of Nivolumab infusion) -One dose reduction allowed for Bevacizumab (5 mg/kg)
Cohort 2: Objective Response Rate	3 Participants

PRIMARY outcome

Timeframe: 100 days

Tolerability of the combination of nivolumab, bevacizumab, and rucaparib for cohort 3 was determined by the number of patients who maintained dosing without drug modifications (including dose holds and reductions) within the first 100 days of dosing.

Outcome measures

Outcome measures
Measure	Cohort 1: Nivolumab and Bevacizumab n=12 Participants Participants received Nivolumab and Bevacizumab intravenously on day 1 of each 14-day cycle. Nivolumab: 240 mg IV over 30 minutes -No dose reductions or escalations allowed for Nivolumab Bevacizumab: 10 mg/kg IV over 30 minutes (30 minutes after conclusion of Nivolumab infusion) -One dose reduction allowed for Bevacizumab (5 mg/kg)
Cohort 3: Tolerability	1 Participants

SECONDARY outcome

Timeframe: 6 months

Other events: 22 other events

Deaths: 5 deaths

Cohort 3: Nivolumab With Bevacizumab and Rucaparib

Serious events: 6 serious events

Other events: 12 other events

Deaths: 0 deaths

Serious adverse events

Other adverse events

Additional Information

Joyce Liu, MD MPH

Dana-Farber Cancer Institute

Phone: 617-632-5269

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Measure	Cohort 1: Nivolumab With Bevacizumab n=38 participants at risk Participants received Nivolumab and Bevacizumab intravenously on day 1 of each 14-day cycle. Nivolumab: 240 mg IV over 30 minutes -No dose reductions or escalations allowed for Nivolumab Bevacizumab: 10 mg/kg IV over 30 minutes (30 minutes after conclusion of Nivolumab infusion) -One dose reduction allowed for Bevacizumab (5 mg/kg)	Cohort 2: Nivolumab With Bevacizumab and Rucaparib n=22 participants at risk Participants received Nivolumab and Bevacizumab intravenously on on day 1 and Rucaparib orally twice daily on days 1-14 of each 14-day cycle. Nivolumab: 240 mg IV over 30 minutes * No dose reductions or escalations allowed for Nivolumab Bevacizumab: 10 mg/kg IV over 30 minutes (30 minutes after conclusion of Nivolumab infusion) -One dose reduction allowed for Bevacizumab (5 mg/kg) Rucaparib: 600 mg orally twice daily on days 1-14 * Up to three dose reductions allowed for Rucaparib (500 mg twice daily, 400 mg twice daily, and 300 mg twice daily)	Cohort 3: Nivolumab With Bevacizumab and Rucaparib n=12 participants at risk Participants received Nivolumab and Bevacizumab intravenously on on day 1 and Rucaparib orally twice daily on days 1-14 of each 14-day cycle. Nivolumab: 240 mg IV over 30 minutes * No dose reductions or escalations allowed for Nivolumab Bevacizumab: 10 mg/kg IV over 30 minutes (30 minutes after conclusion of Nivolumab infusion) -One dose reduction allowed for Bevacizumab (5 mg/kg) Rucaparib: 300 mg orally twice daily on days 1-14 * Dose escalation and reductions allowed for Rucaparib (400 mg twice daily, 250 mg twice daily, and 200 mg twice daily)
Blood and lymphatic system disorders Anemia	0.00% 0/38 • Adverse event data was collected for all participants through 100 days after receipt of last dose of study drug (up to 5 years).	13.6% 3/22 • Adverse event data was collected for all participants through 100 days after receipt of last dose of study drug (up to 5 years).	0.00% 0/12 • Adverse event data was collected for all participants through 100 days after receipt of last dose of study drug (up to 5 years).
Cardiac disorders Myocardial infarction	0.00% 0/38 • Adverse event data was collected for all participants through 100 days after receipt of last dose of study drug (up to 5 years).	4.5% 1/22 • Adverse event data was collected for all participants through 100 days after receipt of last dose of study drug (up to 5 years).	0.00% 0/12 • Adverse event data was collected for all participants through 100 days after receipt of last dose of study drug (up to 5 years).
Eye disorders Eye disorders - Other, specify	0.00% 0/38 • Adverse event data was collected for all participants through 100 days after receipt of last dose of study drug (up to 5 years).	4.5% 1/22 • Adverse event data was collected for all participants through 100 days after receipt of last dose of study drug (up to 5 years).	0.00% 0/12 • Adverse event data was collected for all participants through 100 days after receipt of last dose of study drug (up to 5 years).
Gastrointestinal disorders Colitis	0.00% 0/38 • Adverse event data was collected for all participants through 100 days after receipt of last dose of study drug (up to 5 years).	4.5% 1/22 • Adverse event data was collected for all participants through 100 days after receipt of last dose of study drug (up to 5 years).	0.00% 0/12 • Adverse event data was collected for all participants through 100 days after receipt of last dose of study drug (up to 5 years).
Gastrointestinal disorders Colonic fistula	2.6% 1/38 • Adverse event data was collected for all participants through 100 days after receipt of last dose of study drug (up to 5 years).	0.00% 0/22 • Adverse event data was collected for all participants through 100 days after receipt of last dose of study drug (up to 5 years).	0.00% 0/12 • Adverse event data was collected for all participants through 100 days after receipt of last dose of study drug (up to 5 years).
