Trial Outcomes & Findings for Phase 3 Study of Rucaparib as Switch Maintenance After Platinum in Relapsed High Grade Serous or Endometrioid Ovarian Cancer (ARIEL3) (NCT NCT01968213)

NCT ID: NCT01968213

Last Updated: 2023-06-09

Results Overview

Progression-free survival by Investigator (invPFS) is defined as the time from randomization to disease progression, according to RECIST v1.1 criteria as assessed by the investigator, or death due to any cause, whichever occurs first. Progressive disease is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), as a 20% increase in the sum of the longest diameter of measurable lesions, an unequivocal increase in existing non-measurable lesion(s), or the appearance of unequivocal new lesion(s).

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 564 participants
• Primary outcome timeframe: Every 12 calendar weeks (within 7 days prior is permitted) after start of treatment until treatment discontinuation due to disease progression. Total follow-up was up to approximately 3 years.
• Results posted on: 2023-06-09

Participant Flow

564 subjects were recruited from 87 sites across 11 countries and randomized (2:1) to treatment with rucaparib or placebo

Participant milestones

Measure	Rucaparib 600 mg Tablets Taken orally twice daily (continuous 28 day treatment cycles)	Placebo Tablets Taken orally twice daily (continuous 28 day treatment cycles)
Overall Study STARTED	375	189
Overall Study COMPLETED	375	189
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Phase 3 Study of Rucaparib as Switch Maintenance After Platinum in Relapsed High Grade Serous or Endometrioid Ovarian Cancer (ARIEL3)

Baseline characteristics by cohort

Measure	Rucaparib 600 mg Tablets n=375 Participants Taken orally twice daily (continuous 28 day treatment cycles)	Placebo Tablets n=189 Participants Taken orally twice daily (continuous 28 day treatment cycles)	Total n=564 Participants Total of all reporting groups
Age, Continuous	61 Years n=5 Participants	62 Years n=7 Participants	61 Years n=5 Participants
Sex: Female, Male Female	375 Participants n=5 Participants	189 Participants n=7 Participants	564 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	3 Participants n=5 Participants	1 Participants n=7 Participants	4 Participants n=5 Participants
Race (NIH/OMB) Asian	14 Participants n=5 Participants	7 Participants n=7 Participants	21 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	6 Participants n=5 Participants	2 Participants n=7 Participants	8 Participants n=5 Participants
Race (NIH/OMB) White	292 Participants n=5 Participants	144 Participants n=7 Participants	436 Participants n=5 Participants
Race (NIH/OMB) More than one race	12 Participants n=5 Participants	8 Participants n=7 Participants	20 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	48 Participants n=5 Participants	27 Participants n=7 Participants	75 Participants n=5 Participants
Best Response from Previous Platinum Therapy RECIST CR	126 Participants n=5 Participants	64 Participants n=7 Participants	190 Participants n=5 Participants
Best Response from Previous Platinum Therapy RECIST / CA-125 PR	249 Participants n=5 Participants	125 Participants n=7 Participants	374 Participants n=5 Participants
Penultimate Progression-free (PF) Interval 6-12 Months	151 Participants n=5 Participants	76 Participants n=7 Participants	227 Participants n=5 Participants
Penultimate Progression-free (PF) Interval >12 Months	224 Participants n=5 Participants	113 Participants n=7 Participants	337 Participants n=5 Participants
Bulky Lesions (lesion >20 mm) at Baseline Yes	71 Participants n=5 Participants	29 Participants n=7 Participants	100 Participants n=5 Participants
Bulky Lesions (lesion >20 mm) at Baseline No	304 Participants n=5 Participants	160 Participants n=7 Participants	464 Participants n=5 Participants

PRIMARY outcome

Timeframe: Every 12 calendar weeks (within 7 days prior is permitted) after start of treatment until treatment discontinuation due to disease progression. Total follow-up was up to approximately 3 years.

Population: Intent-to-treat: All patients randomized

Progression-free survival by Investigator (invPFS) is defined as the time from randomization to disease progression, according to RECIST v1.1 criteria as assessed by the investigator, or death due to any cause, whichever occurs first. Progressive disease is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), as a 20% increase in the sum of the longest diameter of measurable lesions, an unequivocal increase in existing non-measurable lesion(s), or the appearance of unequivocal new lesion(s).

Outcome measures

Measure	Rucaparib 600 mg Tablets n=375 Participants Taken orally twice daily (continuous 28 day treatment cycles)	Placebo Tablets n=189 Participants Taken orally twice daily (continuous 28 day treatment cycles)
Disease Progression According to RECIST Version 1.1, as Assessed by the Investigator, or Death From Any Cause (Investigator Progression Free Survival as Per invPFS)	10.8 Months Interval 8.3 to 11.4	5.4 Months Interval 5.3 to 5.5

SECONDARY outcome

Timeframe: Every 12 calendar weeks (within 7 days prior is permitted) after start of treatment until treatment discontinuation due to disease progression. Total follow-up was up to approximately 8.2 years.

Population: Intent-to-treat: All patients randomized

To evaluate PFS by RECIST v1.1, as assessed by independent radiology review (IRR).

Outcome measures

Measure	Rucaparib 600 mg Tablets n=375 Participants Taken orally twice daily (continuous 28 day treatment cycles)	Placebo Tablets n=189 Participants Taken orally twice daily (continuous 28 day treatment cycles)
Disease Progression According to RECIST v1.1, as Assessed by Independent Radiology Review (IRR), or Death From Any Cause (irrPFS)	13.7 months Interval 11.0 to 19.1	5.4 months Interval 5.1 to 5.5

SECONDARY outcome

Timeframe: All patients were followed for survival up to approximately 8.2 years.

Population: Intent-to-treat: All patients randomized

Overall survival (OS) is defined as the number of days from the date of randomization to the date of death (due to any cause). Patients who are still alive were censored on the date of their last available visit or last date known to be alive.

Outcome measures

Measure	Rucaparib 600 mg Tablets n=375 Participants Taken orally twice daily (continuous 28 day treatment cycles)	Placebo Tablets n=189 Participants Taken orally twice daily (continuous 28 day treatment cycles)
Overall Survival (OS)	36.0 Months Interval 32.8 to 39.4	43.2 Months Interval 38.1 to 46.9

SECONDARY outcome

Timeframe: Screening, Day 1 of each treatment cycle, Treatment Discontinuation visit, and 28-day Follow-up visit. Total follow-up was up to approximately 6.4 years.

Population: Intent-to-treat: All patients randomized

The National Comprehensive Cancer Network-Functional Assessment of Cancer Therapy (NCCN-FACT) FACT-Ovarian Symptom Index (FOSI-18) is a questionnaire, for completion by patients, designed to assess the impact of cancer therapy on ovarian cancer-related symptoms and is based on numerical point scoring of symptoms. The DRS-P subscale of the questionnaire is specifically designed to assess physical symptoms of ovarian cancer and evaluate changes in the subscale point score in individual assessments over time. This study looked at the time to a 4-point reduction in subscale score as an indicator of improvement in disease-related physical symptoms on cancer therapy.

Outcome measures

Measure	Rucaparib 600 mg Tablets n=375 Participants Taken orally twice daily (continuous 28 day treatment cycles)	Placebo Tablets n=189 Participants Taken orally twice daily (continuous 28 day treatment cycles)
Time to a 4-point Decrease in the Disease-related Symptoms - Physical (DRS-P) Subscale of the FOSI-18	1.9 Months Interval 1.8 to 2.8	6.4 Months Interval 4.6 to 9.2

SECONDARY outcome

Timeframe: Screening, Day 1 of each treatment cycle, Treatment Discontinuation visit, and 28-day Follow-up visit. Total follow-up was up to approximately 6.4 years.

Population: Intent-to-treat: All patients randomized

The National Comprehensive Cancer Network-Functional Assessment of Cancer Therapy (NCCN-FACT) FACT-Ovarian Symptom Index (FOSI-18) is a questionnaire, for completion by patients, designed to assess the impact of cancer therapy on ovarian cancer-related physical, emotional and treatment-related symptoms, and is based on numerical point scoring of symptoms. The questionnaire is designed to evaluate changes in the total score in individual assessments over time. This study looked at the time to an 8-point reduction in the total score as an indicator of improvement in disease-related symptoms on cancer therapy.

Outcome measures

Measure	Rucaparib 600 mg Tablets n=375 Participants Taken orally twice daily (continuous 28 day treatment cycles)	Placebo Tablets n=189 Participants Taken orally twice daily (continuous 28 day treatment cycles)
Time to an 8-point Decrease in the Total Score of the FOSI-18	2.9 Months Interval 2.7 to 3.7	10.8 Months Interval 9.2 to 17.5

SECONDARY outcome

Timeframe: Study data collection occurred over approximately 7 months.

Population: All patients who are treated with rucaparib with at least one pharmacokinetic (PK) measurement

Concentration summary statistics

Outcome measures

Measure	Rucaparib 600 mg Tablets n=295 Participants Taken orally twice daily (continuous 28 day treatment cycles)	Placebo Tablets Taken orally twice daily (continuous 28 day treatment cycles)
Individual Model Parameter Estimates of Rucaparib and Covariates Identification Cycle 2 Day 1	1128 ng/mL Geometric Coefficient of Variation 95.42	—
Individual Model Parameter Estimates of Rucaparib and Covariates Identification Cycle 4 Day 1	1136 ng/mL Geometric Coefficient of Variation 86.19	—
Individual Model Parameter Estimates of Rucaparib and Covariates Identification Cycle 7 Day 1	1165 ng/mL Geometric Coefficient of Variation 78.53	—

