Trial Outcomes & Findings for A Study of Rucaparib in Patients With Metastatic Castration-resistant Prostate Cancer and Homologous Recombination Gene Deficiency (NCT NCT02952534)

Last Updated: 2023-06-09

Results Overview

The primary efficacy endpoint is confirmed radiographic ORR by central IRR. ORR is defined as the percentage of patients with a confirmed CR (complete response) or PR (partial response) by mRECIST (modified Response Evaluation Criteria in Solid Tumors) v1.1/PCWG3 (Prostate Cancer Working Group 3) criteria. The confirmed response is defined as a CR or PR on subsequent tumor assessment at least 28 days after first response documentation in the absence of confirmed progression in bone. CR is disappearance of all target and non-target lesions; any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm. PR is at least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

277 participants

Primary outcome timeframe

Assessments every 8 weeks from study day 1 for the first 24 weeks, and then every 12 weeks until disease progression, death, or initiation of subsequent treatment. Total follow-up was up to approximately 3 years.

Results posted on

2023-06-09

Participant Flow

A total of 277 patients were recruited from 102 sites across 12 countries.

Participant milestones

Participant milestones
Measure	BRCA Mutation Patients with a deleterious BRCA (breast cancer susceptibility gene) mutation detected in their tumor.	ATM Mutation Patients with a deleterious ATM (ataxia telangiectasia mutated serine/threonine kinase) mutation detected in their tumor.	CDK12 Mutation Patients with a deleterious CDK12 (Cyclin-dependent kinase 12) mutation detected in their tumor.	CHEK2 Mutation Patients with a deleterious CHEK2 (Checkpoint Kinase 2) mutation detected in their tumor.	Other Gene Mutation Patients with other deleterious HRR (homologous recombination repair) gene mutation detected in their tumor.
Overall Study STARTED	172	59	14	7	25
Overall Study COMPLETED	172	59	14	7	25
Overall Study NOT COMPLETED	0	0	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

A Study of Rucaparib in Patients With Metastatic Castration-resistant Prostate Cancer and Homologous Recombination Gene Deficiency

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	BRCA Mutation n=172 Participants Patients with a deleterious BRCA (breast cancer susceptibility gene) mutation detected in their tumor.	ATM Mutation n=59 Participants Patients with a deleterious ATM (ataxia telangiectasia mutated serine/threonine kinase) mutation detected in their tumor.	CDK12 Mutation n=14 Participants Patients with a deleterious CDK12 (Cyclin-dependent kinase 12) mutation detected in their tumor.	CHEK2 Mutation n=7 Participants Patients with a deleterious CHEK2 (Checkpoint Kinase 2) mutation detected in their tumor.	Other Gene Mutation n=25 Participants Patients with other deleterious HRR (homologous recombination repair) gene mutation detected in their tumor.	Total n=277 Participants Total of all reporting groups
Age, Continuous	72 years n=5 Participants	73 years n=7 Participants	64 years n=5 Participants	65 years n=4 Participants	70 years n=21 Participants	71 years n=8 Participants
Sex: Female, Male Female	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants
Sex: Female, Male Male	172 Participants n=5 Participants	59 Participants n=7 Participants	14 Participants n=5 Participants	7 Participants n=4 Participants	25 Participants n=21 Participants	277 Participants n=8 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants
Race (NIH/OMB) Asian	3 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants	1 Participants n=21 Participants	5 Participants n=8 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	1 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	1 Participants n=8 Participants
Race (NIH/OMB) Black or African American	8 Participants n=5 Participants	3 Participants n=7 Participants	1 Participants n=5 Participants	0 Participants n=4 Participants	4 Participants n=21 Participants	16 Participants n=8 Participants
Race (NIH/OMB) White	127 Participants n=5 Participants	43 Participants n=7 Participants	6 Participants n=5 Participants	5 Participants n=4 Participants	17 Participants n=21 Participants	198 Participants n=8 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants
Race (NIH/OMB) Unknown or Not Reported	33 Participants n=5 Participants	13 Participants n=7 Participants	7 Participants n=5 Participants	1 Participants n=4 Participants	3 Participants n=21 Participants	57 Participants n=8 Participants

PRIMARY outcome

Timeframe: Assessments every 8 weeks from study day 1 for the first 24 weeks, and then every 12 weeks until disease progression, death, or initiation of subsequent treatment. Total follow-up was up to approximately 3 years.

Population: IRR Efficacy Population - The IRR efficacy population is defined by measurable disease status at baseline using modified RECIST Version 1.1 criteria per independent radiology review.

Outcome measures

Outcome measures
Measure	BRCA Mutation n=81 Participants Patients with a deleterious BRCA (breast cancer susceptibility gene) mutation detected in their tumor.	ATM Mutation n=23 Participants Patients with a deleterious ATM (ataxia telangiectasia mutated serine/threonine kinase) mutation detected in their tumor.	CDK12 Mutation n=8 Participants Patients with a deleterious CDK12 (Cyclin-dependent kinase 12) mutation detected in their tumor.	CHEK2 Mutation n=4 Participants Patients with a deleterious CHEK2 (Checkpoint Kinase 2) mutation detected in their tumor.	Other Gene Mutation n=17 Participants Patients with other deleterious HRR (homologous recombination repair) gene mutation detected in their tumor.
Confirmed Objective Response Rate (ORR) by Gene in Patients With Measurable Disease at Baseline Per Central Independent Radiology Review (IRR)	45.7 percentage of participants Interval 34.6 to 57.1	0.0 percentage of participants Interval 0.0 to 14.8	0.0 percentage of participants Interval 0.0 to 36.9	0.0 percentage of participants Interval 0.0 to 60.2	41.2 percentage of participants Interval 18.4 to 67.1

SECONDARY outcome

Population: Investigator Efficacy Population - The Investigator efficacy population is defined by measurable disease status at baseline using modified RECIST Version 1.1 criteria per the investigator (INV).

A supportive efficacy endpoint is confirmed radiographic ORR by INV. ORR is defined as the percentage of patients with a confirmed CR (complete response) or PR (partial response) by mRECIST (modified Response Evaluation Criteria in Solid Tumors) v1.1/PCWG3 (Prostate Cancer Working Group 3) criteria. The confirmed response is defined as a CR or PR on subsequent tumor assessment at least 28 days after first response documentation in the absence of confirmed progression in bone. CR is disappearance of all target and non-target lesions; any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm. PR is at least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum of diameters.