Gastrointestinal disorders Diarrhea	0.00% 0/38 • Adverse event data was collected for all participants through 100 days after receipt of last dose of study drug (up to 5 years).	13.6% 3/22 • Adverse event data was collected for all participants through 100 days after receipt of last dose of study drug (up to 5 years).	16.7% 2/12 • Adverse event data was collected for all participants through 100 days after receipt of last dose of study drug (up to 5 years).
Gastrointestinal disorders Duodenal perforation	2.6% 1/38 • Adverse event data was collected for all participants through 100 days after receipt of last dose of study drug (up to 5 years).	0.00% 0/22 • Adverse event data was collected for all participants through 100 days after receipt of last dose of study drug (up to 5 years).	0.00% 0/12 • Adverse event data was collected for all participants through 100 days after receipt of last dose of study drug (up to 5 years).
Gastrointestinal disorders Mucositis oral	0.00% 0/38 • Adverse event data was collected for all participants through 100 days after receipt of last dose of study drug (up to 5 years).	0.00% 0/22 • Adverse event data was collected for all participants through 100 days after receipt of last dose of study drug (up to 5 years).	8.3% 1/12 • Adverse event data was collected for all participants through 100 days after receipt of last dose of study drug (up to 5 years).
Gastrointestinal disorders Pancreatitis	0.00% 0/38 • Adverse event data was collected for all participants through 100 days after receipt of last dose of study drug (up to 5 years).	0.00% 0/22 • Adverse event data was collected for all participants through 100 days after receipt of last dose of study drug (up to 5 years).	8.3% 1/12 • Adverse event data was collected for all participants through 100 days after receipt of last dose of study drug (up to 5 years).
General disorders Fatigue	0.00% 0/38 • Adverse event data was collected for all participants through 100 days after receipt of last dose of study drug (up to 5 years).	31.8% 7/22 • Adverse event data was collected for all participants through 100 days after receipt of last dose of study drug (up to 5 years).	25.0% 3/12 • Adverse event data was collected for all participants through 100 days after receipt of last dose of study drug (up to 5 years).
General disorders Fever	2.6% 1/38 • Adverse event data was collected for all participants through 100 days after receipt of last dose of study drug (up to 5 years).	0.00% 0/22 • Adverse event data was collected for all participants through 100 days after receipt of last dose of study drug (up to 5 years).	0.00% 0/12 • Adverse event data was collected for all participants through 100 days after receipt of last dose of study drug (up to 5 years).
General disorders General disorders and administration site conditions - Other, specify	2.6% 1/38 • Adverse event data was collected for all participants through 100 days after receipt of last dose of study drug (up to 5 years).	0.00% 0/22 • Adverse event data was collected for all participants through 100 days after receipt of last dose of study drug (up to 5 years).	0.00% 0/12 • Adverse event data was collected for all participants through 100 days after receipt of last dose of study drug (up to 5 years).
Immune system disorders Autoimmune disorder	0.00% 0/38 • Adverse event data was collected for all participants through 100 days after receipt of last dose of study drug (up to 5 years).	4.5% 1/22 • Adverse event data was collected for all participants through 100 days after receipt of last dose of study drug (up to 5 years).	0.00% 0/12 • Adverse event data was collected for all participants through 100 days after receipt of last dose of study drug (up to 5 years).
Infections and infestations Encephalitis infection	2.6% 1/38 • Adverse event data was collected for all participants through 100 days after receipt of last dose of study drug (up to 5 years).	0.00% 0/22 • Adverse event data was collected for all participants through 100 days after receipt of last dose of study drug (up to 5 years).	0.00% 0/12 • Adverse event data was collected for all participants through 100 days after receipt of last dose of study drug (up to 5 years).
Infections and infestations Infections and infestations - Other, specify	2.6% 1/38 • Adverse event data was collected for all participants through 100 days after receipt of last dose of study drug (up to 5 years).	0.00% 0/22 • Adverse event data was collected for all participants through 100 days after receipt of last dose of study drug (up to 5 years).	0.00% 0/12 • Adverse event data was collected for all participants through 100 days after receipt of last dose of study drug (up to 5 years).
Injury, poisoning and procedural complications Wound complication	2.6% 1/38 • Adverse event data was collected for all participants through 100 days after receipt of last dose of study drug (up to 5 years).	0.00% 0/22 • Adverse event data was collected for all participants through 100 days after receipt of last dose of study drug (up to 5 years).	0.00% 0/12 • Adverse event data was collected for all participants through 100 days after receipt of last dose of study drug (up to 5 years).