Adverse Events

Rucaparib 600 mg Tablets

Serious events: 91 serious events

Other events: 372 other events

Deaths: 9 deaths

Placebo Tablets

Serious events: 20 serious events

Other events: 182 other events

Deaths: 2 deaths

Serious adverse events

Measure	Rucaparib 600 mg Tablets n=372 participants at risk Taken orally twice daily (continuous 28 day treatment cycles)	Placebo Tablets n=189 participants at risk Taken orally twice daily (continuous 28 day treatment cycles)
Blood and lymphatic system disorders Febrile neutropenia	1.3% 5/372 • Adverse events were reported from the date of first dose of study drug and until 28 days after last dose of study drug, approximately 8.2 years. Three patients were randomized to the rucaparib arm and discontinued prior to receiving study drug. Reasons for discontinuation were due to withdrawal of consent, physician decision, and laboratory value (did not meet eligibility criteria)	0.00% 0/189 • Adverse events were reported from the date of first dose of study drug and until 28 days after last dose of study drug, approximately 8.2 years. Three patients were randomized to the rucaparib arm and discontinued prior to receiving study drug. Reasons for discontinuation were due to withdrawal of consent, physician decision, and laboratory value (did not meet eligibility criteria)
Blood and lymphatic system disorders Pancytopenia	0.54% 2/372 • Adverse events were reported from the date of first dose of study drug and until 28 days after last dose of study drug, approximately 8.2 years. Three patients were randomized to the rucaparib arm and discontinued prior to receiving study drug. Reasons for discontinuation were due to withdrawal of consent, physician decision, and laboratory value (did not meet eligibility criteria)	0.00% 0/189 • Adverse events were reported from the date of first dose of study drug and until 28 days after last dose of study drug, approximately 8.2 years. Three patients were randomized to the rucaparib arm and discontinued prior to receiving study drug. Reasons for discontinuation were due to withdrawal of consent, physician decision, and laboratory value (did not meet eligibility criteria)
Cardiac disorders Atrial fibrillation	0.27% 1/372 • Adverse events were reported from the date of first dose of study drug and until 28 days after last dose of study drug, approximately 8.2 years. Three patients were randomized to the rucaparib arm and discontinued prior to receiving study drug. Reasons for discontinuation were due to withdrawal of consent, physician decision, and laboratory value (did not meet eligibility criteria)	0.00% 0/189 • Adverse events were reported from the date of first dose of study drug and until 28 days after last dose of study drug, approximately 8.2 years. Three patients were randomized to the rucaparib arm and discontinued prior to receiving study drug. Reasons for discontinuation were due to withdrawal of consent, physician decision, and laboratory value (did not meet eligibility criteria)
Cardiac disorders Pericardial effusion	0.27% 1/372 • Adverse events were reported from the date of first dose of study drug and until 28 days after last dose of study drug, approximately 8.2 years. Three patients were randomized to the rucaparib arm and discontinued prior to receiving study drug. Reasons for discontinuation were due to withdrawal of consent, physician decision, and laboratory value (did not meet eligibility criteria)	0.00% 0/189 • Adverse events were reported from the date of first dose of study drug and until 28 days after last dose of study drug, approximately 8.2 years. Three patients were randomized to the rucaparib arm and discontinued prior to receiving study drug. Reasons for discontinuation were due to withdrawal of consent, physician decision, and laboratory value (did not meet eligibility criteria)
Cardiac disorders Sinus bradycardia	0.00% 0/372 • Adverse events were reported from the date of first dose of study drug and until 28 days after last dose of study drug, approximately 8.2 years. Three patients were randomized to the rucaparib arm and discontinued prior to receiving study drug. Reasons for discontinuation were due to withdrawal of consent, physician decision, and laboratory value (did not meet eligibility criteria)	0.53% 1/189 • Adverse events were reported from the date of first dose of study drug and until 28 days after last dose of study drug, approximately 8.2 years. Three patients were randomized to the rucaparib arm and discontinued prior to receiving study drug. Reasons for discontinuation were due to withdrawal of consent, physician decision, and laboratory value (did not meet eligibility criteria)
Eye disorders Diplopia	0.27% 1/372 • Adverse events were reported from the date of first dose of study drug and until 28 days after last dose of study drug, approximately 8.2 years. Three patients were randomized to the rucaparib arm and discontinued prior to receiving study drug. Reasons for discontinuation were due to withdrawal of consent, physician decision, and laboratory value (did not meet eligibility criteria)	0.00% 0/189 • Adverse events were reported from the date of first dose of study drug and until 28 days after last dose of study drug, approximately 8.2 years. Three patients were randomized to the rucaparib arm and discontinued prior to receiving study drug. Reasons for discontinuation were due to withdrawal of consent, physician decision, and laboratory value (did not meet eligibility criteria)
Gastrointestinal disorders Abdominal hernia	0.27% 1/372 • Adverse events were reported from the date of first dose of study drug and until 28 days after last dose of study drug, approximately 8.2 years. Three patients were randomized to the rucaparib arm and discontinued prior to receiving study drug. Reasons for discontinuation were due to withdrawal of consent, physician decision, and laboratory value (did not meet eligibility criteria)	0.00% 0/189 • Adverse events were reported from the date of first dose of study drug and until 28 days after last dose of study drug, approximately 8.2 years. Three patients were randomized to the rucaparib arm and discontinued prior to receiving study drug. Reasons for discontinuation were due to withdrawal of consent, physician decision, and laboratory value (did not meet eligibility criteria)
Gastrointestinal disorders Abdominal pain	1.6% 6/372 • Adverse events were reported from the date of first dose of study drug and until 28 days after last dose of study drug, approximately 8.2 years. Three patients were randomized to the rucaparib arm and discontinued prior to receiving study drug. Reasons for discontinuation were due to withdrawal of consent, physician decision, and laboratory value (did not meet eligibility criteria)	0.00% 0/189 • Adverse events were reported from the date of first dose of study drug and until 28 days after last dose of study drug, approximately 8.2 years. Three patients were randomized to the rucaparib arm and discontinued prior to receiving study drug. Reasons for discontinuation were due to withdrawal of consent, physician decision, and laboratory value (did not meet eligibility criteria)
Gastrointestinal disorders Constipation	1.3% 5/372 • Adverse events were reported from the date of first dose of study drug and until 28 days after last dose of study drug, approximately 8.2 years. Three patients were randomized to the rucaparib arm and discontinued prior to receiving study drug. Reasons for discontinuation were due to withdrawal of consent, physician decision, and laboratory value (did not meet eligibility criteria)	1.1% 2/189 • Adverse events were reported from the date of first dose of study drug and until 28 days after last dose of study drug, approximately 8.2 years. Three patients were randomized to the rucaparib arm and discontinued prior to receiving study drug. Reasons for discontinuation were due to withdrawal of consent, physician decision, and laboratory value (did not meet eligibility criteria)
Gastrointestinal disorders Diarrhoea	0.27% 1/372 • Adverse events were reported from the date of first dose of study drug and until 28 days after last dose of study drug, approximately 8.2 years. Three patients were randomized to the rucaparib arm and discontinued prior to receiving study drug. Reasons for discontinuation were due to withdrawal of consent, physician decision, and laboratory value (did not meet eligibility criteria)	0.53% 1/189 • Adverse events were reported from the date of first dose of study drug and until 28 days after last dose of study drug, approximately 8.2 years. Three patients were randomized to the rucaparib arm and discontinued prior to receiving study drug. Reasons for discontinuation were due to withdrawal of consent, physician decision, and laboratory value (did not meet eligibility criteria)
Gastrointestinal disorders Duodenal obstruction	0.27% 1/372 • Adverse events were reported from the date of first dose of study drug and until 28 days after last dose of study drug, approximately 8.2 years. Three patients were randomized to the rucaparib arm and discontinued prior to receiving study drug. Reasons for discontinuation were due to withdrawal of consent, physician decision, and laboratory value (did not meet eligibility criteria)	0.00% 0/189 • Adverse events were reported from the date of first dose of study drug and until 28 days after last dose of study drug, approximately 8.2 years. Three patients were randomized to the rucaparib arm and discontinued prior to receiving study drug. Reasons for discontinuation were due to withdrawal of consent, physician decision, and laboratory value (did not meet eligibility criteria)
Gastrointestinal disorders Faecaloma	0.27% 1/372 • Adverse events were reported from the date of first dose of study drug and until 28 days after last dose of study drug, approximately 8.2 years. Three patients were randomized to the rucaparib arm and discontinued prior to receiving study drug. Reasons for discontinuation were due to withdrawal of consent, physician decision, and laboratory value (did not meet eligibility criteria)	0.00% 0/189 • Adverse events were reported from the date of first dose of study drug and until 28 days after last dose of study drug, approximately 8.2 years. Three patients were randomized to the rucaparib arm and discontinued prior to receiving study drug. Reasons for discontinuation were due to withdrawal of consent, physician decision, and laboratory value (did not meet eligibility criteria)
Gastrointestinal disorders Gastrointestinal pain	0.81% 3/372 • Adverse events were reported from the date of first dose of study drug and until 28 days after last dose of study drug, approximately 8.2 years. Three patients were randomized to the rucaparib arm and discontinued prior to receiving study drug. Reasons for discontinuation were due to withdrawal of consent, physician decision, and laboratory value (did not meet eligibility criteria)	1.1% 2/189 • Adverse events were reported from the date of first dose of study drug and until 28 days after last dose of study drug, approximately 8.2 years. Three patients were randomized to the rucaparib arm and discontinued prior to receiving study drug. Reasons for discontinuation were due to withdrawal of consent, physician decision, and laboratory value (did not meet eligibility criteria)
Gastrointestinal disorders Intestinal obstruction	0.54% 2/372 • Adverse events were reported from the date of first dose of study drug and until 28 days after last dose of study drug, approximately 8.2 years. Three patients were randomized to the rucaparib arm and discontinued prior to receiving study drug. Reasons for discontinuation were due to withdrawal of consent, physician decision, and laboratory value (did not meet eligibility criteria)	0.53% 1/189 • Adverse events were reported from the date of first dose of study drug and until 28 days after last dose of study drug, approximately 8.2 years. Three patients were randomized to the rucaparib arm and discontinued prior to receiving study drug. Reasons for discontinuation were due to withdrawal of consent, physician decision, and laboratory value (did not meet eligibility criteria)
Gastrointestinal disorders Nausea	0.27% 1/372 • Adverse events were reported from the date of first dose of study drug and until 28 days after last dose of study drug, approximately 8.2 years. Three patients were randomized to the rucaparib arm and discontinued prior to receiving study drug. Reasons for discontinuation were due to withdrawal of consent, physician decision, and laboratory value (did not meet eligibility criteria)	0.00% 0/189 • Adverse events were reported from the date of first dose of study drug and until 28 days after last dose of study drug, approximately 8.2 years. Three patients were randomized to the rucaparib arm and discontinued prior to receiving study drug. Reasons for discontinuation were due to withdrawal of consent, physician decision, and laboratory value (did not meet eligibility criteria)
Gastrointestinal disorders Neutropenic colitis	0.27% 1/372 • Adverse events were reported from the date of first dose of study drug and until 28 days after last dose of study drug, approximately 8.2 years. Three patients were randomized to the rucaparib arm and discontinued prior to receiving study drug. Reasons for discontinuation were due to withdrawal of consent, physician decision, and laboratory value (did not meet eligibility criteria)	0.00% 0/189 • Adverse events were reported from the date of first dose of study drug and until 28 days after last dose of study drug, approximately 8.2 years. Three patients were randomized to the rucaparib arm and discontinued prior to receiving study drug. Reasons for discontinuation were due to withdrawal of consent, physician decision, and laboratory value (did not meet eligibility criteria)
Gastrointestinal disorders Small intestinal obstruction	1.1% 4/372 • Adverse events were reported from the date of first dose of study drug and until 28 days after last dose of study drug, approximately 8.2 years. Three patients were randomized to the rucaparib arm and discontinued prior to receiving study drug. Reasons for discontinuation were due to withdrawal of consent, physician decision, and laboratory value (did not meet eligibility criteria)	1.6% 3/189 • Adverse events were reported from the date of first dose of study drug and until 28 days after last dose of study drug, approximately 8.2 years. Three patients were randomized to the rucaparib arm and discontinued prior to receiving study drug. Reasons for discontinuation were due to withdrawal of consent, physician decision, and laboratory value (did not meet eligibility criteria)
Gastrointestinal disorders Vomiting	2.4% 9/372 • Adverse events were reported from the date of first dose of study drug and until 28 days after last dose of study drug, approximately 8.2 years. Three patients were randomized to the rucaparib arm and discontinued prior to receiving study drug. Reasons for discontinuation were due to withdrawal of consent, physician decision, and laboratory value (did not meet eligibility criteria)	1.1% 2/189 • Adverse events were reported from the date of first dose of study drug and until 28 days after last dose of study drug, approximately 8.2 years. Three patients were randomized to the rucaparib arm and discontinued prior to receiving study drug. Reasons for discontinuation were due to withdrawal of consent, physician decision, and laboratory value (did not meet eligibility criteria)
General disorders General physical health deterioration	0.54% 2/372 • Adverse events were reported from the date of first dose of study drug and until 28 days after last dose of study drug, approximately 8.2 years. Three patients were randomized to the rucaparib arm and discontinued prior to receiving study drug. Reasons for discontinuation were due to withdrawal of consent, physician decision, and laboratory value (did not meet eligibility criteria)	0.00% 0/189 • Adverse events were reported from the date of first dose of study drug and until 28 days after last dose of study drug, approximately 8.2 years. Three patients were randomized to the rucaparib arm and discontinued prior to receiving study drug. Reasons for discontinuation were due to withdrawal of consent, physician decision, and laboratory value (did not meet eligibility criteria)
General disorders Incarcerated hernia	0.54% 2/372 • Adverse events were reported from the date of first dose of study drug and until 28 days after last dose of study drug, approximately 8.2 years. Three patients were randomized to the rucaparib arm and discontinued prior to receiving study drug. Reasons for discontinuation were due to withdrawal of consent, physician decision, and laboratory value (did not meet eligibility criteria)	0.00% 0/189 • Adverse events were reported from the date of first dose of study drug and until 28 days after last dose of study drug, approximately 8.2 years. Three patients were randomized to the rucaparib arm and discontinued prior to receiving study drug. Reasons for discontinuation were due to withdrawal of consent, physician decision, and laboratory value (did not meet eligibility criteria)
General disorders Pyrexia	1.6% 6/372 • Adverse events were reported from the date of first dose of study drug and until 28 days after last dose of study drug, approximately 8.2 years. Three patients were randomized to the rucaparib arm and discontinued prior to receiving study drug. Reasons for discontinuation were due to withdrawal of consent, physician decision, and laboratory value (did not meet eligibility criteria)	0.00% 0/189 • Adverse events were reported from the date of first dose of study drug and until 28 days after last dose of study drug, approximately 8.2 years. Three patients were randomized to the rucaparib arm and discontinued prior to receiving study drug. Reasons for discontinuation were due to withdrawal of consent, physician decision, and laboratory value (did not meet eligibility criteria)
Hepatobiliary disorders Cholecystitis	0.27% 1/372 • Adverse events were reported from the date of first dose of study drug and until 28 days after last dose of study drug, approximately 8.2 years. Three patients were randomized to the rucaparib arm and discontinued prior to receiving study drug. Reasons for discontinuation were due to withdrawal of consent, physician decision, and laboratory value (did not meet eligibility criteria)	0.00% 0/189 • Adverse events were reported from the date of first dose of study drug and until 28 days after last dose of study drug, approximately 8.2 years. Three patients were randomized to the rucaparib arm and discontinued prior to receiving study drug. Reasons for discontinuation were due to withdrawal of consent, physician decision, and laboratory value (did not meet eligibility criteria)
Infections and infestations Arthritis infective	0.27% 1/372 • Adverse events were reported from the date of first dose of study drug and until 28 days after last dose of study drug, approximately 8.2 years. Three patients were randomized to the rucaparib arm and discontinued prior to receiving study drug. Reasons for discontinuation were due to withdrawal of consent, physician decision, and laboratory value (did not meet eligibility criteria)	0.00% 0/189 • Adverse events were reported from the date of first dose of study drug and until 28 days after last dose of study drug, approximately 8.2 years. Three patients were randomized to the rucaparib arm and discontinued prior to receiving study drug. Reasons for discontinuation were due to withdrawal of consent, physician decision, and laboratory value (did not meet eligibility criteria)
Infections and infestations Cellulitis	0.27% 1/372 • Adverse events were reported from the date of first dose of study drug and until 28 days after last dose of study drug, approximately 8.2 years. Three patients were randomized to the rucaparib arm and discontinued prior to receiving study drug. Reasons for discontinuation were due to withdrawal of consent, physician decision, and laboratory value (did not meet eligibility criteria)	0.00% 0/189 • Adverse events were reported from the date of first dose of study drug and until 28 days after last dose of study drug, approximately 8.2 years. Three patients were randomized to the rucaparib arm and discontinued prior to receiving study drug. Reasons for discontinuation were due to withdrawal of consent, physician decision, and laboratory value (did not meet eligibility criteria)
Infections and infestations Gastroenteritis	0.27% 1/372 • Adverse events were reported from the date of first dose of study drug and until 28 days after last dose of study drug, approximately 8.2 years. Three patients were randomized to the rucaparib arm and discontinued prior to receiving study drug. Reasons for discontinuation were due to withdrawal of consent, physician decision, and laboratory value (did not meet eligibility criteria)	0.00% 0/189 • Adverse events were reported from the date of first dose of study drug and until 28 days after last dose of study drug, approximately 8.2 years. Three patients were randomized to the rucaparib arm and discontinued prior to receiving study drug. Reasons for discontinuation were due to withdrawal of consent, physician decision, and laboratory value (did not meet eligibility criteria)
Infections and infestations Lower respiratory tract infection	0.27% 1/372 • Adverse events were reported from the date of first dose of study drug and until 28 days after last dose of study drug, approximately 8.2 years. Three patients were randomized to the rucaparib arm and discontinued prior to receiving study drug. Reasons for discontinuation were due to withdrawal of consent, physician decision, and laboratory value (did not meet eligibility criteria)	0.00% 0/189 • Adverse events were reported from the date of first dose of study drug and until 28 days after last dose of study drug, approximately 8.2 years. Three patients were randomized to the rucaparib arm and discontinued prior to receiving study drug. Reasons for discontinuation were due to withdrawal of consent, physician decision, and laboratory value (did not meet eligibility criteria)