Outcome measures

Outcome measures
Measure	BRCA Mutation n=87 Participants Patients with a deleterious BRCA (breast cancer susceptibility gene) mutation detected in their tumor.	ATM Mutation n=21 Participants Patients with a deleterious ATM (ataxia telangiectasia mutated serine/threonine kinase) mutation detected in their tumor.	CDK12 Mutation n=9 Participants Patients with a deleterious CDK12 (Cyclin-dependent kinase 12) mutation detected in their tumor.	CHEK2 Mutation n=4 Participants Patients with a deleterious CHEK2 (Checkpoint Kinase 2) mutation detected in their tumor.	Other Gene Mutation n=17 Participants Patients with other deleterious HRR (homologous recombination repair) gene mutation detected in their tumor.
Confirmed Objective Response Rate (ORR) by Gene in Patients With Measurable Disease at Baseline Per Investigator (INV)	48.3 percentage of participants Interval 37.4 to 59.2	9.5 percentage of participants Interval 1.2 to 30.4	0.0 percentage of participants Interval 0.0 to 33.6	25.0 percentage of participants Interval 0.6 to 80.6	41.2 percentage of participants Interval 18.4 to 67.1

SECONDARY outcome

Population: Patients with a confirmed response in the IRR Efficacy Population. The IRR efficacy population is defined by measurable disease status at baseline using modified RECIST Version 1.1 criteria per independent radiology review. Note, there were no patients with confirmed response by IRR in the ATM, CDK12 and CHEK2 arms.

A secondary efficacy endpoint is DOR by central IRR. The DOR is defined as the time from the date that a confirmed response per modified RECIST Version 1.1/PCWG3 is first reported to the time that progressive disease (PD) is first documented. Progressive disease is defined using RECIST v1.1, as at least a 20% increase in the sum of the diameters of target lesions, or an unequivocal increase in non-target lesions, or the appearance of new lesions. PCWG3 criteria is used to document evidence of disease progression in bone lesions.

Outcome measures

Outcome measures
Measure	BRCA Mutation n=37 Participants Patients with a deleterious BRCA (breast cancer susceptibility gene) mutation detected in their tumor.	ATM Mutation n=7 Participants Patients with a deleterious ATM (ataxia telangiectasia mutated serine/threonine kinase) mutation detected in their tumor.	CDK12 Mutation Patients with a deleterious CDK12 (Cyclin-dependent kinase 12) mutation detected in their tumor.	CHEK2 Mutation Patients with a deleterious CHEK2 (Checkpoint Kinase 2) mutation detected in their tumor.	Other Gene Mutation Patients with other deleterious HRR (homologous recombination repair) gene mutation detected in their tumor.
Duration of Response (DOR) by Gene in Patients With Confirmed Response Per Central Independent Radiology Review (IRR)	15.5 months Interval 6.4 to The upper confidence interval was not assessable due to insufficient number of participants with events.	22.1 months Interval 10.1 to The upper confidence interval was not assessable due to insufficient number of participants with events.	—	—	—

SECONDARY outcome

Population: Patients with a confirmed response in the Investigator Efficacy Population. The Investigator efficacy population is defined by measurable disease status at baseline using modified RECIST Version 1.1 criteria per the investigator. Note, there were no patients with confirmed response by investigator in the CDK12 arm.

A secondary efficacy endpoint is DOR as assessed by the investigator. The DOR is defined as the time from the date that a confirmed response per modified RECIST Version 1.1/PCWG3 is first reported to the time that progressive disease (PD) is first documented. Progressive disease is defined using RECIST v1.1, as at least a 20% increase in the sum of the diameters of target lesions, or an unequivocal increase in non-target lesions, or the appearance of new lesions. PCWG3 criteria is used to document evidence of disease progression in bone lesions.

Outcome measures

Outcome measures
Measure	BRCA Mutation n=42 Participants Patients with a deleterious BRCA (breast cancer susceptibility gene) mutation detected in their tumor.	ATM Mutation n=2 Participants Patients with a deleterious ATM (ataxia telangiectasia mutated serine/threonine kinase) mutation detected in their tumor.	CDK12 Mutation n=1 Participants Patients with a deleterious CDK12 (Cyclin-dependent kinase 12) mutation detected in their tumor.	CHEK2 Mutation n=7 Participants Patients with a deleterious CHEK2 (Checkpoint Kinase 2) mutation detected in their tumor.	Other Gene Mutation Patients with other deleterious HRR (homologous recombination repair) gene mutation detected in their tumor.
Duration of Response (DOR) by Gene in Patients With Confirmed Response Per Investigator	6.6 months Interval 5.6 to 11.6	7.5 months Interval 4.6 to 10.4	16.6 months The median is the actual observed value for this participant. The confidence interval was not assessable due to insufficient number of participants with events.	18.4 months Interval 10.1 to The upper confidence interval was not assessable due to insufficient number of participants with events.	—

SECONDARY outcome

Timeframe: PSA assessments were done at baseline, Week 5, Week 9, every 4 weeks thereafter, and at Treatment Discontinuation. Total follow-up was up to approximately 39 months.

Population: All patients who had a PSA value at baseline.

A secondary endpoint is confirmed PSA (prostate-specific antigen) response (≥ 50% reduction) as assessed by local laboratory. Confirmed PSA response is analyzed for all patients who had PSA value at baseline and is defined as the percentage of patients having 2 consecutive PSA values (at least 3 weeks apart) that are at least 50% lower than baseline and that occur prior to PSA progression. PSA progression is defined as a ≥ 25% increase and absolute increase of ≥ 2 ng/mL above the nadir in PSA.

Outcome measures

Outcome measures
Measure	BRCA Mutation n=172 Participants Patients with a deleterious BRCA (breast cancer susceptibility gene) mutation detected in their tumor.	ATM Mutation n=59 Participants Patients with a deleterious ATM (ataxia telangiectasia mutated serine/threonine kinase) mutation detected in their tumor.	CDK12 Mutation n=14 Participants Patients with a deleterious CDK12 (Cyclin-dependent kinase 12) mutation detected in their tumor.	CHEK2 Mutation n=7 Participants Patients with a deleterious CHEK2 (Checkpoint Kinase 2) mutation detected in their tumor.	Other Gene Mutation n=25 Participants Patients with other deleterious HRR (homologous recombination repair) gene mutation detected in their tumor.
Confirmed PSA Response (≥ 50% Decrease) by Gene as Assessed by Local Laboratory	53.5 percentage of participants Interval 45.7 to 61.1	3.4 percentage of participants Interval 0.4 to 11.7	7.1 percentage of participants Interval 0.2 to 33.9	14.3 percentage of participants Interval 0.4 to 57.9	36.0 percentage of participants Interval 18.0 to 57.5

SECONDARY outcome

Timeframe: PSA assessments were done at baseline, Week 5, Week 9, every 4 weeks thereafter, and at Treatment Discontinuation. Total follow-up was up to approximately 39 months.