Investigations Alanine aminotransferase increased	2.6% 1/38 • Adverse event data was collected for all participants through 100 days after receipt of last dose of study drug (up to 5 years).	36.4% 8/22 • Adverse event data was collected for all participants through 100 days after receipt of last dose of study drug (up to 5 years).	16.7% 2/12 • Adverse event data was collected for all participants through 100 days after receipt of last dose of study drug (up to 5 years).
Investigations Aspartate aminotransferase increased	2.6% 1/38 • Adverse event data was collected for all participants through 100 days after receipt of last dose of study drug (up to 5 years).	27.3% 6/22 • Adverse event data was collected for all participants through 100 days after receipt of last dose of study drug (up to 5 years).	16.7% 2/12 • Adverse event data was collected for all participants through 100 days after receipt of last dose of study drug (up to 5 years).
Investigations Lipase increased	10.5% 4/38 • Adverse event data was collected for all participants through 100 days after receipt of last dose of study drug (up to 5 years).	4.5% 1/22 • Adverse event data was collected for all participants through 100 days after receipt of last dose of study drug (up to 5 years).	33.3% 4/12 • Adverse event data was collected for all participants through 100 days after receipt of last dose of study drug (up to 5 years).
Investigations Lymphocyte count decreased	0.00% 0/38 • Adverse event data was collected for all participants through 100 days after receipt of last dose of study drug (up to 5 years).	0.00% 0/22 • Adverse event data was collected for all participants through 100 days after receipt of last dose of study drug (up to 5 years).	8.3% 1/12 • Adverse event data was collected for all participants through 100 days after receipt of last dose of study drug (up to 5 years).
Investigations Neutrophil count decreased	0.00% 0/38 • Adverse event data was collected for all participants through 100 days after receipt of last dose of study drug (up to 5 years).	4.5% 1/22 • Adverse event data was collected for all participants through 100 days after receipt of last dose of study drug (up to 5 years).	0.00% 0/12 • Adverse event data was collected for all participants through 100 days after receipt of last dose of study drug (up to 5 years).
Investigations Serum amylase increased	7.9% 3/38 • Adverse event data was collected for all participants through 100 days after receipt of last dose of study drug (up to 5 years).	0.00% 0/22 • Adverse event data was collected for all participants through 100 days after receipt of last dose of study drug (up to 5 years).	8.3% 1/12 • Adverse event data was collected for all participants through 100 days after receipt of last dose of study drug (up to 5 years).
Metabolism and nutrition disorders Hypokalemia	0.00% 0/38 • Adverse event data was collected for all participants through 100 days after receipt of last dose of study drug (up to 5 years).	4.5% 1/22 • Adverse event data was collected for all participants through 100 days after receipt of last dose of study drug (up to 5 years).	0.00% 0/12 • Adverse event data was collected for all participants through 100 days after receipt of last dose of study drug (up to 5 years).
Metabolism and nutrition disorders Hyponatremia	2.6% 1/38 • Adverse event data was collected for all participants through 100 days after receipt of last dose of study drug (up to 5 years).	4.5% 1/22 • Adverse event data was collected for all participants through 100 days after receipt of last dose of study drug (up to 5 years).	0.00% 0/12 • Adverse event data was collected for all participants through 100 days after receipt of last dose of study drug (up to 5 years).
Musculoskeletal and connective tissue disorders Arthralgia	2.6% 1/38 • Adverse event data was collected for all participants through 100 days after receipt of last dose of study drug (up to 5 years).	0.00% 0/22 • Adverse event data was collected for all participants through 100 days after receipt of last dose of study drug (up to 5 years).	0.00% 0/12 • Adverse event data was collected for all participants through 100 days after receipt of last dose of study drug (up to 5 years).
Musculoskeletal and connective tissue disorders Myalgia	2.6% 1/38 • Adverse event data was collected for all participants through 100 days after receipt of last dose of study drug (up to 5 years).	0.00% 0/22 • Adverse event data was collected for all participants through 100 days after receipt of last dose of study drug (up to 5 years).	0.00% 0/12 • Adverse event data was collected for all participants through 100 days after receipt of last dose of study drug (up to 5 years).
Musculoskeletal and connective tissue disorders Myositis	0.00% 0/38 • Adverse event data was collected for all participants through 100 days after receipt of last dose of study drug (up to 5 years).	4.5% 1/22 • Adverse event data was collected for all participants through 100 days after receipt of last dose of study drug (up to 5 years).	0.00% 0/12 • Adverse event data was collected for all participants through 100 days after receipt of last dose of study drug (up to 5 years).