Infections and infestations Pyelonephritis	0.27% 1/372 • Adverse events were reported from the date of first dose of study drug and until 28 days after last dose of study drug, approximately 8.2 years. Three patients were randomized to the rucaparib arm and discontinued prior to receiving study drug. Reasons for discontinuation were due to withdrawal of consent, physician decision, and laboratory value (did not meet eligibility criteria)	0.00% 0/189 • Adverse events were reported from the date of first dose of study drug and until 28 days after last dose of study drug, approximately 8.2 years. Three patients were randomized to the rucaparib arm and discontinued prior to receiving study drug. Reasons for discontinuation were due to withdrawal of consent, physician decision, and laboratory value (did not meet eligibility criteria)
Infections and infestations Sepsis	0.54% 2/372 • Adverse events were reported from the date of first dose of study drug and until 28 days after last dose of study drug, approximately 8.2 years. Three patients were randomized to the rucaparib arm and discontinued prior to receiving study drug. Reasons for discontinuation were due to withdrawal of consent, physician decision, and laboratory value (did not meet eligibility criteria)	0.00% 0/189 • Adverse events were reported from the date of first dose of study drug and until 28 days after last dose of study drug, approximately 8.2 years. Three patients were randomized to the rucaparib arm and discontinued prior to receiving study drug. Reasons for discontinuation were due to withdrawal of consent, physician decision, and laboratory value (did not meet eligibility criteria)
Infections and infestations Sinusitis	0.27% 1/372 • Adverse events were reported from the date of first dose of study drug and until 28 days after last dose of study drug, approximately 8.2 years. Three patients were randomized to the rucaparib arm and discontinued prior to receiving study drug. Reasons for discontinuation were due to withdrawal of consent, physician decision, and laboratory value (did not meet eligibility criteria)	0.00% 0/189 • Adverse events were reported from the date of first dose of study drug and until 28 days after last dose of study drug, approximately 8.2 years. Three patients were randomized to the rucaparib arm and discontinued prior to receiving study drug. Reasons for discontinuation were due to withdrawal of consent, physician decision, and laboratory value (did not meet eligibility criteria)
Infections and infestations Stoma site infection	0.00% 0/372 • Adverse events were reported from the date of first dose of study drug and until 28 days after last dose of study drug, approximately 8.2 years. Three patients were randomized to the rucaparib arm and discontinued prior to receiving study drug. Reasons for discontinuation were due to withdrawal of consent, physician decision, and laboratory value (did not meet eligibility criteria)	0.53% 1/189 • Adverse events were reported from the date of first dose of study drug and until 28 days after last dose of study drug, approximately 8.2 years. Three patients were randomized to the rucaparib arm and discontinued prior to receiving study drug. Reasons for discontinuation were due to withdrawal of consent, physician decision, and laboratory value (did not meet eligibility criteria)
Infections and infestations Upper respiratory tract infection	0.00% 0/372 • Adverse events were reported from the date of first dose of study drug and until 28 days after last dose of study drug, approximately 8.2 years. Three patients were randomized to the rucaparib arm and discontinued prior to receiving study drug. Reasons for discontinuation were due to withdrawal of consent, physician decision, and laboratory value (did not meet eligibility criteria)	0.53% 1/189 • Adverse events were reported from the date of first dose of study drug and until 28 days after last dose of study drug, approximately 8.2 years. Three patients were randomized to the rucaparib arm and discontinued prior to receiving study drug. Reasons for discontinuation were due to withdrawal of consent, physician decision, and laboratory value (did not meet eligibility criteria)
Infections and infestations Urinary tract infection	0.54% 2/372 • Adverse events were reported from the date of first dose of study drug and until 28 days after last dose of study drug, approximately 8.2 years. Three patients were randomized to the rucaparib arm and discontinued prior to receiving study drug. Reasons for discontinuation were due to withdrawal of consent, physician decision, and laboratory value (did not meet eligibility criteria)	0.53% 1/189 • Adverse events were reported from the date of first dose of study drug and until 28 days after last dose of study drug, approximately 8.2 years. Three patients were randomized to the rucaparib arm and discontinued prior to receiving study drug. Reasons for discontinuation were due to withdrawal of consent, physician decision, and laboratory value (did not meet eligibility criteria)
Infections and infestations Varicella	0.00% 0/372 • Adverse events were reported from the date of first dose of study drug and until 28 days after last dose of study drug, approximately 8.2 years. Three patients were randomized to the rucaparib arm and discontinued prior to receiving study drug. Reasons for discontinuation were due to withdrawal of consent, physician decision, and laboratory value (did not meet eligibility criteria)	0.53% 1/189 • Adverse events were reported from the date of first dose of study drug and until 28 days after last dose of study drug, approximately 8.2 years. Three patients were randomized to the rucaparib arm and discontinued prior to receiving study drug. Reasons for discontinuation were due to withdrawal of consent, physician decision, and laboratory value (did not meet eligibility criteria)
Infections and infestations Viral infection	0.27% 1/372 • Adverse events were reported from the date of first dose of study drug and until 28 days after last dose of study drug, approximately 8.2 years. Three patients were randomized to the rucaparib arm and discontinued prior to receiving study drug. Reasons for discontinuation were due to withdrawal of consent, physician decision, and laboratory value (did not meet eligibility criteria)	0.00% 0/189 • Adverse events were reported from the date of first dose of study drug and until 28 days after last dose of study drug, approximately 8.2 years. Three patients were randomized to the rucaparib arm and discontinued prior to receiving study drug. Reasons for discontinuation were due to withdrawal of consent, physician decision, and laboratory value (did not meet eligibility criteria)
Injury, poisoning and procedural complications Femoral neck fracture	0.27% 1/372 • Adverse events were reported from the date of first dose of study drug and until 28 days after last dose of study drug, approximately 8.2 years. Three patients were randomized to the rucaparib arm and discontinued prior to receiving study drug. Reasons for discontinuation were due to withdrawal of consent, physician decision, and laboratory value (did not meet eligibility criteria)	0.53% 1/189 • Adverse events were reported from the date of first dose of study drug and until 28 days after last dose of study drug, approximately 8.2 years. Three patients were randomized to the rucaparib arm and discontinued prior to receiving study drug. Reasons for discontinuation were due to withdrawal of consent, physician decision, and laboratory value (did not meet eligibility criteria)
Injury, poisoning and procedural complications Femur fracture	0.27% 1/372 • Adverse events were reported from the date of first dose of study drug and until 28 days after last dose of study drug, approximately 8.2 years. Three patients were randomized to the rucaparib arm and discontinued prior to receiving study drug. Reasons for discontinuation were due to withdrawal of consent, physician decision, and laboratory value (did not meet eligibility criteria)	0.00% 0/189 • Adverse events were reported from the date of first dose of study drug and until 28 days after last dose of study drug, approximately 8.2 years. Three patients were randomized to the rucaparib arm and discontinued prior to receiving study drug. Reasons for discontinuation were due to withdrawal of consent, physician decision, and laboratory value (did not meet eligibility criteria)
Injury, poisoning and procedural complications Fibula fracture	0.27% 1/372 • Adverse events were reported from the date of first dose of study drug and until 28 days after last dose of study drug, approximately 8.2 years. Three patients were randomized to the rucaparib arm and discontinued prior to receiving study drug. Reasons for discontinuation were due to withdrawal of consent, physician decision, and laboratory value (did not meet eligibility criteria)	0.00% 0/189 • Adverse events were reported from the date of first dose of study drug and until 28 days after last dose of study drug, approximately 8.2 years. Three patients were randomized to the rucaparib arm and discontinued prior to receiving study drug. Reasons for discontinuation were due to withdrawal of consent, physician decision, and laboratory value (did not meet eligibility criteria)
Injury, poisoning and procedural complications Forearm fracture	0.00% 0/372 • Adverse events were reported from the date of first dose of study drug and until 28 days after last dose of study drug, approximately 8.2 years. Three patients were randomized to the rucaparib arm and discontinued prior to receiving study drug. Reasons for discontinuation were due to withdrawal of consent, physician decision, and laboratory value (did not meet eligibility criteria)	0.53% 1/189 • Adverse events were reported from the date of first dose of study drug and until 28 days after last dose of study drug, approximately 8.2 years. Three patients were randomized to the rucaparib arm and discontinued prior to receiving study drug. Reasons for discontinuation were due to withdrawal of consent, physician decision, and laboratory value (did not meet eligibility criteria)
Injury, poisoning and procedural complications Incisional hernia	0.00% 0/372 • Adverse events were reported from the date of first dose of study drug and until 28 days after last dose of study drug, approximately 8.2 years. Three patients were randomized to the rucaparib arm and discontinued prior to receiving study drug. Reasons for discontinuation were due to withdrawal of consent, physician decision, and laboratory value (did not meet eligibility criteria)	0.53% 1/189 • Adverse events were reported from the date of first dose of study drug and until 28 days after last dose of study drug, approximately 8.2 years. Three patients were randomized to the rucaparib arm and discontinued prior to receiving study drug. Reasons for discontinuation were due to withdrawal of consent, physician decision, and laboratory value (did not meet eligibility criteria)
Injury, poisoning and procedural complications Tibia fracture	0.27% 1/372 • Adverse events were reported from the date of first dose of study drug and until 28 days after last dose of study drug, approximately 8.2 years. Three patients were randomized to the rucaparib arm and discontinued prior to receiving study drug. Reasons for discontinuation were due to withdrawal of consent, physician decision, and laboratory value (did not meet eligibility criteria)	0.00% 0/189 • Adverse events were reported from the date of first dose of study drug and until 28 days after last dose of study drug, approximately 8.2 years. Three patients were randomized to the rucaparib arm and discontinued prior to receiving study drug. Reasons for discontinuation were due to withdrawal of consent, physician decision, and laboratory value (did not meet eligibility criteria)
Investigations Blood creatinine increased	0.81% 3/372 • Adverse events were reported from the date of first dose of study drug and until 28 days after last dose of study drug, approximately 8.2 years. Three patients were randomized to the rucaparib arm and discontinued prior to receiving study drug. Reasons for discontinuation were due to withdrawal of consent, physician decision, and laboratory value (did not meet eligibility criteria)	0.00% 0/189 • Adverse events were reported from the date of first dose of study drug and until 28 days after last dose of study drug, approximately 8.2 years. Three patients were randomized to the rucaparib arm and discontinued prior to receiving study drug. Reasons for discontinuation were due to withdrawal of consent, physician decision, and laboratory value (did not meet eligibility criteria)
Investigations Gastrointestinal stoma output increased	0.27% 1/372 • Adverse events were reported from the date of first dose of study drug and until 28 days after last dose of study drug, approximately 8.2 years. Three patients were randomized to the rucaparib arm and discontinued prior to receiving study drug. Reasons for discontinuation were due to withdrawal of consent, physician decision, and laboratory value (did not meet eligibility criteria)	0.00% 0/189 • Adverse events were reported from the date of first dose of study drug and until 28 days after last dose of study drug, approximately 8.2 years. Three patients were randomized to the rucaparib arm and discontinued prior to receiving study drug. Reasons for discontinuation were due to withdrawal of consent, physician decision, and laboratory value (did not meet eligibility criteria)
Investigations White blood cell count decreased	0.27% 1/372 • Adverse events were reported from the date of first dose of study drug and until 28 days after last dose of study drug, approximately 8.2 years. Three patients were randomized to the rucaparib arm and discontinued prior to receiving study drug. Reasons for discontinuation were due to withdrawal of consent, physician decision, and laboratory value (did not meet eligibility criteria)	0.00% 0/189 • Adverse events were reported from the date of first dose of study drug and until 28 days after last dose of study drug, approximately 8.2 years. Three patients were randomized to the rucaparib arm and discontinued prior to receiving study drug. Reasons for discontinuation were due to withdrawal of consent, physician decision, and laboratory value (did not meet eligibility criteria)
Metabolism and nutrition disorders Decreased appetite	0.27% 1/372 • Adverse events were reported from the date of first dose of study drug and until 28 days after last dose of study drug, approximately 8.2 years. Three patients were randomized to the rucaparib arm and discontinued prior to receiving study drug. Reasons for discontinuation were due to withdrawal of consent, physician decision, and laboratory value (did not meet eligibility criteria)	0.00% 0/189 • Adverse events were reported from the date of first dose of study drug and until 28 days after last dose of study drug, approximately 8.2 years. Three patients were randomized to the rucaparib arm and discontinued prior to receiving study drug. Reasons for discontinuation were due to withdrawal of consent, physician decision, and laboratory value (did not meet eligibility criteria)
Metabolism and nutrition disorders Dehydration	0.81% 3/372 • Adverse events were reported from the date of first dose of study drug and until 28 days after last dose of study drug, approximately 8.2 years. Three patients were randomized to the rucaparib arm and discontinued prior to receiving study drug. Reasons for discontinuation were due to withdrawal of consent, physician decision, and laboratory value (did not meet eligibility criteria)	0.00% 0/189 • Adverse events were reported from the date of first dose of study drug and until 28 days after last dose of study drug, approximately 8.2 years. Three patients were randomized to the rucaparib arm and discontinued prior to receiving study drug. Reasons for discontinuation were due to withdrawal of consent, physician decision, and laboratory value (did not meet eligibility criteria)
Metabolism and nutrition disorders Hyponatraemia	0.00% 0/372 • Adverse events were reported from the date of first dose of study drug and until 28 days after last dose of study drug, approximately 8.2 years. Three patients were randomized to the rucaparib arm and discontinued prior to receiving study drug. Reasons for discontinuation were due to withdrawal of consent, physician decision, and laboratory value (did not meet eligibility criteria)	0.53% 1/189 • Adverse events were reported from the date of first dose of study drug and until 28 days after last dose of study drug, approximately 8.2 years. Three patients were randomized to the rucaparib arm and discontinued prior to receiving study drug. Reasons for discontinuation were due to withdrawal of consent, physician decision, and laboratory value (did not meet eligibility criteria)
Musculoskeletal and connective tissue disorders Back pain	0.27% 1/372 • Adverse events were reported from the date of first dose of study drug and until 28 days after last dose of study drug, approximately 8.2 years. Three patients were randomized to the rucaparib arm and discontinued prior to receiving study drug. Reasons for discontinuation were due to withdrawal of consent, physician decision, and laboratory value (did not meet eligibility criteria)	0.00% 0/189 • Adverse events were reported from the date of first dose of study drug and until 28 days after last dose of study drug, approximately 8.2 years. Three patients were randomized to the rucaparib arm and discontinued prior to receiving study drug. Reasons for discontinuation were due to withdrawal of consent, physician decision, and laboratory value (did not meet eligibility criteria)
Musculoskeletal and connective tissue disorders Groin pain	0.27% 1/372 • Adverse events were reported from the date of first dose of study drug and until 28 days after last dose of study drug, approximately 8.2 years. Three patients were randomized to the rucaparib arm and discontinued prior to receiving study drug. Reasons for discontinuation were due to withdrawal of consent, physician decision, and laboratory value (did not meet eligibility criteria)	0.00% 0/189 • Adverse events were reported from the date of first dose of study drug and until 28 days after last dose of study drug, approximately 8.2 years. Three patients were randomized to the rucaparib arm and discontinued prior to receiving study drug. Reasons for discontinuation were due to withdrawal of consent, physician decision, and laboratory value (did not meet eligibility criteria)
Musculoskeletal and connective tissue disorders Muscular weakness	0.54% 2/372 • Adverse events were reported from the date of first dose of study drug and until 28 days after last dose of study drug, approximately 8.2 years. Three patients were randomized to the rucaparib arm and discontinued prior to receiving study drug. Reasons for discontinuation were due to withdrawal of consent, physician decision, and laboratory value (did not meet eligibility criteria)	0.00% 0/189 • Adverse events were reported from the date of first dose of study drug and until 28 days after last dose of study drug, approximately 8.2 years. Three patients were randomized to the rucaparib arm and discontinued prior to receiving study drug. Reasons for discontinuation were due to withdrawal of consent, physician decision, and laboratory value (did not meet eligibility criteria)