Population: All patients who had a PSA value at baseline.

A secondary endpoint is confirmed PSA (prostate-specific antigen) response (≥ 90% reduction) as assessed by local laboratory. Confirmed PSA response is analyzed for all patients who had PSA value at baseline and is defined as the percentage of patients having 2 consecutive PSA values (at least 3 weeks apart) that are at least 90% lower than baseline and that occur prior to PSA progression. PSA progression is defined as a ≥ 25% increase and absolute increase of ≥ 2 ng/mL above the nadir in PSA.

Outcome measures

Outcome measures
Measure	BRCA Mutation n=172 Participants Patients with a deleterious BRCA (breast cancer susceptibility gene) mutation detected in their tumor.	ATM Mutation n=59 Participants Patients with a deleterious ATM (ataxia telangiectasia mutated serine/threonine kinase) mutation detected in their tumor.	CDK12 Mutation n=14 Participants Patients with a deleterious CDK12 (Cyclin-dependent kinase 12) mutation detected in their tumor.	CHEK2 Mutation n=7 Participants Patients with a deleterious CHEK2 (Checkpoint Kinase 2) mutation detected in their tumor.	Other Gene Mutation n=25 Participants Patients with other deleterious HRR (homologous recombination repair) gene mutation detected in their tumor.
Confirmed PSA Response (≥ 90% Decrease) by Gene as Assessed by Local Laboratory	19.8 percentage of participants Interval 14.1 to 26.5	0 percentage of participants Interval 0.0 to 0.0	0 percentage of participants Interval 0.0 to 0.0	14.3 percentage of participants Interval 0.4 to 57.9	16.0 percentage of participants Interval 4.5 to 36.1

SECONDARY outcome

Population: All patients

A secondary efficacy endpoint is Radiologic Progression-free Survival (rPFS) assessed by IRR. rPFS is defined as the time from first dose of rucaparib to the date of first objective evidence of radiographic progression (soft tissue or bone lesion) or death due to any cause, whichever occurs first, plus 1 day. Radiographic disease progression includes confirmed bone disease progression and soft tissue disease progression adjudicated by IRR using the PCWG3 guidelines for bone disease and modified RECIST Version 1.1 for soft tissue disease.

Outcome measures

Outcome measures
Measure	BRCA Mutation n=172 Participants Patients with a deleterious BRCA (breast cancer susceptibility gene) mutation detected in their tumor.	ATM Mutation n=59 Participants Patients with a deleterious ATM (ataxia telangiectasia mutated serine/threonine kinase) mutation detected in their tumor.	CDK12 Mutation n=14 Participants Patients with a deleterious CDK12 (Cyclin-dependent kinase 12) mutation detected in their tumor.	CHEK2 Mutation n=7 Participants Patients with a deleterious CHEK2 (Checkpoint Kinase 2) mutation detected in their tumor.	Other Gene Mutation n=25 Participants Patients with other deleterious HRR (homologous recombination repair) gene mutation detected in their tumor.
Radiologic Progression-free Survival (rPFS) by Gene in All Patients Per Central Independent Radiology Review (IRR)	10.7 months Interval 8.7 to 13.2	5.3 months Interval 3.7 to 8.9	3.7 months Interval 1.9 to 8.3	9.4 months Interval 2.1 to The upper confidence interval was not assessable due to insufficient number of participants with events.	11.6 months Interval 5.1 to 25.3

SECONDARY outcome

Population: All patients

A secondary efficacy endpoint is Radiologic Progression-free Survival (rPFS) assessed by Investigator. rPFS is defined as the time from first dose of rucaparib to the date of first objective evidence of radiographic progression (soft tissue or bone lesion) or death due to any cause, whichever occurs first, plus 1 day. Radiographic disease progression includes confirmed bone disease progression and soft tissue disease progression using the PCWG3 guidelines for bone disease and modified RECIST Version 1.1 for soft tissue disease.

Outcome measures

Outcome measures
Measure	BRCA Mutation n=172 Participants Patients with a deleterious BRCA (breast cancer susceptibility gene) mutation detected in their tumor.	ATM Mutation n=59 Participants Patients with a deleterious ATM (ataxia telangiectasia mutated serine/threonine kinase) mutation detected in their tumor.	CDK12 Mutation n=14 Participants Patients with a deleterious CDK12 (Cyclin-dependent kinase 12) mutation detected in their tumor.	CHEK2 Mutation n=7 Participants Patients with a deleterious CHEK2 (Checkpoint Kinase 2) mutation detected in their tumor.	Other Gene Mutation n=25 Participants Patients with other deleterious HRR (homologous recombination repair) gene mutation detected in their tumor.
Radiologic Progression-free Survival (rPFS) by Gene in All Patients Per Investigator	9.6 months Interval 8.2 to 11.2	7.8 months Interval 4.2 to 10.6	3.7 months Interval 1.9 to 8.1	3.5 months Interval 2.1 to 11.2	11.6 months Interval 5.8 to 22.3

SECONDARY outcome

Timeframe: From date of first dose until event, loss to follow-up, withdrawal of consent, or study closure: an overall median of approximately 33.1 months

Population: Safety Population - The safety population consists of all patients who received at least 1 dose of protocol-specified treatment.

A secondary efficacy endpoint is Overall Survival (OS). OS is defined as the date from first dose of rucaparib to the date of death due to any cause, +1 day.

Outcome measures

Outcome measures
Measure	BRCA Mutation n=172 Participants Patients with a deleterious BRCA (breast cancer susceptibility gene) mutation detected in their tumor.	ATM Mutation n=59 Participants Patients with a deleterious ATM (ataxia telangiectasia mutated serine/threonine kinase) mutation detected in their tumor.	CDK12 Mutation n=14 Participants Patients with a deleterious CDK12 (Cyclin-dependent kinase 12) mutation detected in their tumor.	CHEK2 Mutation n=7 Participants Patients with a deleterious CHEK2 (Checkpoint Kinase 2) mutation detected in their tumor.	Other Gene Mutation n=25 Participants Patients with other deleterious HRR (homologous recombination repair) gene mutation detected in their tumor.
Overall Survival (OS) by Gene	17.2 months Interval 14.8 to 20.0	14.6 months Interval 12.0 to 19.0	13.9 months Interval 6.8 to 18.6	11.1 months Interval 3.5 to 26.7	11.6 months Interval 8.9 to The upper confidence interval was not assessable due to insufficient number of participants with events.