Musculoskeletal and connective tissue disorders Osteonecrosis of jaw	0.00% 0/38 • Adverse event data was collected for all participants through 100 days after receipt of last dose of study drug (up to 5 years).	0.00% 0/22 • Adverse event data was collected for all participants through 100 days after receipt of last dose of study drug (up to 5 years).	8.3% 1/12 • Adverse event data was collected for all participants through 100 days after receipt of last dose of study drug (up to 5 years).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Myelodysplastic syndrome	0.00% 0/38 • Adverse event data was collected for all participants through 100 days after receipt of last dose of study drug (up to 5 years).	4.5% 1/22 • Adverse event data was collected for all participants through 100 days after receipt of last dose of study drug (up to 5 years).	0.00% 0/12 • Adverse event data was collected for all participants through 100 days after receipt of last dose of study drug (up to 5 years).
Nervous system disorders Nervous system disorders - Other, specify	0.00% 0/38 • Adverse event data was collected for all participants through 100 days after receipt of last dose of study drug (up to 5 years).	4.5% 1/22 • Adverse event data was collected for all participants through 100 days after receipt of last dose of study drug (up to 5 years).	0.00% 0/12 • Adverse event data was collected for all participants through 100 days after receipt of last dose of study drug (up to 5 years).
Nervous system disorders Seizure	2.6% 1/38 • Adverse event data was collected for all participants through 100 days after receipt of last dose of study drug (up to 5 years).	0.00% 0/22 • Adverse event data was collected for all participants through 100 days after receipt of last dose of study drug (up to 5 years).	0.00% 0/12 • Adverse event data was collected for all participants through 100 days after receipt of last dose of study drug (up to 5 years).
Psychiatric disorders Psychiatric disorders - Other, specify	2.6% 1/38 • Adverse event data was collected for all participants through 100 days after receipt of last dose of study drug (up to 5 years).	0.00% 0/22 • Adverse event data was collected for all participants through 100 days after receipt of last dose of study drug (up to 5 years).	0.00% 0/12 • Adverse event data was collected for all participants through 100 days after receipt of last dose of study drug (up to 5 years).
Renal and urinary disorders Renal and urinary disorders - Other, specify	2.6% 1/38 • Adverse event data was collected for all participants through 100 days after receipt of last dose of study drug (up to 5 years).	0.00% 0/22 • Adverse event data was collected for all participants through 100 days after receipt of last dose of study drug (up to 5 years).	0.00% 0/12 • Adverse event data was collected for all participants through 100 days after receipt of last dose of study drug (up to 5 years).
Respiratory, thoracic and mediastinal disorders Hoarseness	0.00% 0/38 • Adverse event data was collected for all participants through 100 days after receipt of last dose of study drug (up to 5 years).	0.00% 0/22 • Adverse event data was collected for all participants through 100 days after receipt of last dose of study drug (up to 5 years).	8.3% 1/12 • Adverse event data was collected for all participants through 100 days after receipt of last dose of study drug (up to 5 years).
Respiratory, thoracic and mediastinal disorders Respiratory, thoracic and mediastinal disorders	0.00% 0/38 • Adverse event data was collected for all participants through 100 days after receipt of last dose of study drug (up to 5 years).	4.5% 1/22 • Adverse event data was collected for all participants through 100 days after receipt of last dose of study drug (up to 5 years).	0.00% 0/12 • Adverse event data was collected for all participants through 100 days after receipt of last dose of study drug (up to 5 years).
Skin and subcutaneous tissue disorders Rash maculo-papular	2.6% 1/38 • Adverse event data was collected for all participants through 100 days after receipt of last dose of study drug (up to 5 years).	9.1% 2/22 • Adverse event data was collected for all participants through 100 days after receipt of last dose of study drug (up to 5 years).	25.0% 3/12 • Adverse event data was collected for all participants through 100 days after receipt of last dose of study drug (up to 5 years).
Vascular disorders Hypertension	7.9% 3/38 • Adverse event data was collected for all participants through 100 days after receipt of last dose of study drug (up to 5 years).	0.00% 0/22 • Adverse event data was collected for all participants through 100 days after receipt of last dose of study drug (up to 5 years).	8.3% 1/12 • Adverse event data was collected for all participants through 100 days after receipt of last dose of study drug (up to 5 years).
Vascular disorders Thromboembolic event	2.6% 1/38 • Adverse event data was collected for all participants through 100 days after receipt of last dose of study drug (up to 5 years).	0.00% 0/22 • Adverse event data was collected for all participants through 100 days after receipt of last dose of study drug (up to 5 years).	0.00% 0/12 • Adverse event data was collected for all participants through 100 days after receipt of last dose of study drug (up to 5 years).