Musculoskeletal and connective tissue disorders Osteoarthritis	0.81% 3/372 • Adverse events were reported from the date of first dose of study drug and until 28 days after last dose of study drug, approximately 8.2 years. Three patients were randomized to the rucaparib arm and discontinued prior to receiving study drug. Reasons for discontinuation were due to withdrawal of consent, physician decision, and laboratory value (did not meet eligibility criteria)	0.00% 0/189 • Adverse events were reported from the date of first dose of study drug and until 28 days after last dose of study drug, approximately 8.2 years. Three patients were randomized to the rucaparib arm and discontinued prior to receiving study drug. Reasons for discontinuation were due to withdrawal of consent, physician decision, and laboratory value (did not meet eligibility criteria)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Acute myeloid leukaemia	0.27% 1/372 • Adverse events were reported from the date of first dose of study drug and until 28 days after last dose of study drug, approximately 8.2 years. Three patients were randomized to the rucaparib arm and discontinued prior to receiving study drug. Reasons for discontinuation were due to withdrawal of consent, physician decision, and laboratory value (did not meet eligibility criteria)	0.00% 0/189 • Adverse events were reported from the date of first dose of study drug and until 28 days after last dose of study drug, approximately 8.2 years. Three patients were randomized to the rucaparib arm and discontinued prior to receiving study drug. Reasons for discontinuation were due to withdrawal of consent, physician decision, and laboratory value (did not meet eligibility criteria)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) B-cell unclassifiable lymphoma high grade	0.27% 1/372 • Adverse events were reported from the date of first dose of study drug and until 28 days after last dose of study drug, approximately 8.2 years. Three patients were randomized to the rucaparib arm and discontinued prior to receiving study drug. Reasons for discontinuation were due to withdrawal of consent, physician decision, and laboratory value (did not meet eligibility criteria)	0.00% 0/189 • Adverse events were reported from the date of first dose of study drug and until 28 days after last dose of study drug, approximately 8.2 years. Three patients were randomized to the rucaparib arm and discontinued prior to receiving study drug. Reasons for discontinuation were due to withdrawal of consent, physician decision, and laboratory value (did not meet eligibility criteria)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Malignant melanoma	0.54% 2/372 • Adverse events were reported from the date of first dose of study drug and until 28 days after last dose of study drug, approximately 8.2 years. Three patients were randomized to the rucaparib arm and discontinued prior to receiving study drug. Reasons for discontinuation were due to withdrawal of consent, physician decision, and laboratory value (did not meet eligibility criteria)	0.00% 0/189 • Adverse events were reported from the date of first dose of study drug and until 28 days after last dose of study drug, approximately 8.2 years. Three patients were randomized to the rucaparib arm and discontinued prior to receiving study drug. Reasons for discontinuation were due to withdrawal of consent, physician decision, and laboratory value (did not meet eligibility criteria)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Malignant neoplasm progression	0.54% 2/372 • Adverse events were reported from the date of first dose of study drug and until 28 days after last dose of study drug, approximately 8.2 years. Three patients were randomized to the rucaparib arm and discontinued prior to receiving study drug. Reasons for discontinuation were due to withdrawal of consent, physician decision, and laboratory value (did not meet eligibility criteria)	0.00% 0/189 • Adverse events were reported from the date of first dose of study drug and until 28 days after last dose of study drug, approximately 8.2 years. Three patients were randomized to the rucaparib arm and discontinued prior to receiving study drug. Reasons for discontinuation were due to withdrawal of consent, physician decision, and laboratory value (did not meet eligibility criteria)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastases to meninges	0.00% 0/372 • Adverse events were reported from the date of first dose of study drug and until 28 days after last dose of study drug, approximately 8.2 years. Three patients were randomized to the rucaparib arm and discontinued prior to receiving study drug. Reasons for discontinuation were due to withdrawal of consent, physician decision, and laboratory value (did not meet eligibility criteria)	0.53% 1/189 • Adverse events were reported from the date of first dose of study drug and until 28 days after last dose of study drug, approximately 8.2 years. Three patients were randomized to the rucaparib arm and discontinued prior to receiving study drug. Reasons for discontinuation were due to withdrawal of consent, physician decision, and laboratory value (did not meet eligibility criteria)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Myelodysplastic syndrome	1.3% 5/372 • Adverse events were reported from the date of first dose of study drug and until 28 days after last dose of study drug, approximately 8.2 years. Three patients were randomized to the rucaparib arm and discontinued prior to receiving study drug. Reasons for discontinuation were due to withdrawal of consent, physician decision, and laboratory value (did not meet eligibility criteria)	0.00% 0/189 • Adverse events were reported from the date of first dose of study drug and until 28 days after last dose of study drug, approximately 8.2 years. Three patients were randomized to the rucaparib arm and discontinued prior to receiving study drug. Reasons for discontinuation were due to withdrawal of consent, physician decision, and laboratory value (did not meet eligibility criteria)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Squamous cell carcinoma of lung	0.27% 1/372 • Adverse events were reported from the date of first dose of study drug and until 28 days after last dose of study drug, approximately 8.2 years. Three patients were randomized to the rucaparib arm and discontinued prior to receiving study drug. Reasons for discontinuation were due to withdrawal of consent, physician decision, and laboratory value (did not meet eligibility criteria)	0.00% 0/189 • Adverse events were reported from the date of first dose of study drug and until 28 days after last dose of study drug, approximately 8.2 years. Three patients were randomized to the rucaparib arm and discontinued prior to receiving study drug. Reasons for discontinuation were due to withdrawal of consent, physician decision, and laboratory value (did not meet eligibility criteria)
Nervous system disorders Amnesia	0.27% 1/372 • Adverse events were reported from the date of first dose of study drug and until 28 days after last dose of study drug, approximately 8.2 years. Three patients were randomized to the rucaparib arm and discontinued prior to receiving study drug. Reasons for discontinuation were due to withdrawal of consent, physician decision, and laboratory value (did not meet eligibility criteria)	0.00% 0/189 • Adverse events were reported from the date of first dose of study drug and until 28 days after last dose of study drug, approximately 8.2 years. Three patients were randomized to the rucaparib arm and discontinued prior to receiving study drug. Reasons for discontinuation were due to withdrawal of consent, physician decision, and laboratory value (did not meet eligibility criteria)
Nervous system disorders Cognitive disorder	0.27% 1/372 • Adverse events were reported from the date of first dose of study drug and until 28 days after last dose of study drug, approximately 8.2 years. Three patients were randomized to the rucaparib arm and discontinued prior to receiving study drug. Reasons for discontinuation were due to withdrawal of consent, physician decision, and laboratory value (did not meet eligibility criteria)	0.00% 0/189 • Adverse events were reported from the date of first dose of study drug and until 28 days after last dose of study drug, approximately 8.2 years. Three patients were randomized to the rucaparib arm and discontinued prior to receiving study drug. Reasons for discontinuation were due to withdrawal of consent, physician decision, and laboratory value (did not meet eligibility criteria)
Nervous system disorders Hypoaesthesia	0.27% 1/372 • Adverse events were reported from the date of first dose of study drug and until 28 days after last dose of study drug, approximately 8.2 years. Three patients were randomized to the rucaparib arm and discontinued prior to receiving study drug. Reasons for discontinuation were due to withdrawal of consent, physician decision, and laboratory value (did not meet eligibility criteria)	0.00% 0/189 • Adverse events were reported from the date of first dose of study drug and until 28 days after last dose of study drug, approximately 8.2 years. Three patients were randomized to the rucaparib arm and discontinued prior to receiving study drug. Reasons for discontinuation were due to withdrawal of consent, physician decision, and laboratory value (did not meet eligibility criteria)
Nervous system disorders Sciatica	0.27% 1/372 • Adverse events were reported from the date of first dose of study drug and until 28 days after last dose of study drug, approximately 8.2 years. Three patients were randomized to the rucaparib arm and discontinued prior to receiving study drug. Reasons for discontinuation were due to withdrawal of consent, physician decision, and laboratory value (did not meet eligibility criteria)	0.00% 0/189 • Adverse events were reported from the date of first dose of study drug and until 28 days after last dose of study drug, approximately 8.2 years. Three patients were randomized to the rucaparib arm and discontinued prior to receiving study drug. Reasons for discontinuation were due to withdrawal of consent, physician decision, and laboratory value (did not meet eligibility criteria)
Nervous system disorders Seizure	0.81% 3/372 • Adverse events were reported from the date of first dose of study drug and until 28 days after last dose of study drug, approximately 8.2 years. Three patients were randomized to the rucaparib arm and discontinued prior to receiving study drug. Reasons for discontinuation were due to withdrawal of consent, physician decision, and laboratory value (did not meet eligibility criteria)	0.00% 0/189 • Adverse events were reported from the date of first dose of study drug and until 28 days after last dose of study drug, approximately 8.2 years. Three patients were randomized to the rucaparib arm and discontinued prior to receiving study drug. Reasons for discontinuation were due to withdrawal of consent, physician decision, and laboratory value (did not meet eligibility criteria)
Psychiatric disorders Confusional state	0.27% 1/372 • Adverse events were reported from the date of first dose of study drug and until 28 days after last dose of study drug, approximately 8.2 years. Three patients were randomized to the rucaparib arm and discontinued prior to receiving study drug. Reasons for discontinuation were due to withdrawal of consent, physician decision, and laboratory value (did not meet eligibility criteria)	0.00% 0/189 • Adverse events were reported from the date of first dose of study drug and until 28 days after last dose of study drug, approximately 8.2 years. Three patients were randomized to the rucaparib arm and discontinued prior to receiving study drug. Reasons for discontinuation were due to withdrawal of consent, physician decision, and laboratory value (did not meet eligibility criteria)
Psychiatric disorders Mental status changes	0.27% 1/372 • Adverse events were reported from the date of first dose of study drug and until 28 days after last dose of study drug, approximately 8.2 years. Three patients were randomized to the rucaparib arm and discontinued prior to receiving study drug. Reasons for discontinuation were due to withdrawal of consent, physician decision, and laboratory value (did not meet eligibility criteria)	0.00% 0/189 • Adverse events were reported from the date of first dose of study drug and until 28 days after last dose of study drug, approximately 8.2 years. Three patients were randomized to the rucaparib arm and discontinued prior to receiving study drug. Reasons for discontinuation were due to withdrawal of consent, physician decision, and laboratory value (did not meet eligibility criteria)
Renal and urinary disorders Acute kidney injury	1.1% 4/372 • Adverse events were reported from the date of first dose of study drug and until 28 days after last dose of study drug, approximately 8.2 years. Three patients were randomized to the rucaparib arm and discontinued prior to receiving study drug. Reasons for discontinuation were due to withdrawal of consent, physician decision, and laboratory value (did not meet eligibility criteria)	0.00% 0/189 • Adverse events were reported from the date of first dose of study drug and until 28 days after last dose of study drug, approximately 8.2 years. Three patients were randomized to the rucaparib arm and discontinued prior to receiving study drug. Reasons for discontinuation were due to withdrawal of consent, physician decision, and laboratory value (did not meet eligibility criteria)
Renal and urinary disorders Renal failure	0.54% 2/372 • Adverse events were reported from the date of first dose of study drug and until 28 days after last dose of study drug, approximately 8.2 years. Three patients were randomized to the rucaparib arm and discontinued prior to receiving study drug. Reasons for discontinuation were due to withdrawal of consent, physician decision, and laboratory value (did not meet eligibility criteria)	0.00% 0/189 • Adverse events were reported from the date of first dose of study drug and until 28 days after last dose of study drug, approximately 8.2 years. Three patients were randomized to the rucaparib arm and discontinued prior to receiving study drug. Reasons for discontinuation were due to withdrawal of consent, physician decision, and laboratory value (did not meet eligibility criteria)
Renal and urinary disorders Urinary tract obstruction	0.27% 1/372 • Adverse events were reported from the date of first dose of study drug and until 28 days after last dose of study drug, approximately 8.2 years. Three patients were randomized to the rucaparib arm and discontinued prior to receiving study drug. Reasons for discontinuation were due to withdrawal of consent, physician decision, and laboratory value (did not meet eligibility criteria)	0.00% 0/189 • Adverse events were reported from the date of first dose of study drug and until 28 days after last dose of study drug, approximately 8.2 years. Three patients were randomized to the rucaparib arm and discontinued prior to receiving study drug. Reasons for discontinuation were due to withdrawal of consent, physician decision, and laboratory value (did not meet eligibility criteria)
Reproductive system and breast disorders Female genital tract fistula	0.27% 1/372 • Adverse events were reported from the date of first dose of study drug and until 28 days after last dose of study drug, approximately 8.2 years. Three patients were randomized to the rucaparib arm and discontinued prior to receiving study drug. Reasons for discontinuation were due to withdrawal of consent, physician decision, and laboratory value (did not meet eligibility criteria)	0.00% 0/189 • Adverse events were reported from the date of first dose of study drug and until 28 days after last dose of study drug, approximately 8.2 years. Three patients were randomized to the rucaparib arm and discontinued prior to receiving study drug. Reasons for discontinuation were due to withdrawal of consent, physician decision, and laboratory value (did not meet eligibility criteria)
Respiratory, thoracic and mediastinal disorders Acute pulmonary oedema	0.27% 1/372 • Adverse events were reported from the date of first dose of study drug and until 28 days after last dose of study drug, approximately 8.2 years. Three patients were randomized to the rucaparib arm and discontinued prior to receiving study drug. Reasons for discontinuation were due to withdrawal of consent, physician decision, and laboratory value (did not meet eligibility criteria)	0.00% 0/189 • Adverse events were reported from the date of first dose of study drug and until 28 days after last dose of study drug, approximately 8.2 years. Three patients were randomized to the rucaparib arm and discontinued prior to receiving study drug. Reasons for discontinuation were due to withdrawal of consent, physician decision, and laboratory value (did not meet eligibility criteria)
Respiratory, thoracic and mediastinal disorders Acute respiratory distress syndrome	0.27% 1/372 • Adverse events were reported from the date of first dose of study drug and until 28 days after last dose of study drug, approximately 8.2 years. Three patients were randomized to the rucaparib arm and discontinued prior to receiving study drug. Reasons for discontinuation were due to withdrawal of consent, physician decision, and laboratory value (did not meet eligibility criteria)	0.00% 0/189 • Adverse events were reported from the date of first dose of study drug and until 28 days after last dose of study drug, approximately 8.2 years. Three patients were randomized to the rucaparib arm and discontinued prior to receiving study drug. Reasons for discontinuation were due to withdrawal of consent, physician decision, and laboratory value (did not meet eligibility criteria)
Respiratory, thoracic and mediastinal disorders Cough	0.27% 1/372 • Adverse events were reported from the date of first dose of study drug and until 28 days after last dose of study drug, approximately 8.2 years. Three patients were randomized to the rucaparib arm and discontinued prior to receiving study drug. Reasons for discontinuation were due to withdrawal of consent, physician decision, and laboratory value (did not meet eligibility criteria)	0.00% 0/189 • Adverse events were reported from the date of first dose of study drug and until 28 days after last dose of study drug, approximately 8.2 years. Three patients were randomized to the rucaparib arm and discontinued prior to receiving study drug. Reasons for discontinuation were due to withdrawal of consent, physician decision, and laboratory value (did not meet eligibility criteria)
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.27% 1/372 • Adverse events were reported from the date of first dose of study drug and until 28 days after last dose of study drug, approximately 8.2 years. Three patients were randomized to the rucaparib arm and discontinued prior to receiving study drug. Reasons for discontinuation were due to withdrawal of consent, physician decision, and laboratory value (did not meet eligibility criteria)	0.00% 0/189 • Adverse events were reported from the date of first dose of study drug and until 28 days after last dose of study drug, approximately 8.2 years. Three patients were randomized to the rucaparib arm and discontinued prior to receiving study drug. Reasons for discontinuation were due to withdrawal of consent, physician decision, and laboratory value (did not meet eligibility criteria)
Respiratory, thoracic and mediastinal disorders Pleural effusion	0.27% 1/372 • Adverse events were reported from the date of first dose of study drug and until 28 days after last dose of study drug, approximately 8.2 years. Three patients were randomized to the rucaparib arm and discontinued prior to receiving study drug. Reasons for discontinuation were due to withdrawal of consent, physician decision, and laboratory value (did not meet eligibility criteria)	0.00% 0/189 • Adverse events were reported from the date of first dose of study drug and until 28 days after last dose of study drug, approximately 8.2 years. Three patients were randomized to the rucaparib arm and discontinued prior to receiving study drug. Reasons for discontinuation were due to withdrawal of consent, physician decision, and laboratory value (did not meet eligibility criteria)
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	0.54% 2/372 • Adverse events were reported from the date of first dose of study drug and until 28 days after last dose of study drug, approximately 8.2 years. Three patients were randomized to the rucaparib arm and discontinued prior to receiving study drug. Reasons for discontinuation were due to withdrawal of consent, physician decision, and laboratory value (did not meet eligibility criteria)	0.53% 1/189 • Adverse events were reported from the date of first dose of study drug and until 28 days after last dose of study drug, approximately 8.2 years. Three patients were randomized to the rucaparib arm and discontinued prior to receiving study drug. Reasons for discontinuation were due to withdrawal of consent, physician decision, and laboratory value (did not meet eligibility criteria)
Vascular disorders Hypertension	0.00% 0/372 • Adverse events were reported from the date of first dose of study drug and until 28 days after last dose of study drug, approximately 8.2 years. Three patients were randomized to the rucaparib arm and discontinued prior to receiving study drug. Reasons for discontinuation were due to withdrawal of consent, physician decision, and laboratory value (did not meet eligibility criteria)	0.53% 1/189 • Adverse events were reported from the date of first dose of study drug and until 28 days after last dose of study drug, approximately 8.2 years. Three patients were randomized to the rucaparib arm and discontinued prior to receiving study drug. Reasons for discontinuation were due to withdrawal of consent, physician decision, and laboratory value (did not meet eligibility criteria)
Vascular disorders Hypotension	0.27% 1/372 • Adverse events were reported from the date of first dose of study drug and until 28 days after last dose of study drug, approximately 8.2 years. Three patients were randomized to the rucaparib arm and discontinued prior to receiving study drug. Reasons for discontinuation were due to withdrawal of consent, physician decision, and laboratory value (did not meet eligibility criteria)	0.00% 0/189 • Adverse events were reported from the date of first dose of study drug and until 28 days after last dose of study drug, approximately 8.2 years. Three patients were randomized to the rucaparib arm and discontinued prior to receiving study drug. Reasons for discontinuation were due to withdrawal of consent, physician decision, and laboratory value (did not meet eligibility criteria)
Cardiac disorders Cardiac arrest	0.27% 1/372 • Adverse events were reported from the date of first dose of study drug and until 28 days after last dose of study drug, approximately 8.2 years. Three patients were randomized to the rucaparib arm and discontinued prior to receiving study drug. Reasons for discontinuation were due to withdrawal of consent, physician decision, and laboratory value (did not meet eligibility criteria)	0.00% 0/189 • Adverse events were reported from the date of first dose of study drug and until 28 days after last dose of study drug, approximately 8.2 years. Three patients were randomized to the rucaparib arm and discontinued prior to receiving study drug. Reasons for discontinuation were due to withdrawal of consent, physician decision, and laboratory value (did not meet eligibility criteria)
Blood and lymphatic system disorders Anaemia	4.8% 18/372 • Adverse events were reported from the date of first dose of study drug and until 28 days after last dose of study drug, approximately 8.2 years. Three patients were randomized to the rucaparib arm and discontinued prior to receiving study drug. Reasons for discontinuation were due to withdrawal of consent, physician decision, and laboratory value (did not meet eligibility criteria)	0.53% 1/189 • Adverse events were reported from the date of first dose of study drug and until 28 days after last dose of study drug, approximately 8.2 years. Three patients were randomized to the rucaparib arm and discontinued prior to receiving study drug. Reasons for discontinuation were due to withdrawal of consent, physician decision, and laboratory value (did not meet eligibility criteria)