SECONDARY outcome

Population: All patients

A secondary efficacy endpoint is Clinical Benefit Rate (CBR) assessed by IRR. CBR is defined as the number of patients without radiographic progression (defined by modified RECIST Version 1.1/ PCWG3 criteria) who were continuing with study drug treatment through the given time interval divided by the number of patients who had the given amount of follow-up. Clinical benefit rates are summarized at 6 and 12 months.

Outcome measures

Outcome measures
Measure	BRCA Mutation n=172 Participants Patients with a deleterious BRCA (breast cancer susceptibility gene) mutation detected in their tumor.	ATM Mutation n=59 Participants Patients with a deleterious ATM (ataxia telangiectasia mutated serine/threonine kinase) mutation detected in their tumor.	CDK12 Mutation n=14 Participants Patients with a deleterious CDK12 (Cyclin-dependent kinase 12) mutation detected in their tumor.	CHEK2 Mutation n=7 Participants Patients with a deleterious CHEK2 (Checkpoint Kinase 2) mutation detected in their tumor.	Other Gene Mutation n=25 Participants Patients with other deleterious HRR (homologous recombination repair) gene mutation detected in their tumor.
Clinical Benefit Rate (CBR) by Gene Per Central Independent Radiology Review (IRR) 6 months	100 Participants	10 Participants	2 Participants	2 Participants	13 Participants
Clinical Benefit Rate (CBR) by Gene Per Central Independent Radiology Review (IRR) 12 months	36 Participants	3 Participants	0 Participants	1 Participants	6 Participants

SECONDARY outcome

Population: All patients

A secondary efficacy endpoint is Clinical Benefit Rate (CBR) assessed by Investigator. CBR is defined as the number of patients without radiographic progression (defined by modified RECIST Version 1.1/ PCWG3 criteria) who were continuing with study drug treatment through the given time interval divided by the number of patients who had the given amount of follow-up. Clinical benefit rates are summarized at 6 and 12 months.

Outcome measures

Outcome measures
Measure	BRCA Mutation n=172 Participants Patients with a deleterious BRCA (breast cancer susceptibility gene) mutation detected in their tumor.	ATM Mutation n=59 Participants Patients with a deleterious ATM (ataxia telangiectasia mutated serine/threonine kinase) mutation detected in their tumor.	CDK12 Mutation n=14 Participants Patients with a deleterious CDK12 (Cyclin-dependent kinase 12) mutation detected in their tumor.	CHEK2 Mutation n=7 Participants Patients with a deleterious CHEK2 (Checkpoint Kinase 2) mutation detected in their tumor.	Other Gene Mutation n=25 Participants Patients with other deleterious HRR (homologous recombination repair) gene mutation detected in their tumor.
Clinical Benefit Rate (CBR) by Gene Per Investigator 6 months	103 Participants	17 Participants	3 Participants	2 Participants	14 Participants
Clinical Benefit Rate (CBR) by Gene Per Investigator 12 months	39 Participants	6 Participants	1 Participants	1 Participants	6 Participants

SECONDARY outcome

Timeframe: PSA assessments were done at baseline, Week 5, Week 9, every 4 weeks thereafter, and at Treatment Discontinuation. Total follow-up was up to approximately 39 months.

Population: All patients who had a PSA value at baseline.

A secondary efficacy endpoint is time to PSA progession. Time to PSA progression is defined as the time from first dose of rucaparib to the date that a ≥ 25% increase and absolute increase of ≥ 2 ng/mL above the nadir (or baseline if there was no PSA decline after baseline) in PSA was measured, plus 1 day. The increase must be confirmed by a second consecutive assessment conducted at least 3 weeks later (unless the PSA progression occurred at the last recorded PSA assessment). If confirmed, the date used for time of PSA progression is the earlier of the 2 PSA dates.

Outcome measures

Outcome measures
Measure	BRCA Mutation n=172 Participants Patients with a deleterious BRCA (breast cancer susceptibility gene) mutation detected in their tumor.	ATM Mutation n=59 Participants Patients with a deleterious ATM (ataxia telangiectasia mutated serine/threonine kinase) mutation detected in their tumor.	CDK12 Mutation n=14 Participants Patients with a deleterious CDK12 (Cyclin-dependent kinase 12) mutation detected in their tumor.	CHEK2 Mutation n=7 Participants Patients with a deleterious CHEK2 (Checkpoint Kinase 2) mutation detected in their tumor.	Other Gene Mutation n=25 Participants Patients with other deleterious HRR (homologous recombination repair) gene mutation detected in their tumor.
Time to PSA Progression by Gene	6.5 months Interval 5.7 to 7.5	3.1 months Interval 2.8 to 3.7	3.5 months Interval 2.8 to 4.6	5.6 months Interval 2.8 to The upper confidence interval was not assessable due to insufficient number of participants with events.	5.3 months Interval 3.0 to 9.1

SECONDARY outcome

Timeframe: Participants were assessed at Study Day 29, Day 57, Day 85 and Day 113

Population: Safety population with at least one PK sample collected. The safety population consists of all patients who received at least 1 dose of protocol-specified treatment.

Trough (Cmin) concentrations of rucaparib are summarized for all patients with at least one PK sample collected. The absolute values of rucaparib plasma concentration at each time point are presented by gene.

Outcome measures

Outcome measures
Measure	BRCA Mutation n=101 Participants Patients with a deleterious BRCA (breast cancer susceptibility gene) mutation detected in their tumor.	ATM Mutation n=51 Participants Patients with a deleterious ATM (ataxia telangiectasia mutated serine/threonine kinase) mutation detected in their tumor.	CDK12 Mutation n=14 Participants Patients with a deleterious CDK12 (Cyclin-dependent kinase 12) mutation detected in their tumor.	CHEK2 Mutation n=5 Participants Patients with a deleterious CHEK2 (Checkpoint Kinase 2) mutation detected in their tumor.	Other Gene Mutation n=13 Participants Patients with other deleterious HRR (homologous recombination repair) gene mutation detected in their tumor.
Steady State Trough (Cmin) Level Rucaparib Concentrations Day 29	1539.565 ng/mL Standard Deviation 966.2604	1605.002 ng/mL Standard Deviation 856.2478	1639.357 ng/mL Standard Deviation 1428.5691	1286.998 ng/mL Standard Deviation 1138.2119	1189.845 ng/mL Standard Deviation 748.3045
Steady State Trough (Cmin) Level Rucaparib Concentrations Day 57	1578.353 ng/mL Standard Deviation 1057.8049	1600.380 ng/mL Standard Deviation 1198.3899	1405.167 ng/mL Standard Deviation 806.4642	1841.667 ng/mL Standard Deviation 2106.3362	1792.499 ng/mL Standard Deviation 1672.7732
Steady State Trough (Cmin) Level Rucaparib Concentrations Day 85	1308.704 ng/mL Standard Deviation 693.6717	1505.400 ng/mL Standard Deviation 802.0812	1699.700 ng/mL Standard Deviation 991.9922	815.500 ng/mL Standard Deviation 557.9073	2255.889 ng/mL Standard Deviation 1831.9626
Steady State Trough (Cmin) Level Rucaparib Concentrations Day 113	1533.690 ng/mL Standard Deviation 889.6130	1515.300 ng/mL Standard Deviation 1291.8497	1520.700 ng/mL Standard Deviation 884.1374	728.000 ng/mL Standard Deviation 469.5189	1433.875 ng/mL Standard Deviation 637.4535