Blood and lymphatic system disorders Neutropenia	0.54% 2/372 • Adverse events were reported from the date of first dose of study drug and until 28 days after last dose of study drug, approximately 8.2 years. Three patients were randomized to the rucaparib arm and discontinued prior to receiving study drug. Reasons for discontinuation were due to withdrawal of consent, physician decision, and laboratory value (did not meet eligibility criteria)	0.00% 0/189 • Adverse events were reported from the date of first dose of study drug and until 28 days after last dose of study drug, approximately 8.2 years. Three patients were randomized to the rucaparib arm and discontinued prior to receiving study drug. Reasons for discontinuation were due to withdrawal of consent, physician decision, and laboratory value (did not meet eligibility criteria)
Blood and lymphatic system disorders Thrombocytopenia	0.54% 2/372 • Adverse events were reported from the date of first dose of study drug and until 28 days after last dose of study drug, approximately 8.2 years. Three patients were randomized to the rucaparib arm and discontinued prior to receiving study drug. Reasons for discontinuation were due to withdrawal of consent, physician decision, and laboratory value (did not meet eligibility criteria)	0.00% 0/189 • Adverse events were reported from the date of first dose of study drug and until 28 days after last dose of study drug, approximately 8.2 years. Three patients were randomized to the rucaparib arm and discontinued prior to receiving study drug. Reasons for discontinuation were due to withdrawal of consent, physician decision, and laboratory value (did not meet eligibility criteria)
Gastrointestinal disorders Colitis	0.27% 1/372 • Adverse events were reported from the date of first dose of study drug and until 28 days after last dose of study drug, approximately 8.2 years. Three patients were randomized to the rucaparib arm and discontinued prior to receiving study drug. Reasons for discontinuation were due to withdrawal of consent, physician decision, and laboratory value (did not meet eligibility criteria)	0.00% 0/189 • Adverse events were reported from the date of first dose of study drug and until 28 days after last dose of study drug, approximately 8.2 years. Three patients were randomized to the rucaparib arm and discontinued prior to receiving study drug. Reasons for discontinuation were due to withdrawal of consent, physician decision, and laboratory value (did not meet eligibility criteria)
Gastrointestinal disorders Stomatitis	0.27% 1/372 • Adverse events were reported from the date of first dose of study drug and until 28 days after last dose of study drug, approximately 8.2 years. Three patients were randomized to the rucaparib arm and discontinued prior to receiving study drug. Reasons for discontinuation were due to withdrawal of consent, physician decision, and laboratory value (did not meet eligibility criteria)	0.00% 0/189 • Adverse events were reported from the date of first dose of study drug and until 28 days after last dose of study drug, approximately 8.2 years. Three patients were randomized to the rucaparib arm and discontinued prior to receiving study drug. Reasons for discontinuation were due to withdrawal of consent, physician decision, and laboratory value (did not meet eligibility criteria)
Gastrointestinal disorders Varices oesophageal	0.27% 1/372 • Adverse events were reported from the date of first dose of study drug and until 28 days after last dose of study drug, approximately 8.2 years. Three patients were randomized to the rucaparib arm and discontinued prior to receiving study drug. Reasons for discontinuation were due to withdrawal of consent, physician decision, and laboratory value (did not meet eligibility criteria)	0.00% 0/189 • Adverse events were reported from the date of first dose of study drug and until 28 days after last dose of study drug, approximately 8.2 years. Three patients were randomized to the rucaparib arm and discontinued prior to receiving study drug. Reasons for discontinuation were due to withdrawal of consent, physician decision, and laboratory value (did not meet eligibility criteria)
General disorders Asthenia	0.54% 2/372 • Adverse events were reported from the date of first dose of study drug and until 28 days after last dose of study drug, approximately 8.2 years. Three patients were randomized to the rucaparib arm and discontinued prior to receiving study drug. Reasons for discontinuation were due to withdrawal of consent, physician decision, and laboratory value (did not meet eligibility criteria)	0.00% 0/189 • Adverse events were reported from the date of first dose of study drug and until 28 days after last dose of study drug, approximately 8.2 years. Three patients were randomized to the rucaparib arm and discontinued prior to receiving study drug. Reasons for discontinuation were due to withdrawal of consent, physician decision, and laboratory value (did not meet eligibility criteria)
Hepatobiliary disorders Biliary obstruction	0.27% 1/372 • Adverse events were reported from the date of first dose of study drug and until 28 days after last dose of study drug, approximately 8.2 years. Three patients were randomized to the rucaparib arm and discontinued prior to receiving study drug. Reasons for discontinuation were due to withdrawal of consent, physician decision, and laboratory value (did not meet eligibility criteria)	0.00% 0/189 • Adverse events were reported from the date of first dose of study drug and until 28 days after last dose of study drug, approximately 8.2 years. Three patients were randomized to the rucaparib arm and discontinued prior to receiving study drug. Reasons for discontinuation were due to withdrawal of consent, physician decision, and laboratory value (did not meet eligibility criteria)
Hepatobiliary disorders Portal hypertension	0.27% 1/372 • Adverse events were reported from the date of first dose of study drug and until 28 days after last dose of study drug, approximately 8.2 years. Three patients were randomized to the rucaparib arm and discontinued prior to receiving study drug. Reasons for discontinuation were due to withdrawal of consent, physician decision, and laboratory value (did not meet eligibility criteria)	0.00% 0/189 • Adverse events were reported from the date of first dose of study drug and until 28 days after last dose of study drug, approximately 8.2 years. Three patients were randomized to the rucaparib arm and discontinued prior to receiving study drug. Reasons for discontinuation were due to withdrawal of consent, physician decision, and laboratory value (did not meet eligibility criteria)
Immune system disorders Haemophagocytic lymphohistiocytosis	0.27% 1/372 • Adverse events were reported from the date of first dose of study drug and until 28 days after last dose of study drug, approximately 8.2 years. Three patients were randomized to the rucaparib arm and discontinued prior to receiving study drug. Reasons for discontinuation were due to withdrawal of consent, physician decision, and laboratory value (did not meet eligibility criteria)	0.00% 0/189 • Adverse events were reported from the date of first dose of study drug and until 28 days after last dose of study drug, approximately 8.2 years. Three patients were randomized to the rucaparib arm and discontinued prior to receiving study drug. Reasons for discontinuation were due to withdrawal of consent, physician decision, and laboratory value (did not meet eligibility criteria)
Infections and infestations Pneumonia	0.00% 0/372 • Adverse events were reported from the date of first dose of study drug and until 28 days after last dose of study drug, approximately 8.2 years. Three patients were randomized to the rucaparib arm and discontinued prior to receiving study drug. Reasons for discontinuation were due to withdrawal of consent, physician decision, and laboratory value (did not meet eligibility criteria)	0.53% 1/189 • Adverse events were reported from the date of first dose of study drug and until 28 days after last dose of study drug, approximately 8.2 years. Three patients were randomized to the rucaparib arm and discontinued prior to receiving study drug. Reasons for discontinuation were due to withdrawal of consent, physician decision, and laboratory value (did not meet eligibility criteria)
Infections and infestations Viral upper respiratory tract infection	0.27% 1/372 • Adverse events were reported from the date of first dose of study drug and until 28 days after last dose of study drug, approximately 8.2 years. Three patients were randomized to the rucaparib arm and discontinued prior to receiving study drug. Reasons for discontinuation were due to withdrawal of consent, physician decision, and laboratory value (did not meet eligibility criteria)	0.00% 0/189 • Adverse events were reported from the date of first dose of study drug and until 28 days after last dose of study drug, approximately 8.2 years. Three patients were randomized to the rucaparib arm and discontinued prior to receiving study drug. Reasons for discontinuation were due to withdrawal of consent, physician decision, and laboratory value (did not meet eligibility criteria)
Injury, poisoning and procedural complications Fractured sacrum	0.27% 1/372 • Adverse events were reported from the date of first dose of study drug and until 28 days after last dose of study drug, approximately 8.2 years. Three patients were randomized to the rucaparib arm and discontinued prior to receiving study drug. Reasons for discontinuation were due to withdrawal of consent, physician decision, and laboratory value (did not meet eligibility criteria)	0.00% 0/189 • Adverse events were reported from the date of first dose of study drug and until 28 days after last dose of study drug, approximately 8.2 years. Three patients were randomized to the rucaparib arm and discontinued prior to receiving study drug. Reasons for discontinuation were due to withdrawal of consent, physician decision, and laboratory value (did not meet eligibility criteria)
Injury, poisoning and procedural complications Joint dislocation	0.27% 1/372 • Adverse events were reported from the date of first dose of study drug and until 28 days after last dose of study drug, approximately 8.2 years. Three patients were randomized to the rucaparib arm and discontinued prior to receiving study drug. Reasons for discontinuation were due to withdrawal of consent, physician decision, and laboratory value (did not meet eligibility criteria)	0.00% 0/189 • Adverse events were reported from the date of first dose of study drug and until 28 days after last dose of study drug, approximately 8.2 years. Three patients were randomized to the rucaparib arm and discontinued prior to receiving study drug. Reasons for discontinuation were due to withdrawal of consent, physician decision, and laboratory value (did not meet eligibility criteria)
Injury, poisoning and procedural complications Pelvic fracture	0.27% 1/372 • Adverse events were reported from the date of first dose of study drug and until 28 days after last dose of study drug, approximately 8.2 years. Three patients were randomized to the rucaparib arm and discontinued prior to receiving study drug. Reasons for discontinuation were due to withdrawal of consent, physician decision, and laboratory value (did not meet eligibility criteria)	0.00% 0/189 • Adverse events were reported from the date of first dose of study drug and until 28 days after last dose of study drug, approximately 8.2 years. Three patients were randomized to the rucaparib arm and discontinued prior to receiving study drug. Reasons for discontinuation were due to withdrawal of consent, physician decision, and laboratory value (did not meet eligibility criteria)
Injury, poisoning and procedural complications Post procedural haematoma	0.27% 1/372 • Adverse events were reported from the date of first dose of study drug and until 28 days after last dose of study drug, approximately 8.2 years. Three patients were randomized to the rucaparib arm and discontinued prior to receiving study drug. Reasons for discontinuation were due to withdrawal of consent, physician decision, and laboratory value (did not meet eligibility criteria)	0.00% 0/189 • Adverse events were reported from the date of first dose of study drug and until 28 days after last dose of study drug, approximately 8.2 years. Three patients were randomized to the rucaparib arm and discontinued prior to receiving study drug. Reasons for discontinuation were due to withdrawal of consent, physician decision, and laboratory value (did not meet eligibility criteria)
Injury, poisoning and procedural complications Seroma	0.27% 1/372 • Adverse events were reported from the date of first dose of study drug and until 28 days after last dose of study drug, approximately 8.2 years. Three patients were randomized to the rucaparib arm and discontinued prior to receiving study drug. Reasons for discontinuation were due to withdrawal of consent, physician decision, and laboratory value (did not meet eligibility criteria)	0.00% 0/189 • Adverse events were reported from the date of first dose of study drug and until 28 days after last dose of study drug, approximately 8.2 years. Three patients were randomized to the rucaparib arm and discontinued prior to receiving study drug. Reasons for discontinuation were due to withdrawal of consent, physician decision, and laboratory value (did not meet eligibility criteria)
Investigations Platelet count decreased	0.81% 3/372 • Adverse events were reported from the date of first dose of study drug and until 28 days after last dose of study drug, approximately 8.2 years. Three patients were randomized to the rucaparib arm and discontinued prior to receiving study drug. Reasons for discontinuation were due to withdrawal of consent, physician decision, and laboratory value (did not meet eligibility criteria)	0.00% 0/189 • Adverse events were reported from the date of first dose of study drug and until 28 days after last dose of study drug, approximately 8.2 years. Three patients were randomized to the rucaparib arm and discontinued prior to receiving study drug. Reasons for discontinuation were due to withdrawal of consent, physician decision, and laboratory value (did not meet eligibility criteria)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Acute lymphocytic leukaemia	0.27% 1/372 • Adverse events were reported from the date of first dose of study drug and until 28 days after last dose of study drug, approximately 8.2 years. Three patients were randomized to the rucaparib arm and discontinued prior to receiving study drug. Reasons for discontinuation were due to withdrawal of consent, physician decision, and laboratory value (did not meet eligibility criteria)	0.00% 0/189 • Adverse events were reported from the date of first dose of study drug and until 28 days after last dose of study drug, approximately 8.2 years. Three patients were randomized to the rucaparib arm and discontinued prior to receiving study drug. Reasons for discontinuation were due to withdrawal of consent, physician decision, and laboratory value (did not meet eligibility criteria)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Basal cell carcinoma	0.27% 1/372 • Adverse events were reported from the date of first dose of study drug and until 28 days after last dose of study drug, approximately 8.2 years. Three patients were randomized to the rucaparib arm and discontinued prior to receiving study drug. Reasons for discontinuation were due to withdrawal of consent, physician decision, and laboratory value (did not meet eligibility criteria)	0.00% 0/189 • Adverse events were reported from the date of first dose of study drug and until 28 days after last dose of study drug, approximately 8.2 years. Three patients were randomized to the rucaparib arm and discontinued prior to receiving study drug. Reasons for discontinuation were due to withdrawal of consent, physician decision, and laboratory value (did not meet eligibility criteria)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Invasive lobular breast carcinoma	0.27% 1/372 • Adverse events were reported from the date of first dose of study drug and until 28 days after last dose of study drug, approximately 8.2 years. Three patients were randomized to the rucaparib arm and discontinued prior to receiving study drug. Reasons for discontinuation were due to withdrawal of consent, physician decision, and laboratory value (did not meet eligibility criteria)	0.00% 0/189 • Adverse events were reported from the date of first dose of study drug and until 28 days after last dose of study drug, approximately 8.2 years. Three patients were randomized to the rucaparib arm and discontinued prior to receiving study drug. Reasons for discontinuation were due to withdrawal of consent, physician decision, and laboratory value (did not meet eligibility criteria)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung squamous cell carcinoma recurrent	0.27% 1/372 • Adverse events were reported from the date of first dose of study drug and until 28 days after last dose of study drug, approximately 8.2 years. Three patients were randomized to the rucaparib arm and discontinued prior to receiving study drug. Reasons for discontinuation were due to withdrawal of consent, physician decision, and laboratory value (did not meet eligibility criteria)	0.00% 0/189 • Adverse events were reported from the date of first dose of study drug and until 28 days after last dose of study drug, approximately 8.2 years. Three patients were randomized to the rucaparib arm and discontinued prior to receiving study drug. Reasons for discontinuation were due to withdrawal of consent, physician decision, and laboratory value (did not meet eligibility criteria)
Nervous system disorders Cerebrovascular accident	0.27% 1/372 • Adverse events were reported from the date of first dose of study drug and until 28 days after last dose of study drug, approximately 8.2 years. Three patients were randomized to the rucaparib arm and discontinued prior to receiving study drug. Reasons for discontinuation were due to withdrawal of consent, physician decision, and laboratory value (did not meet eligibility criteria)	0.00% 0/189 • Adverse events were reported from the date of first dose of study drug and until 28 days after last dose of study drug, approximately 8.2 years. Three patients were randomized to the rucaparib arm and discontinued prior to receiving study drug. Reasons for discontinuation were due to withdrawal of consent, physician decision, and laboratory value (did not meet eligibility criteria)
Psychiatric disorders Behaviour disorder	0.00% 0/372 • Adverse events were reported from the date of first dose of study drug and until 28 days after last dose of study drug, approximately 8.2 years. Three patients were randomized to the rucaparib arm and discontinued prior to receiving study drug. Reasons for discontinuation were due to withdrawal of consent, physician decision, and laboratory value (did not meet eligibility criteria)	0.53% 1/189 • Adverse events were reported from the date of first dose of study drug and until 28 days after last dose of study drug, approximately 8.2 years. Three patients were randomized to the rucaparib arm and discontinued prior to receiving study drug. Reasons for discontinuation were due to withdrawal of consent, physician decision, and laboratory value (did not meet eligibility criteria)
Respiratory, thoracic and mediastinal disorders Haemoptysis	0.27% 1/372 • Adverse events were reported from the date of first dose of study drug and until 28 days after last dose of study drug, approximately 8.2 years. Three patients were randomized to the rucaparib arm and discontinued prior to receiving study drug. Reasons for discontinuation were due to withdrawal of consent, physician decision, and laboratory value (did not meet eligibility criteria)	0.00% 0/189 • Adverse events were reported from the date of first dose of study drug and until 28 days after last dose of study drug, approximately 8.2 years. Three patients were randomized to the rucaparib arm and discontinued prior to receiving study drug. Reasons for discontinuation were due to withdrawal of consent, physician decision, and laboratory value (did not meet eligibility criteria)
Respiratory, thoracic and mediastinal disorders Hypersensitivity pneumonitis	0.27% 1/372 • Adverse events were reported from the date of first dose of study drug and until 28 days after last dose of study drug, approximately 8.2 years. Three patients were randomized to the rucaparib arm and discontinued prior to receiving study drug. Reasons for discontinuation were due to withdrawal of consent, physician decision, and laboratory value (did not meet eligibility criteria)	0.00% 0/189 • Adverse events were reported from the date of first dose of study drug and until 28 days after last dose of study drug, approximately 8.2 years. Three patients were randomized to the rucaparib arm and discontinued prior to receiving study drug. Reasons for discontinuation were due to withdrawal of consent, physician decision, and laboratory value (did not meet eligibility criteria)
Infections and infestations Respiratory syncytial virus infection	0.27% 1/372 • Adverse events were reported from the date of first dose of study drug and until 28 days after last dose of study drug, approximately 8.2 years. Three patients were randomized to the rucaparib arm and discontinued prior to receiving study drug. Reasons for discontinuation were due to withdrawal of consent, physician decision, and laboratory value (did not meet eligibility criteria)	0.00% 0/189 • Adverse events were reported from the date of first dose of study drug and until 28 days after last dose of study drug, approximately 8.2 years. Three patients were randomized to the rucaparib arm and discontinued prior to receiving study drug. Reasons for discontinuation were due to withdrawal of consent, physician decision, and laboratory value (did not meet eligibility criteria)

Other adverse events

Measure	Rucaparib 600 mg Tablets n=372 participants at risk Taken orally twice daily (continuous 28 day treatment cycles)	Placebo Tablets n=189 participants at risk Taken orally twice daily (continuous 28 day treatment cycles)
Gastrointestinal disorders Abdominal distension	13.2% 49/372 • Adverse events were reported from the date of first dose of study drug and until 28 days after last dose of study drug, approximately 8.2 years. Three patients were randomized to the rucaparib arm and discontinued prior to receiving study drug. Reasons for discontinuation were due to withdrawal of consent, physician decision, and laboratory value (did not meet eligibility criteria)	11.6% 22/189 • Adverse events were reported from the date of first dose of study drug and until 28 days after last dose of study drug, approximately 8.2 years. Three patients were randomized to the rucaparib arm and discontinued prior to receiving study drug. Reasons for discontinuation were due to withdrawal of consent, physician decision, and laboratory value (did not meet eligibility criteria)
Gastrointestinal disorders Abdominal pain	32.5% 121/372 • Adverse events were reported from the date of first dose of study drug and until 28 days after last dose of study drug, approximately 8.2 years. Three patients were randomized to the rucaparib arm and discontinued prior to receiving study drug. Reasons for discontinuation were due to withdrawal of consent, physician decision, and laboratory value (did not meet eligibility criteria)	26.5% 50/189 • Adverse events were reported from the date of first dose of study drug and until 28 days after last dose of study drug, approximately 8.2 years. Three patients were randomized to the rucaparib arm and discontinued prior to receiving study drug. Reasons for discontinuation were due to withdrawal of consent, physician decision, and laboratory value (did not meet eligibility criteria)
Gastrointestinal disorders Abdominal pain upper	15.3% 57/372 • Adverse events were reported from the date of first dose of study drug and until 28 days after last dose of study drug, approximately 8.2 years. Three patients were randomized to the rucaparib arm and discontinued prior to receiving study drug. Reasons for discontinuation were due to withdrawal of consent, physician decision, and laboratory value (did not meet eligibility criteria)	5.8% 11/189 • Adverse events were reported from the date of first dose of study drug and until 28 days after last dose of study drug, approximately 8.2 years. Three patients were randomized to the rucaparib arm and discontinued prior to receiving study drug. Reasons for discontinuation were due to withdrawal of consent, physician decision, and laboratory value (did not meet eligibility criteria)
Gastrointestinal disorders Constipation	38.4% 143/372 • Adverse events were reported from the date of first dose of study drug and until 28 days after last dose of study drug, approximately 8.2 years. Three patients were randomized to the rucaparib arm and discontinued prior to receiving study drug. Reasons for discontinuation were due to withdrawal of consent, physician decision, and laboratory value (did not meet eligibility criteria)	23.3% 44/189 • Adverse events were reported from the date of first dose of study drug and until 28 days after last dose of study drug, approximately 8.2 years. Three patients were randomized to the rucaparib arm and discontinued prior to receiving study drug. Reasons for discontinuation were due to withdrawal of consent, physician decision, and laboratory value (did not meet eligibility criteria)
Gastrointestinal disorders Diarrhoea	34.9% 130/372 • Adverse events were reported from the date of first dose of study drug and until 28 days after last dose of study drug, approximately 8.2 years. Three patients were randomized to the rucaparib arm and discontinued prior to receiving study drug. Reasons for discontinuation were due to withdrawal of consent, physician decision, and laboratory value (did not meet eligibility criteria)	22.8% 43/189 • Adverse events were reported from the date of first dose of study drug and until 28 days after last dose of study drug, approximately 8.2 years. Three patients were randomized to the rucaparib arm and discontinued prior to receiving study drug. Reasons for discontinuation were due to withdrawal of consent, physician decision, and laboratory value (did not meet eligibility criteria)
Gastrointestinal disorders Dry mouth	8.1% 30/372 • Adverse events were reported from the date of first dose of study drug and until 28 days after last dose of study drug, approximately 8.2 years. Three patients were randomized to the rucaparib arm and discontinued prior to receiving study drug. Reasons for discontinuation were due to withdrawal of consent, physician decision, and laboratory value (did not meet eligibility criteria)	4.8% 9/189 • Adverse events were reported from the date of first dose of study drug and until 28 days after last dose of study drug, approximately 8.2 years. Three patients were randomized to the rucaparib arm and discontinued prior to receiving study drug. Reasons for discontinuation were due to withdrawal of consent, physician decision, and laboratory value (did not meet eligibility criteria)
Gastrointestinal disorders Dyspepsia	15.6% 58/372 • Adverse events were reported from the date of first dose of study drug and until 28 days after last dose of study drug, approximately 8.2 years. Three patients were randomized to the rucaparib arm and discontinued prior to receiving study drug. Reasons for discontinuation were due to withdrawal of consent, physician decision, and laboratory value (did not meet eligibility criteria)	4.8% 9/189 • Adverse events were reported from the date of first dose of study drug and until 28 days after last dose of study drug, approximately 8.2 years. Three patients were randomized to the rucaparib arm and discontinued prior to receiving study drug. Reasons for discontinuation were due to withdrawal of consent, physician decision, and laboratory value (did not meet eligibility criteria)
Gastrointestinal disorders Nausea	76.3% 284/372 • Adverse events were reported from the date of first dose of study drug and until 28 days after last dose of study drug, approximately 8.2 years. Three patients were randomized to the rucaparib arm and discontinued prior to receiving study drug. Reasons for discontinuation were due to withdrawal of consent, physician decision, and laboratory value (did not meet eligibility criteria)	37.0% 70/189 • Adverse events were reported from the date of first dose of study drug and until 28 days after last dose of study drug, approximately 8.2 years. Three patients were randomized to the rucaparib arm and discontinued prior to receiving study drug. Reasons for discontinuation were due to withdrawal of consent, physician decision, and laboratory value (did not meet eligibility criteria)
Gastrointestinal disorders Stomatitis	9.4% 35/372 • Adverse events were reported from the date of first dose of study drug and until 28 days after last dose of study drug, approximately 8.2 years. Three patients were randomized to the rucaparib arm and discontinued prior to receiving study drug. Reasons for discontinuation were due to withdrawal of consent, physician decision, and laboratory value (did not meet eligibility criteria)	2.6% 5/189 • Adverse events were reported from the date of first dose of study drug and until 28 days after last dose of study drug, approximately 8.2 years. Three patients were randomized to the rucaparib arm and discontinued prior to receiving study drug. Reasons for discontinuation were due to withdrawal of consent, physician decision, and laboratory value (did not meet eligibility criteria)
Gastrointestinal disorders Vomiting	37.6% 140/372 • Adverse events were reported from the date of first dose of study drug and until 28 days after last dose of study drug, approximately 8.2 years. Three patients were randomized to the rucaparib arm and discontinued prior to receiving study drug. Reasons for discontinuation were due to withdrawal of consent, physician decision, and laboratory value (did not meet eligibility criteria)	15.3% 29/189 • Adverse events were reported from the date of first dose of study drug and until 28 days after last dose of study drug, approximately 8.2 years. Three patients were randomized to the rucaparib arm and discontinued prior to receiving study drug. Reasons for discontinuation were due to withdrawal of consent, physician decision, and laboratory value (did not meet eligibility criteria)
General disorders Mucosal inflammation	9.1% 34/372 • Adverse events were reported from the date of first dose of study drug and until 28 days after last dose of study drug, approximately 8.2 years. Three patients were randomized to the rucaparib arm and discontinued prior to receiving study drug. Reasons for discontinuation were due to withdrawal of consent, physician decision, and laboratory value (did not meet eligibility criteria)	4.8% 9/189 • Adverse events were reported from the date of first dose of study drug and until 28 days after last dose of study drug, approximately 8.2 years. Three patients were randomized to the rucaparib arm and discontinued prior to receiving study drug. Reasons for discontinuation were due to withdrawal of consent, physician decision, and laboratory value (did not meet eligibility criteria)
General disorders Oedema peripheral	11.6% 43/372 • Adverse events were reported from the date of first dose of study drug and until 28 days after last dose of study drug, approximately 8.2 years. Three patients were randomized to the rucaparib arm and discontinued prior to receiving study drug. Reasons for discontinuation were due to withdrawal of consent, physician decision, and laboratory value (did not meet eligibility criteria)	8.5% 16/189 • Adverse events were reported from the date of first dose of study drug and until 28 days after last dose of study drug, approximately 8.2 years. Three patients were randomized to the rucaparib arm and discontinued prior to receiving study drug. Reasons for discontinuation were due to withdrawal of consent, physician decision, and laboratory value (did not meet eligibility criteria)
General disorders Pyrexia	14.5% 54/372 • Adverse events were reported from the date of first dose of study drug and until 28 days after last dose of study drug, approximately 8.2 years. Three patients were randomized to the rucaparib arm and discontinued prior to receiving study drug. Reasons for discontinuation were due to withdrawal of consent, physician decision, and laboratory value (did not meet eligibility criteria)	4.8% 9/189 • Adverse events were reported from the date of first dose of study drug and until 28 days after last dose of study drug, approximately 8.2 years. Three patients were randomized to the rucaparib arm and discontinued prior to receiving study drug. Reasons for discontinuation were due to withdrawal of consent, physician decision, and laboratory value (did not meet eligibility criteria)
Infections and infestations Influenza	8.6% 32/372 • Adverse events were reported from the date of first dose of study drug and until 28 days after last dose of study drug, approximately 8.2 years. Three patients were randomized to the rucaparib arm and discontinued prior to receiving study drug. Reasons for discontinuation were due to withdrawal of consent, physician decision, and laboratory value (did not meet eligibility criteria)	2.1% 4/189 • Adverse events were reported from the date of first dose of study drug and until 28 days after last dose of study drug, approximately 8.2 years. Three patients were randomized to the rucaparib arm and discontinued prior to receiving study drug. Reasons for discontinuation were due to withdrawal of consent, physician decision, and laboratory value (did not meet eligibility criteria)
Infections and infestations Nasopharyngitis	10.2% 38/372 • Adverse events were reported from the date of first dose of study drug and until 28 days after last dose of study drug, approximately 8.2 years. Three patients were randomized to the rucaparib arm and discontinued prior to receiving study drug. Reasons for discontinuation were due to withdrawal of consent, physician decision, and laboratory value (did not meet eligibility criteria)	6.3% 12/189 • Adverse events were reported from the date of first dose of study drug and until 28 days after last dose of study drug, approximately 8.2 years. Three patients were randomized to the rucaparib arm and discontinued prior to receiving study drug. Reasons for discontinuation were due to withdrawal of consent, physician decision, and laboratory value (did not meet eligibility criteria)
Infections and infestations Sinusitis	5.4% 20/372 • Adverse events were reported from the date of first dose of study drug and until 28 days after last dose of study drug, approximately 8.2 years. Three patients were randomized to the rucaparib arm and discontinued prior to receiving study drug. Reasons for discontinuation were due to withdrawal of consent, physician decision, and laboratory value (did not meet eligibility criteria)	1.6% 3/189 • Adverse events were reported from the date of first dose of study drug and until 28 days after last dose of study drug, approximately 8.2 years. Three patients were randomized to the rucaparib arm and discontinued prior to receiving study drug. Reasons for discontinuation were due to withdrawal of consent, physician decision, and laboratory value (did not meet eligibility criteria)
Infections and infestations Upper respiratory tract infection	12.9% 48/372 • Adverse events were reported from the date of first dose of study drug and until 28 days after last dose of study drug, approximately 8.2 years. Three patients were randomized to the rucaparib arm and discontinued prior to receiving study drug. Reasons for discontinuation were due to withdrawal of consent, physician decision, and laboratory value (did not meet eligibility criteria)	3.2% 6/189 • Adverse events were reported from the date of first dose of study drug and until 28 days after last dose of study drug, approximately 8.2 years. Three patients were randomized to the rucaparib arm and discontinued prior to receiving study drug. Reasons for discontinuation were due to withdrawal of consent, physician decision, and laboratory value (did not meet eligibility criteria)
Infections and infestations Urinary tract infection	10.5% 39/372 • Adverse events were reported from the date of first dose of study drug and until 28 days after last dose of study drug, approximately 8.2 years. Three patients were randomized to the rucaparib arm and discontinued prior to receiving study drug. Reasons for discontinuation were due to withdrawal of consent, physician decision, and laboratory value (did not meet eligibility criteria)	4.8% 9/189 • Adverse events were reported from the date of first dose of study drug and until 28 days after last dose of study drug, approximately 8.2 years. Three patients were randomized to the rucaparib arm and discontinued prior to receiving study drug. Reasons for discontinuation were due to withdrawal of consent, physician decision, and laboratory value (did not meet eligibility criteria)
Investigations Blood alkaline phosphatase increased	5.9% 22/372 • Adverse events were reported from the date of first dose of study drug and until 28 days after last dose of study drug, approximately 8.2 years. Three patients were randomized to the rucaparib arm and discontinued prior to receiving study drug. Reasons for discontinuation were due to withdrawal of consent, physician decision, and laboratory value (did not meet eligibility criteria)	0.53% 1/189 • Adverse events were reported from the date of first dose of study drug and until 28 days after last dose of study drug, approximately 8.2 years. Three patients were randomized to the rucaparib arm and discontinued prior to receiving study drug. Reasons for discontinuation were due to withdrawal of consent, physician decision, and laboratory value (did not meet eligibility criteria)
Investigations Blood creatinine increased	17.2% 64/372 • Adverse events were reported from the date of first dose of study drug and until 28 days after last dose of study drug, approximately 8.2 years. Three patients were randomized to the rucaparib arm and discontinued prior to receiving study drug. Reasons for discontinuation were due to withdrawal of consent, physician decision, and laboratory value (did not meet eligibility criteria)	1.6% 3/189 • Adverse events were reported from the date of first dose of study drug and until 28 days after last dose of study drug, approximately 8.2 years. Three patients were randomized to the rucaparib arm and discontinued prior to receiving study drug. Reasons for discontinuation were due to withdrawal of consent, physician decision, and laboratory value (did not meet eligibility criteria)