Adverse Events

All Patients

Serious events: 96 serious events

Other events: 274 other events

Deaths: 8 deaths

Serious adverse events

Serious adverse events
Measure	All Patients n=277 participants at risk All patients received open-label oral rucaparib 600 mg BID (twice a day) in continuous 28-day cycles.
Blood and lymphatic system disorders Anaemia	5.1% 14/277 • Adverse events were reported from date of first dose of study drug until 28 days after last dose of study drug, approximately 4.5 years.
Blood and lymphatic system disorders Anaemia of malignant disease	0.36% 1/277 • Adverse events were reported from date of first dose of study drug until 28 days after last dose of study drug, approximately 4.5 years.
Blood and lymphatic system disorders Aplastic anaemia	0.36% 1/277 • Adverse events were reported from date of first dose of study drug until 28 days after last dose of study drug, approximately 4.5 years.
Blood and lymphatic system disorders Leukopenia	0.36% 1/277 • Adverse events were reported from date of first dose of study drug until 28 days after last dose of study drug, approximately 4.5 years.
Blood and lymphatic system disorders Neutropenia	0.36% 1/277 • Adverse events were reported from date of first dose of study drug until 28 days after last dose of study drug, approximately 4.5 years.
Blood and lymphatic system disorders Pancytopenia	0.72% 2/277 • Adverse events were reported from date of first dose of study drug until 28 days after last dose of study drug, approximately 4.5 years.
Cardiac disorders Acute coronary syndrome	1.1% 3/277 • Adverse events were reported from date of first dose of study drug until 28 days after last dose of study drug, approximately 4.5 years.
Cardiac disorders Acute myocardial infarction	1.1% 3/277 • Adverse events were reported from date of first dose of study drug until 28 days after last dose of study drug, approximately 4.5 years.
Cardiac disorders Atrial fibrillation	0.36% 1/277 • Adverse events were reported from date of first dose of study drug until 28 days after last dose of study drug, approximately 4.5 years.
Cardiac disorders Cardiac failure	0.36% 1/277 • Adverse events were reported from date of first dose of study drug until 28 days after last dose of study drug, approximately 4.5 years.
Cardiac disorders Coronary artery occlusion	0.36% 1/277 • Adverse events were reported from date of first dose of study drug until 28 days after last dose of study drug, approximately 4.5 years.
Cardiac disorders Torsade de pointes	0.36% 1/277 • Adverse events were reported from date of first dose of study drug until 28 days after last dose of study drug, approximately 4.5 years.
Cardiac disorders Ventricular tachycardia	0.36% 1/277 • Adverse events were reported from date of first dose of study drug until 28 days after last dose of study drug, approximately 4.5 years.
Gastrointestinal disorders Abdominal pain	0.36% 1/277 • Adverse events were reported from date of first dose of study drug until 28 days after last dose of study drug, approximately 4.5 years.
Gastrointestinal disorders Colitis	0.36% 1/277 • Adverse events were reported from date of first dose of study drug until 28 days after last dose of study drug, approximately 4.5 years.
Gastrointestinal disorders Diarrhoea	1.1% 3/277 • Adverse events were reported from date of first dose of study drug until 28 days after last dose of study drug, approximately 4.5 years.
Gastrointestinal disorders Gastrointestinal haemorrhage	0.36% 1/277 • Adverse events were reported from date of first dose of study drug until 28 days after last dose of study drug, approximately 4.5 years.
Gastrointestinal disorders Gastrooesophageal reflux disease	0.36% 1/277 • Adverse events were reported from date of first dose of study drug until 28 days after last dose of study drug, approximately 4.5 years.
Gastrointestinal disorders Ileus	0.36% 1/277 • Adverse events were reported from date of first dose of study drug until 28 days after last dose of study drug, approximately 4.5 years.
Gastrointestinal disorders Intestinal ischaemia	0.36% 1/277 • Adverse events were reported from date of first dose of study drug until 28 days after last dose of study drug, approximately 4.5 years.
Gastrointestinal disorders Mechanical ileus	0.36% 1/277 • Adverse events were reported from date of first dose of study drug until 28 days after last dose of study drug, approximately 4.5 years.
Gastrointestinal disorders Nausea	0.72% 2/277 • Adverse events were reported from date of first dose of study drug until 28 days after last dose of study drug, approximately 4.5 years.
Gastrointestinal disorders Oesophagitis	0.36% 1/277 • Adverse events were reported from date of first dose of study drug until 28 days after last dose of study drug, approximately 4.5 years.
Gastrointestinal disorders Rectal haemorrhage	0.36% 1/277 • Adverse events were reported from date of first dose of study drug until 28 days after last dose of study drug, approximately 4.5 years.
Gastrointestinal disorders Small intestinal obstruction	0.36% 1/277 • Adverse events were reported from date of first dose of study drug until 28 days after last dose of study drug, approximately 4.5 years.
Gastrointestinal disorders Vomiting	1.1% 3/277 • Adverse events were reported from date of first dose of study drug until 28 days after last dose of study drug, approximately 4.5 years.
General disorders Asthenia	0.72% 2/277 • Adverse events were reported from date of first dose of study drug until 28 days after last dose of study drug, approximately 4.5 years.
General disorders Fatigue	0.72% 2/277 • Adverse events were reported from date of first dose of study drug until 28 days after last dose of study drug, approximately 4.5 years.
General disorders Non-cardiac chest pain	0.36% 1/277 • Adverse events were reported from date of first dose of study drug until 28 days after last dose of study drug, approximately 4.5 years.
General disorders Pain	0.72% 2/277 • Adverse events were reported from date of first dose of study drug until 28 days after last dose of study drug, approximately 4.5 years.
General disorders Pyrexia	0.36% 1/277 • Adverse events were reported from date of first dose of study drug until 28 days after last dose of study drug, approximately 4.5 years.
Infections and infestations Abscess oral	0.36% 1/277 • Adverse events were reported from date of first dose of study drug until 28 days after last dose of study drug, approximately 4.5 years.
Infections and infestations Bacteraemia	0.36% 1/277 • Adverse events were reported from date of first dose of study drug until 28 days after last dose of study drug, approximately 4.5 years.