Investigations Weight decreased	8.1% 30/372 • Adverse events were reported from the date of first dose of study drug and until 28 days after last dose of study drug, approximately 8.2 years. Three patients were randomized to the rucaparib arm and discontinued prior to receiving study drug. Reasons for discontinuation were due to withdrawal of consent, physician decision, and laboratory value (did not meet eligibility criteria)	1.6% 3/189 • Adverse events were reported from the date of first dose of study drug and until 28 days after last dose of study drug, approximately 8.2 years. Three patients were randomized to the rucaparib arm and discontinued prior to receiving study drug. Reasons for discontinuation were due to withdrawal of consent, physician decision, and laboratory value (did not meet eligibility criteria)
Investigations White blood cell count decreased	7.0% 26/372 • Adverse events were reported from the date of first dose of study drug and until 28 days after last dose of study drug, approximately 8.2 years. Three patients were randomized to the rucaparib arm and discontinued prior to receiving study drug. Reasons for discontinuation were due to withdrawal of consent, physician decision, and laboratory value (did not meet eligibility criteria)	4.2% 8/189 • Adverse events were reported from the date of first dose of study drug and until 28 days after last dose of study drug, approximately 8.2 years. Three patients were randomized to the rucaparib arm and discontinued prior to receiving study drug. Reasons for discontinuation were due to withdrawal of consent, physician decision, and laboratory value (did not meet eligibility criteria)
Metabolism and nutrition disorders Decreased appetite	25.3% 94/372 • Adverse events were reported from the date of first dose of study drug and until 28 days after last dose of study drug, approximately 8.2 years. Three patients were randomized to the rucaparib arm and discontinued prior to receiving study drug. Reasons for discontinuation were due to withdrawal of consent, physician decision, and laboratory value (did not meet eligibility criteria)	13.2% 25/189 • Adverse events were reported from the date of first dose of study drug and until 28 days after last dose of study drug, approximately 8.2 years. Three patients were randomized to the rucaparib arm and discontinued prior to receiving study drug. Reasons for discontinuation were due to withdrawal of consent, physician decision, and laboratory value (did not meet eligibility criteria)
Metabolism and nutrition disorders Hypercholesterolaemia	7.5% 28/372 • Adverse events were reported from the date of first dose of study drug and until 28 days after last dose of study drug, approximately 8.2 years. Three patients were randomized to the rucaparib arm and discontinued prior to receiving study drug. Reasons for discontinuation were due to withdrawal of consent, physician decision, and laboratory value (did not meet eligibility criteria)	2.1% 4/189 • Adverse events were reported from the date of first dose of study drug and until 28 days after last dose of study drug, approximately 8.2 years. Three patients were randomized to the rucaparib arm and discontinued prior to receiving study drug. Reasons for discontinuation were due to withdrawal of consent, physician decision, and laboratory value (did not meet eligibility criteria)
Metabolism and nutrition disorders Hypomagnesaemia	11.8% 44/372 • Adverse events were reported from the date of first dose of study drug and until 28 days after last dose of study drug, approximately 8.2 years. Three patients were randomized to the rucaparib arm and discontinued prior to receiving study drug. Reasons for discontinuation were due to withdrawal of consent, physician decision, and laboratory value (did not meet eligibility criteria)	5.8% 11/189 • Adverse events were reported from the date of first dose of study drug and until 28 days after last dose of study drug, approximately 8.2 years. Three patients were randomized to the rucaparib arm and discontinued prior to receiving study drug. Reasons for discontinuation were due to withdrawal of consent, physician decision, and laboratory value (did not meet eligibility criteria)
Musculoskeletal and connective tissue disorders Arthralgia	21.8% 81/372 • Adverse events were reported from the date of first dose of study drug and until 28 days after last dose of study drug, approximately 8.2 years. Three patients were randomized to the rucaparib arm and discontinued prior to receiving study drug. Reasons for discontinuation were due to withdrawal of consent, physician decision, and laboratory value (did not meet eligibility criteria)	14.3% 27/189 • Adverse events were reported from the date of first dose of study drug and until 28 days after last dose of study drug, approximately 8.2 years. Three patients were randomized to the rucaparib arm and discontinued prior to receiving study drug. Reasons for discontinuation were due to withdrawal of consent, physician decision, and laboratory value (did not meet eligibility criteria)
Musculoskeletal and connective tissue disorders Back pain	15.3% 57/372 • Adverse events were reported from the date of first dose of study drug and until 28 days after last dose of study drug, approximately 8.2 years. Three patients were randomized to the rucaparib arm and discontinued prior to receiving study drug. Reasons for discontinuation were due to withdrawal of consent, physician decision, and laboratory value (did not meet eligibility criteria)	13.8% 26/189 • Adverse events were reported from the date of first dose of study drug and until 28 days after last dose of study drug, approximately 8.2 years. Three patients were randomized to the rucaparib arm and discontinued prior to receiving study drug. Reasons for discontinuation were due to withdrawal of consent, physician decision, and laboratory value (did not meet eligibility criteria)
Musculoskeletal and connective tissue disorders Muscle spasms	4.6% 17/372 • Adverse events were reported from the date of first dose of study drug and until 28 days after last dose of study drug, approximately 8.2 years. Three patients were randomized to the rucaparib arm and discontinued prior to receiving study drug. Reasons for discontinuation were due to withdrawal of consent, physician decision, and laboratory value (did not meet eligibility criteria)	7.9% 15/189 • Adverse events were reported from the date of first dose of study drug and until 28 days after last dose of study drug, approximately 8.2 years. Three patients were randomized to the rucaparib arm and discontinued prior to receiving study drug. Reasons for discontinuation were due to withdrawal of consent, physician decision, and laboratory value (did not meet eligibility criteria)
Musculoskeletal and connective tissue disorders Myalgia	6.7% 25/372 • Adverse events were reported from the date of first dose of study drug and until 28 days after last dose of study drug, approximately 8.2 years. Three patients were randomized to the rucaparib arm and discontinued prior to receiving study drug. Reasons for discontinuation were due to withdrawal of consent, physician decision, and laboratory value (did not meet eligibility criteria)	3.7% 7/189 • Adverse events were reported from the date of first dose of study drug and until 28 days after last dose of study drug, approximately 8.2 years. Three patients were randomized to the rucaparib arm and discontinued prior to receiving study drug. Reasons for discontinuation were due to withdrawal of consent, physician decision, and laboratory value (did not meet eligibility criteria)
Musculoskeletal and connective tissue disorders Pain in extremity	5.6% 21/372 • Adverse events were reported from the date of first dose of study drug and until 28 days after last dose of study drug, approximately 8.2 years. Three patients were randomized to the rucaparib arm and discontinued prior to receiving study drug. Reasons for discontinuation were due to withdrawal of consent, physician decision, and laboratory value (did not meet eligibility criteria)	9.0% 17/189 • Adverse events were reported from the date of first dose of study drug and until 28 days after last dose of study drug, approximately 8.2 years. Three patients were randomized to the rucaparib arm and discontinued prior to receiving study drug. Reasons for discontinuation were due to withdrawal of consent, physician decision, and laboratory value (did not meet eligibility criteria)
Nervous system disorders Dizziness	16.4% 61/372 • Adverse events were reported from the date of first dose of study drug and until 28 days after last dose of study drug, approximately 8.2 years. Three patients were randomized to the rucaparib arm and discontinued prior to receiving study drug. Reasons for discontinuation were due to withdrawal of consent, physician decision, and laboratory value (did not meet eligibility criteria)	7.9% 15/189 • Adverse events were reported from the date of first dose of study drug and until 28 days after last dose of study drug, approximately 8.2 years. Three patients were randomized to the rucaparib arm and discontinued prior to receiving study drug. Reasons for discontinuation were due to withdrawal of consent, physician decision, and laboratory value (did not meet eligibility criteria)
Nervous system disorders Dysgeusia	30.6% 114/372 • Adverse events were reported from the date of first dose of study drug and until 28 days after last dose of study drug, approximately 8.2 years. Three patients were randomized to the rucaparib arm and discontinued prior to receiving study drug. Reasons for discontinuation were due to withdrawal of consent, physician decision, and laboratory value (did not meet eligibility criteria)	5.8% 11/189 • Adverse events were reported from the date of first dose of study drug and until 28 days after last dose of study drug, approximately 8.2 years. Three patients were randomized to the rucaparib arm and discontinued prior to receiving study drug. Reasons for discontinuation were due to withdrawal of consent, physician decision, and laboratory value (did not meet eligibility criteria)
Nervous system disorders Headache	19.9% 74/372 • Adverse events were reported from the date of first dose of study drug and until 28 days after last dose of study drug, approximately 8.2 years. Three patients were randomized to the rucaparib arm and discontinued prior to receiving study drug. Reasons for discontinuation were due to withdrawal of consent, physician decision, and laboratory value (did not meet eligibility criteria)	16.4% 31/189 • Adverse events were reported from the date of first dose of study drug and until 28 days after last dose of study drug, approximately 8.2 years. Three patients were randomized to the rucaparib arm and discontinued prior to receiving study drug. Reasons for discontinuation were due to withdrawal of consent, physician decision, and laboratory value (did not meet eligibility criteria)
Psychiatric disorders Anxiety	8.3% 31/372 • Adverse events were reported from the date of first dose of study drug and until 28 days after last dose of study drug, approximately 8.2 years. Three patients were randomized to the rucaparib arm and discontinued prior to receiving study drug. Reasons for discontinuation were due to withdrawal of consent, physician decision, and laboratory value (did not meet eligibility criteria)	7.4% 14/189 • Adverse events were reported from the date of first dose of study drug and until 28 days after last dose of study drug, approximately 8.2 years. Three patients were randomized to the rucaparib arm and discontinued prior to receiving study drug. Reasons for discontinuation were due to withdrawal of consent, physician decision, and laboratory value (did not meet eligibility criteria)
Psychiatric disorders Depression	8.9% 33/372 • Adverse events were reported from the date of first dose of study drug and until 28 days after last dose of study drug, approximately 8.2 years. Three patients were randomized to the rucaparib arm and discontinued prior to receiving study drug. Reasons for discontinuation were due to withdrawal of consent, physician decision, and laboratory value (did not meet eligibility criteria)	3.2% 6/189 • Adverse events were reported from the date of first dose of study drug and until 28 days after last dose of study drug, approximately 8.2 years. Three patients were randomized to the rucaparib arm and discontinued prior to receiving study drug. Reasons for discontinuation were due to withdrawal of consent, physician decision, and laboratory value (did not meet eligibility criteria)
Psychiatric disorders Insomnia	15.6% 58/372 • Adverse events were reported from the date of first dose of study drug and until 28 days after last dose of study drug, approximately 8.2 years. Three patients were randomized to the rucaparib arm and discontinued prior to receiving study drug. Reasons for discontinuation were due to withdrawal of consent, physician decision, and laboratory value (did not meet eligibility criteria)	7.9% 15/189 • Adverse events were reported from the date of first dose of study drug and until 28 days after last dose of study drug, approximately 8.2 years. Three patients were randomized to the rucaparib arm and discontinued prior to receiving study drug. Reasons for discontinuation were due to withdrawal of consent, physician decision, and laboratory value (did not meet eligibility criteria)
Respiratory, thoracic and mediastinal disorders Cough	18.0% 67/372 • Adverse events were reported from the date of first dose of study drug and until 28 days after last dose of study drug, approximately 8.2 years. Three patients were randomized to the rucaparib arm and discontinued prior to receiving study drug. Reasons for discontinuation were due to withdrawal of consent, physician decision, and laboratory value (did not meet eligibility criteria)	13.2% 25/189 • Adverse events were reported from the date of first dose of study drug and until 28 days after last dose of study drug, approximately 8.2 years. Three patients were randomized to the rucaparib arm and discontinued prior to receiving study drug. Reasons for discontinuation were due to withdrawal of consent, physician decision, and laboratory value (did not meet eligibility criteria)
Respiratory, thoracic and mediastinal disorders Dyspnoea	15.3% 57/372 • Adverse events were reported from the date of first dose of study drug and until 28 days after last dose of study drug, approximately 8.2 years. Three patients were randomized to the rucaparib arm and discontinued prior to receiving study drug. Reasons for discontinuation were due to withdrawal of consent, physician decision, and laboratory value (did not meet eligibility criteria)	7.4% 14/189 • Adverse events were reported from the date of first dose of study drug and until 28 days after last dose of study drug, approximately 8.2 years. Three patients were randomized to the rucaparib arm and discontinued prior to receiving study drug. Reasons for discontinuation were due to withdrawal of consent, physician decision, and laboratory value (did not meet eligibility criteria)
Skin and subcutaneous tissue disorders Alopecia	9.7% 36/372 • Adverse events were reported from the date of first dose of study drug and until 28 days after last dose of study drug, approximately 8.2 years. Three patients were randomized to the rucaparib arm and discontinued prior to receiving study drug. Reasons for discontinuation were due to withdrawal of consent, physician decision, and laboratory value (did not meet eligibility criteria)	6.9% 13/189 • Adverse events were reported from the date of first dose of study drug and until 28 days after last dose of study drug, approximately 8.2 years. Three patients were randomized to the rucaparib arm and discontinued prior to receiving study drug. Reasons for discontinuation were due to withdrawal of consent, physician decision, and laboratory value (did not meet eligibility criteria)
Skin and subcutaneous tissue disorders Dry skin	10.5% 39/372 • Adverse events were reported from the date of first dose of study drug and until 28 days after last dose of study drug, approximately 8.2 years. Three patients were randomized to the rucaparib arm and discontinued prior to receiving study drug. Reasons for discontinuation were due to withdrawal of consent, physician decision, and laboratory value (did not meet eligibility criteria)	8.5% 16/189 • Adverse events were reported from the date of first dose of study drug and until 28 days after last dose of study drug, approximately 8.2 years. Three patients were randomized to the rucaparib arm and discontinued prior to receiving study drug. Reasons for discontinuation were due to withdrawal of consent, physician decision, and laboratory value (did not meet eligibility criteria)
Skin and subcutaneous tissue disorders Erythema	8.6% 32/372 • Adverse events were reported from the date of first dose of study drug and until 28 days after last dose of study drug, approximately 8.2 years. Three patients were randomized to the rucaparib arm and discontinued prior to receiving study drug. Reasons for discontinuation were due to withdrawal of consent, physician decision, and laboratory value (did not meet eligibility criteria)	2.6% 5/189 • Adverse events were reported from the date of first dose of study drug and until 28 days after last dose of study drug, approximately 8.2 years. Three patients were randomized to the rucaparib arm and discontinued prior to receiving study drug. Reasons for discontinuation were due to withdrawal of consent, physician decision, and laboratory value (did not meet eligibility criteria)