Infections and infestations Cellulitis	0.36% 1/277 • Adverse events were reported from date of first dose of study drug until 28 days after last dose of study drug, approximately 4.5 years.
Infections and infestations Device related infection	0.72% 2/277 • Adverse events were reported from date of first dose of study drug until 28 days after last dose of study drug, approximately 4.5 years.
Infections and infestations Fournier's gangrene	0.36% 1/277 • Adverse events were reported from date of first dose of study drug until 28 days after last dose of study drug, approximately 4.5 years.
Infections and infestations Gastroenteritis	0.36% 1/277 • Adverse events were reported from date of first dose of study drug until 28 days after last dose of study drug, approximately 4.5 years.
Infections and infestations Haemophilus infection	0.36% 1/277 • Adverse events were reported from date of first dose of study drug until 28 days after last dose of study drug, approximately 4.5 years.
Infections and infestations Infective exacerbation of chronic obstructive airways disease	0.72% 2/277 • Adverse events were reported from date of first dose of study drug until 28 days after last dose of study drug, approximately 4.5 years.
Infections and infestations Legionella infection	0.36% 1/277 • Adverse events were reported from date of first dose of study drug until 28 days after last dose of study drug, approximately 4.5 years.
Infections and infestations Paraspinal abscess	0.36% 1/277 • Adverse events were reported from date of first dose of study drug until 28 days after last dose of study drug, approximately 4.5 years.
Infections and infestations Pneumonia	2.2% 6/277 • Adverse events were reported from date of first dose of study drug until 28 days after last dose of study drug, approximately 4.5 years.
Infections and infestations Pneumonia legionella	0.36% 1/277 • Adverse events were reported from date of first dose of study drug until 28 days after last dose of study drug, approximately 4.5 years.
Infections and infestations Pneumonia staphylococcal	0.36% 1/277 • Adverse events were reported from date of first dose of study drug until 28 days after last dose of study drug, approximately 4.5 years.
Infections and infestations Pulmonary sepsis	0.36% 1/277 • Adverse events were reported from date of first dose of study drug until 28 days after last dose of study drug, approximately 4.5 years.
Infections and infestations Sepsis	1.4% 4/277 • Adverse events were reported from date of first dose of study drug until 28 days after last dose of study drug, approximately 4.5 years.
Infections and infestations Upper respiratory tract infection	0.36% 1/277 • Adverse events were reported from date of first dose of study drug until 28 days after last dose of study drug, approximately 4.5 years.
Infections and infestations Urinary tract infection	1.4% 4/277 • Adverse events were reported from date of first dose of study drug until 28 days after last dose of study drug, approximately 4.5 years.
Infections and infestations Urosepsis	1.4% 4/277 • Adverse events were reported from date of first dose of study drug until 28 days after last dose of study drug, approximately 4.5 years.
Infections and infestations Wound infection	0.36% 1/277 • Adverse events were reported from date of first dose of study drug until 28 days after last dose of study drug, approximately 4.5 years.
Injury, poisoning and procedural complications Fall	0.72% 2/277 • Adverse events were reported from date of first dose of study drug until 28 days after last dose of study drug, approximately 4.5 years.
Injury, poisoning and procedural complications Foot fracture	0.36% 1/277 • Adverse events were reported from date of first dose of study drug until 28 days after last dose of study drug, approximately 4.5 years.
Injury, poisoning and procedural complications Postoperative respiratory failure	0.36% 1/277 • Adverse events were reported from date of first dose of study drug until 28 days after last dose of study drug, approximately 4.5 years.
Injury, poisoning and procedural complications Spinal compression fracture	0.36% 1/277 • Adverse events were reported from date of first dose of study drug until 28 days after last dose of study drug, approximately 4.5 years.
Injury, poisoning and procedural complications Urinary tract stoma complication	0.36% 1/277 • Adverse events were reported from date of first dose of study drug until 28 days after last dose of study drug, approximately 4.5 years.
Investigations Blood creatinine increased	0.72% 2/277 • Adverse events were reported from date of first dose of study drug until 28 days after last dose of study drug, approximately 4.5 years.
Metabolism and nutrition disorders Dehydration	0.72% 2/277 • Adverse events were reported from date of first dose of study drug until 28 days after last dose of study drug, approximately 4.5 years.
Metabolism and nutrition disorders Electrolyte imbalance	0.36% 1/277 • Adverse events were reported from date of first dose of study drug until 28 days after last dose of study drug, approximately 4.5 years.
Metabolism and nutrition disorders Failure to thrive	0.36% 1/277 • Adverse events were reported from date of first dose of study drug until 28 days after last dose of study drug, approximately 4.5 years.
Metabolism and nutrition disorders Hypocalcaemia	0.36% 1/277 • Adverse events were reported from date of first dose of study drug until 28 days after last dose of study drug, approximately 4.5 years.
Metabolism and nutrition disorders Hypoglycaemia	0.72% 2/277 • Adverse events were reported from date of first dose of study drug until 28 days after last dose of study drug, approximately 4.5 years.
Metabolism and nutrition disorders Hypokalaemia	0.36% 1/277 • Adverse events were reported from date of first dose of study drug until 28 days after last dose of study drug, approximately 4.5 years.
Metabolism and nutrition disorders Hyponatraemia	0.72% 2/277 • Adverse events were reported from date of first dose of study drug until 28 days after last dose of study drug, approximately 4.5 years.
Musculoskeletal and connective tissue disorders Back pain	0.72% 2/277 • Adverse events were reported from date of first dose of study drug until 28 days after last dose of study drug, approximately 4.5 years.
Musculoskeletal and connective tissue disorders Muscular weakness	0.72% 2/277 • Adverse events were reported from date of first dose of study drug until 28 days after last dose of study drug, approximately 4.5 years.
Musculoskeletal and connective tissue disorders Musculoskeletal pain	0.36% 1/277 • Adverse events were reported from date of first dose of study drug until 28 days after last dose of study drug, approximately 4.5 years.
Musculoskeletal and connective tissue disorders Pain in extremity	0.72% 2/277 • Adverse events were reported from date of first dose of study drug until 28 days after last dose of study drug, approximately 4.5 years.
Musculoskeletal and connective tissue disorders Pathological fracture	1.8% 5/277 • Adverse events were reported from date of first dose of study drug until 28 days after last dose of study drug, approximately 4.5 years.
Musculoskeletal and connective tissue disorders Spinal pain	0.36% 1/277 • Adverse events were reported from date of first dose of study drug until 28 days after last dose of study drug, approximately 4.5 years.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Adenocarcinoma pancreas	0.36% 1/277 • Adverse events were reported from date of first dose of study drug until 28 days after last dose of study drug, approximately 4.5 years.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Bladder cancer	0.36% 1/277 • Adverse events were reported from date of first dose of study drug until 28 days after last dose of study drug, approximately 4.5 years.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Chronic lymphocytic leukaemia	0.36% 1/277 • Adverse events were reported from date of first dose of study drug until 28 days after last dose of study drug, approximately 4.5 years.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Malignant neoplasm progression	0.36% 1/277 • Adverse events were reported from date of first dose of study drug until 28 days after last dose of study drug, approximately 4.5 years.
Nervous system disorders Cerebellar infarction	0.36% 1/277 • Adverse events were reported from date of first dose of study drug until 28 days after last dose of study drug, approximately 4.5 years.
Nervous system disorders Cerebral haemorrhage	0.36% 1/277 • Adverse events were reported from date of first dose of study drug until 28 days after last dose of study drug, approximately 4.5 years.
Nervous system disorders Cerebrovascular accident	0.36% 1/277 • Adverse events were reported from date of first dose of study drug until 28 days after last dose of study drug, approximately 4.5 years.
Nervous system disorders Dizziness	0.36% 1/277 • Adverse events were reported from date of first dose of study drug until 28 days after last dose of study drug, approximately 4.5 years.
Nervous system disorders Dysarthria	0.36% 1/277 • Adverse events were reported from date of first dose of study drug until 28 days after last dose of study drug, approximately 4.5 years.
Nervous system disorders Ischaemic stroke	0.36% 1/277 • Adverse events were reported from date of first dose of study drug until 28 days after last dose of study drug, approximately 4.5 years.
Nervous system disorders Presyncope	0.36% 1/277 • Adverse events were reported from date of first dose of study drug until 28 days after last dose of study drug, approximately 4.5 years.
Nervous system disorders Sacral radiculopathy	0.36% 1/277 • Adverse events were reported from date of first dose of study drug until 28 days after last dose of study drug, approximately 4.5 years.
Nervous system disorders Sciatica	0.36% 1/277 • Adverse events were reported from date of first dose of study drug until 28 days after last dose of study drug, approximately 4.5 years.
Nervous system disorders Seizure	0.72% 2/277 • Adverse events were reported from date of first dose of study drug until 28 days after last dose of study drug, approximately 4.5 years.
Nervous system disorders Spinal cord compression	0.36% 1/277 • Adverse events were reported from date of first dose of study drug until 28 days after last dose of study drug, approximately 4.5 years.
Nervous system disorders Syncope	0.72% 2/277 • Adverse events were reported from date of first dose of study drug until 28 days after last dose of study drug, approximately 4.5 years.
Psychiatric disorders Confusional state	0.72% 2/277 • Adverse events were reported from date of first dose of study drug until 28 days after last dose of study drug, approximately 4.5 years.
Renal and urinary disorders Acute kidney injury	2.5% 7/277 • Adverse events were reported from date of first dose of study drug until 28 days after last dose of study drug, approximately 4.5 years.
Renal and urinary disorders Haematuria	2.2% 6/277 • Adverse events were reported from date of first dose of study drug until 28 days after last dose of study drug, approximately 4.5 years.
Renal and urinary disorders Hydronephrosis	0.36% 1/277 • Adverse events were reported from date of first dose of study drug until 28 days after last dose of study drug, approximately 4.5 years.
Renal and urinary disorders Urinary retention	1.1% 3/277 • Adverse events were reported from date of first dose of study drug until 28 days after last dose of study drug, approximately 4.5 years.
Respiratory, thoracic and mediastinal disorders Acute respiratory distress syndrome	0.36% 1/277 • Adverse events were reported from date of first dose of study drug until 28 days after last dose of study drug, approximately 4.5 years.
Respiratory, thoracic and mediastinal disorders Chronic obstructive pulmonary disease	0.36% 1/277 • Adverse events were reported from date of first dose of study drug until 28 days after last dose of study drug, approximately 4.5 years.
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.72% 2/277 • Adverse events were reported from date of first dose of study drug until 28 days after last dose of study drug, approximately 4.5 years.
Respiratory, thoracic and mediastinal disorders Epistaxis	0.36% 1/277 • Adverse events were reported from date of first dose of study drug until 28 days after last dose of study drug, approximately 4.5 years.
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	0.72% 2/277 • Adverse events were reported from date of first dose of study drug until 28 days after last dose of study drug, approximately 4.5 years.
Vascular disorders Embolism	0.36% 1/277 • Adverse events were reported from date of first dose of study drug until 28 days after last dose of study drug, approximately 4.5 years.
Vascular disorders Hypertension	0.36% 1/277 • Adverse events were reported from date of first dose of study drug until 28 days after last dose of study drug, approximately 4.5 years.
Vascular disorders Peripheral ischaemia	0.36% 1/277 • Adverse events were reported from date of first dose of study drug until 28 days after last dose of study drug, approximately 4.5 years.