Skin and subcutaneous tissue disorders Photosensitivity reaction	18.5% 69/372 • Adverse events were reported from the date of first dose of study drug and until 28 days after last dose of study drug, approximately 8.2 years. Three patients were randomized to the rucaparib arm and discontinued prior to receiving study drug. Reasons for discontinuation were due to withdrawal of consent, physician decision, and laboratory value (did not meet eligibility criteria)	0.53% 1/189 • Adverse events were reported from the date of first dose of study drug and until 28 days after last dose of study drug, approximately 8.2 years. Three patients were randomized to the rucaparib arm and discontinued prior to receiving study drug. Reasons for discontinuation were due to withdrawal of consent, physician decision, and laboratory value (did not meet eligibility criteria)
Skin and subcutaneous tissue disorders Pruritus	14.5% 54/372 • Adverse events were reported from the date of first dose of study drug and until 28 days after last dose of study drug, approximately 8.2 years. Three patients were randomized to the rucaparib arm and discontinued prior to receiving study drug. Reasons for discontinuation were due to withdrawal of consent, physician decision, and laboratory value (did not meet eligibility criteria)	11.6% 22/189 • Adverse events were reported from the date of first dose of study drug and until 28 days after last dose of study drug, approximately 8.2 years. Three patients were randomized to the rucaparib arm and discontinued prior to receiving study drug. Reasons for discontinuation were due to withdrawal of consent, physician decision, and laboratory value (did not meet eligibility criteria)
Skin and subcutaneous tissue disorders Rash	14.5% 54/372 • Adverse events were reported from the date of first dose of study drug and until 28 days after last dose of study drug, approximately 8.2 years. Three patients were randomized to the rucaparib arm and discontinued prior to receiving study drug. Reasons for discontinuation were due to withdrawal of consent, physician decision, and laboratory value (did not meet eligibility criteria)	9.0% 17/189 • Adverse events were reported from the date of first dose of study drug and until 28 days after last dose of study drug, approximately 8.2 years. Three patients were randomized to the rucaparib arm and discontinued prior to receiving study drug. Reasons for discontinuation were due to withdrawal of consent, physician decision, and laboratory value (did not meet eligibility criteria)
Vascular disorders Hot flush	6.2% 23/372 • Adverse events were reported from the date of first dose of study drug and until 28 days after last dose of study drug, approximately 8.2 years. Three patients were randomized to the rucaparib arm and discontinued prior to receiving study drug. Reasons for discontinuation were due to withdrawal of consent, physician decision, and laboratory value (did not meet eligibility criteria)	4.2% 8/189 • Adverse events were reported from the date of first dose of study drug and until 28 days after last dose of study drug, approximately 8.2 years. Three patients were randomized to the rucaparib arm and discontinued prior to receiving study drug. Reasons for discontinuation were due to withdrawal of consent, physician decision, and laboratory value (did not meet eligibility criteria)
Vascular disorders Hypertension	11.6% 43/372 • Adverse events were reported from the date of first dose of study drug and until 28 days after last dose of study drug, approximately 8.2 years. Three patients were randomized to the rucaparib arm and discontinued prior to receiving study drug. Reasons for discontinuation were due to withdrawal of consent, physician decision, and laboratory value (did not meet eligibility criteria)	8.5% 16/189 • Adverse events were reported from the date of first dose of study drug and until 28 days after last dose of study drug, approximately 8.2 years. Three patients were randomized to the rucaparib arm and discontinued prior to receiving study drug. Reasons for discontinuation were due to withdrawal of consent, physician decision, and laboratory value (did not meet eligibility criteria)
Blood and lymphatic system disorders Anaemia	37.4% 139/372 • Adverse events were reported from the date of first dose of study drug and until 28 days after last dose of study drug, approximately 8.2 years. Three patients were randomized to the rucaparib arm and discontinued prior to receiving study drug. Reasons for discontinuation were due to withdrawal of consent, physician decision, and laboratory value (did not meet eligibility criteria)	4.8% 9/189 • Adverse events were reported from the date of first dose of study drug and until 28 days after last dose of study drug, approximately 8.2 years. Three patients were randomized to the rucaparib arm and discontinued prior to receiving study drug. Reasons for discontinuation were due to withdrawal of consent, physician decision, and laboratory value (did not meet eligibility criteria)
Blood and lymphatic system disorders Neutropenia	13.7% 51/372 • Adverse events were reported from the date of first dose of study drug and until 28 days after last dose of study drug, approximately 8.2 years. Three patients were randomized to the rucaparib arm and discontinued prior to receiving study drug. Reasons for discontinuation were due to withdrawal of consent, physician decision, and laboratory value (did not meet eligibility criteria)	1.6% 3/189 • Adverse events were reported from the date of first dose of study drug and until 28 days after last dose of study drug, approximately 8.2 years. Three patients were randomized to the rucaparib arm and discontinued prior to receiving study drug. Reasons for discontinuation were due to withdrawal of consent, physician decision, and laboratory value (did not meet eligibility criteria)
Blood and lymphatic system disorders Thrombocytopenia	17.5% 65/372 • Adverse events were reported from the date of first dose of study drug and until 28 days after last dose of study drug, approximately 8.2 years. Three patients were randomized to the rucaparib arm and discontinued prior to receiving study drug. Reasons for discontinuation were due to withdrawal of consent, physician decision, and laboratory value (did not meet eligibility criteria)	1.1% 2/189 • Adverse events were reported from the date of first dose of study drug and until 28 days after last dose of study drug, approximately 8.2 years. Three patients were randomized to the rucaparib arm and discontinued prior to receiving study drug. Reasons for discontinuation were due to withdrawal of consent, physician decision, and laboratory value (did not meet eligibility criteria)
Gastrointestinal disorders Gastrooesophageal reflux disease	5.6% 21/372 • Adverse events were reported from the date of first dose of study drug and until 28 days after last dose of study drug, approximately 8.2 years. Three patients were randomized to the rucaparib arm and discontinued prior to receiving study drug. Reasons for discontinuation were due to withdrawal of consent, physician decision, and laboratory value (did not meet eligibility criteria)	3.7% 7/189 • Adverse events were reported from the date of first dose of study drug and until 28 days after last dose of study drug, approximately 8.2 years. Three patients were randomized to the rucaparib arm and discontinued prior to receiving study drug. Reasons for discontinuation were due to withdrawal of consent, physician decision, and laboratory value (did not meet eligibility criteria)
General disorders Asthenia	23.4% 87/372 • Adverse events were reported from the date of first dose of study drug and until 28 days after last dose of study drug, approximately 8.2 years. Three patients were randomized to the rucaparib arm and discontinued prior to receiving study drug. Reasons for discontinuation were due to withdrawal of consent, physician decision, and laboratory value (did not meet eligibility criteria)	10.6% 20/189 • Adverse events were reported from the date of first dose of study drug and until 28 days after last dose of study drug, approximately 8.2 years. Three patients were randomized to the rucaparib arm and discontinued prior to receiving study drug. Reasons for discontinuation were due to withdrawal of consent, physician decision, and laboratory value (did not meet eligibility criteria)
General disorders Fatigue	51.6% 192/372 • Adverse events were reported from the date of first dose of study drug and until 28 days after last dose of study drug, approximately 8.2 years. Three patients were randomized to the rucaparib arm and discontinued prior to receiving study drug. Reasons for discontinuation were due to withdrawal of consent, physician decision, and laboratory value (did not meet eligibility criteria)	34.9% 66/189 • Adverse events were reported from the date of first dose of study drug and until 28 days after last dose of study drug, approximately 8.2 years. Three patients were randomized to the rucaparib arm and discontinued prior to receiving study drug. Reasons for discontinuation were due to withdrawal of consent, physician decision, and laboratory value (did not meet eligibility criteria)
General disorders Influenza like illness	5.9% 22/372 • Adverse events were reported from the date of first dose of study drug and until 28 days after last dose of study drug, approximately 8.2 years. Three patients were randomized to the rucaparib arm and discontinued prior to receiving study drug. Reasons for discontinuation were due to withdrawal of consent, physician decision, and laboratory value (did not meet eligibility criteria)	1.1% 2/189 • Adverse events were reported from the date of first dose of study drug and until 28 days after last dose of study drug, approximately 8.2 years. Three patients were randomized to the rucaparib arm and discontinued prior to receiving study drug. Reasons for discontinuation were due to withdrawal of consent, physician decision, and laboratory value (did not meet eligibility criteria)
Investigations Alanine aminotransferase increased	34.7% 129/372 • Adverse events were reported from the date of first dose of study drug and until 28 days after last dose of study drug, approximately 8.2 years. Three patients were randomized to the rucaparib arm and discontinued prior to receiving study drug. Reasons for discontinuation were due to withdrawal of consent, physician decision, and laboratory value (did not meet eligibility criteria)	2.1% 4/189 • Adverse events were reported from the date of first dose of study drug and until 28 days after last dose of study drug, approximately 8.2 years. Three patients were randomized to the rucaparib arm and discontinued prior to receiving study drug. Reasons for discontinuation were due to withdrawal of consent, physician decision, and laboratory value (did not meet eligibility criteria)
Investigations Aspartate aminotransferase increased	27.4% 102/372 • Adverse events were reported from the date of first dose of study drug and until 28 days after last dose of study drug, approximately 8.2 years. Three patients were randomized to the rucaparib arm and discontinued prior to receiving study drug. Reasons for discontinuation were due to withdrawal of consent, physician decision, and laboratory value (did not meet eligibility criteria)	1.6% 3/189 • Adverse events were reported from the date of first dose of study drug and until 28 days after last dose of study drug, approximately 8.2 years. Three patients were randomized to the rucaparib arm and discontinued prior to receiving study drug. Reasons for discontinuation were due to withdrawal of consent, physician decision, and laboratory value (did not meet eligibility criteria)
Investigations Neutrophil count decreased	8.3% 31/372 • Adverse events were reported from the date of first dose of study drug and until 28 days after last dose of study drug, approximately 8.2 years. Three patients were randomized to the rucaparib arm and discontinued prior to receiving study drug. Reasons for discontinuation were due to withdrawal of consent, physician decision, and laboratory value (did not meet eligibility criteria)	3.2% 6/189 • Adverse events were reported from the date of first dose of study drug and until 28 days after last dose of study drug, approximately 8.2 years. Three patients were randomized to the rucaparib arm and discontinued prior to receiving study drug. Reasons for discontinuation were due to withdrawal of consent, physician decision, and laboratory value (did not meet eligibility criteria)
Investigations Platelet count decreased	14.0% 52/372 • Adverse events were reported from the date of first dose of study drug and until 28 days after last dose of study drug, approximately 8.2 years. Three patients were randomized to the rucaparib arm and discontinued prior to receiving study drug. Reasons for discontinuation were due to withdrawal of consent, physician decision, and laboratory value (did not meet eligibility criteria)	1.6% 3/189 • Adverse events were reported from the date of first dose of study drug and until 28 days after last dose of study drug, approximately 8.2 years. Three patients were randomized to the rucaparib arm and discontinued prior to receiving study drug. Reasons for discontinuation were due to withdrawal of consent, physician decision, and laboratory value (did not meet eligibility criteria)
Musculoskeletal and connective tissue disorders Neck pain	5.6% 21/372 • Adverse events were reported from the date of first dose of study drug and until 28 days after last dose of study drug, approximately 8.2 years. Three patients were randomized to the rucaparib arm and discontinued prior to receiving study drug. Reasons for discontinuation were due to withdrawal of consent, physician decision, and laboratory value (did not meet eligibility criteria)	2.6% 5/189 • Adverse events were reported from the date of first dose of study drug and until 28 days after last dose of study drug, approximately 8.2 years. Three patients were randomized to the rucaparib arm and discontinued prior to receiving study drug. Reasons for discontinuation were due to withdrawal of consent, physician decision, and laboratory value (did not meet eligibility criteria)
Nervous system disorders Taste disorder	10.2% 38/372 • Adverse events were reported from the date of first dose of study drug and until 28 days after last dose of study drug, approximately 8.2 years. Three patients were randomized to the rucaparib arm and discontinued prior to receiving study drug. Reasons for discontinuation were due to withdrawal of consent, physician decision, and laboratory value (did not meet eligibility criteria)	1.1% 2/189 • Adverse events were reported from the date of first dose of study drug and until 28 days after last dose of study drug, approximately 8.2 years. Three patients were randomized to the rucaparib arm and discontinued prior to receiving study drug. Reasons for discontinuation were due to withdrawal of consent, physician decision, and laboratory value (did not meet eligibility criteria)
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	7.0% 26/372 • Adverse events were reported from the date of first dose of study drug and until 28 days after last dose of study drug, approximately 8.2 years. Three patients were randomized to the rucaparib arm and discontinued prior to receiving study drug. Reasons for discontinuation were due to withdrawal of consent, physician decision, and laboratory value (did not meet eligibility criteria)	3.7% 7/189 • Adverse events were reported from the date of first dose of study drug and until 28 days after last dose of study drug, approximately 8.2 years. Three patients were randomized to the rucaparib arm and discontinued prior to receiving study drug. Reasons for discontinuation were due to withdrawal of consent, physician decision, and laboratory value (did not meet eligibility criteria)

Additional Information

Medical Information Department

Clovis Oncology, Inc.

Phone: +1 415 409 7220

Email: medinfo@clovisoncology.com

Results disclosure agreements

• Principal investigator is a sponsor employee Sponsor's agreements with investigators require proposed public disclosures of trial results to be submitted to Sponsor for review prior to publication. Sponsor may request deletion of confidential information or a delay in publication to address intellectual property concerns, but Sponsor may not suppress publication of the trial results indefinitely. Sponsor may request delay of a single-center publication until after the release of a multi-site publication or an agreed upon period of time.
• Publication restrictions are in place

Restriction type: OTHER