Other adverse events

Other adverse events
Measure	All Patients n=277 participants at risk All patients received open-label oral rucaparib 600 mg BID (twice a day) in continuous 28-day cycles.
Blood and lymphatic system disorders Anaemia	46.6% 129/277 • Adverse events were reported from date of first dose of study drug until 28 days after last dose of study drug, approximately 4.5 years.
Blood and lymphatic system disorders Neutropenia	7.2% 20/277 • Adverse events were reported from date of first dose of study drug until 28 days after last dose of study drug, approximately 4.5 years.
Blood and lymphatic system disorders Thrombocytopenia	11.9% 33/277 • Adverse events were reported from date of first dose of study drug until 28 days after last dose of study drug, approximately 4.5 years.
Gastrointestinal disorders Abdominal pain	5.8% 16/277 • Adverse events were reported from date of first dose of study drug until 28 days after last dose of study drug, approximately 4.5 years.
Gastrointestinal disorders Constipation	27.4% 76/277 • Adverse events were reported from date of first dose of study drug until 28 days after last dose of study drug, approximately 4.5 years.
Gastrointestinal disorders Diarrhoea	23.5% 65/277 • Adverse events were reported from date of first dose of study drug until 28 days after last dose of study drug, approximately 4.5 years.
Gastrointestinal disorders Dyspepsia	6.5% 18/277 • Adverse events were reported from date of first dose of study drug until 28 days after last dose of study drug, approximately 4.5 years.
Gastrointestinal disorders Nausea	50.2% 139/277 • Adverse events were reported from date of first dose of study drug until 28 days after last dose of study drug, approximately 4.5 years.
Gastrointestinal disorders Vomiting	24.2% 67/277 • Adverse events were reported from date of first dose of study drug until 28 days after last dose of study drug, approximately 4.5 years.
General disorders Asthenia	18.1% 50/277 • Adverse events were reported from date of first dose of study drug until 28 days after last dose of study drug, approximately 4.5 years.
General disorders Fatigue	47.3% 131/277 • Adverse events were reported from date of first dose of study drug until 28 days after last dose of study drug, approximately 4.5 years.
General disorders Oedema peripheral	18.1% 50/277 • Adverse events were reported from date of first dose of study drug until 28 days after last dose of study drug, approximately 4.5 years.
General disorders Pyrexia	5.4% 15/277 • Adverse events were reported from date of first dose of study drug until 28 days after last dose of study drug, approximately 4.5 years.
Infections and infestations Upper respiratory tract infection	6.9% 19/277 • Adverse events were reported from date of first dose of study drug until 28 days after last dose of study drug, approximately 4.5 years.
Infections and infestations Urinary tract infection	13.4% 37/277 • Adverse events were reported from date of first dose of study drug until 28 days after last dose of study drug, approximately 4.5 years.
Injury, poisoning and procedural complications Fall	6.5% 18/277 • Adverse events were reported from date of first dose of study drug until 28 days after last dose of study drug, approximately 4.5 years.
Investigations Alanine aminotransferase increased	26.0% 72/277 • Adverse events were reported from date of first dose of study drug until 28 days after last dose of study drug, approximately 4.5 years.
Investigations Aspartate aminotransferase increased	25.6% 71/277 • Adverse events were reported from date of first dose of study drug until 28 days after last dose of study drug, approximately 4.5 years.
Investigations Blood alkaline phosphatase increased	6.5% 18/277 • Adverse events were reported from date of first dose of study drug until 28 days after last dose of study drug, approximately 4.5 years.
Investigations Blood creatinine increased	18.1% 50/277 • Adverse events were reported from date of first dose of study drug until 28 days after last dose of study drug, approximately 4.5 years.
Investigations Platelet count decreased	11.6% 32/277 • Adverse events were reported from date of first dose of study drug until 28 days after last dose of study drug, approximately 4.5 years.
Investigations Weight decreased	16.2% 45/277 • Adverse events were reported from date of first dose of study drug until 28 days after last dose of study drug, approximately 4.5 years.
Metabolism and nutrition disorders Decreased appetite	34.7% 96/277 • Adverse events were reported from date of first dose of study drug until 28 days after last dose of study drug, approximately 4.5 years.
Metabolism and nutrition disorders Dehydration	5.1% 14/277 • Adverse events were reported from date of first dose of study drug until 28 days after last dose of study drug, approximately 4.5 years.
Metabolism and nutrition disorders Hypocalcaemia	7.6% 21/277 • Adverse events were reported from date of first dose of study drug until 28 days after last dose of study drug, approximately 4.5 years.
Metabolism and nutrition disorders Hypophosphataemia	9.7% 27/277 • Adverse events were reported from date of first dose of study drug until 28 days after last dose of study drug, approximately 4.5 years.
Musculoskeletal and connective tissue disorders Althralgia	15.9% 44/277 • Adverse events were reported from date of first dose of study drug until 28 days after last dose of study drug, approximately 4.5 years.
Musculoskeletal and connective tissue disorders Back pain	18.1% 50/277 • Adverse events were reported from date of first dose of study drug until 28 days after last dose of study drug, approximately 4.5 years.
Musculoskeletal and connective tissue disorders Bone pain	6.5% 18/277 • Adverse events were reported from date of first dose of study drug until 28 days after last dose of study drug, approximately 4.5 years.
Musculoskeletal and connective tissue disorders Muscular weakness	6.1% 17/277 • Adverse events were reported from date of first dose of study drug until 28 days after last dose of study drug, approximately 4.5 years.
Musculoskeletal and connective tissue disorders Musculoskeletal chest pain	5.1% 14/277 • Adverse events were reported from date of first dose of study drug until 28 days after last dose of study drug, approximately 4.5 years.
Musculoskeletal and connective tissue disorders Musculoskeletal pain	11.9% 33/277 • Adverse events were reported from date of first dose of study drug until 28 days after last dose of study drug, approximately 4.5 years.
Musculoskeletal and connective tissue disorders Myalgia	5.1% 14/277 • Adverse events were reported from date of first dose of study drug until 28 days after last dose of study drug, approximately 4.5 years.
Musculoskeletal and connective tissue disorders Pain in extremity	11.6% 32/277 • Adverse events were reported from date of first dose of study drug until 28 days after last dose of study drug, approximately 4.5 years.
Nervous system disorders Dizziness	19.1% 53/277 • Adverse events were reported from date of first dose of study drug until 28 days after last dose of study drug, approximately 4.5 years.
Nervous system disorders Dysgeusia	11.6% 32/277 • Adverse events were reported from date of first dose of study drug until 28 days after last dose of study drug, approximately 4.5 years.
Nervous system disorders Headache	10.1% 28/277 • Adverse events were reported from date of first dose of study drug until 28 days after last dose of study drug, approximately 4.5 years.
Nervous system disorders Neuropathy peripheral	5.1% 14/277 • Adverse events were reported from date of first dose of study drug until 28 days after last dose of study drug, approximately 4.5 years.
Psychiatric disorders Insomnia	6.5% 18/277 • Adverse events were reported from date of first dose of study drug until 28 days after last dose of study drug, approximately 4.5 years.
Renal and urinary disorders Haematuria	7.6% 21/277 • Adverse events were reported from date of first dose of study drug until 28 days after last dose of study drug, approximately 4.5 years.
Respiratory, thoracic and mediastinal disorders Dyspnoea	14.4% 40/277 • Adverse events were reported from date of first dose of study drug until 28 days after last dose of study drug, approximately 4.5 years.
Skin and subcutaneous tissue disorders Dry skin	6.5% 18/277 • Adverse events were reported from date of first dose of study drug until 28 days after last dose of study drug, approximately 4.5 years.
Skin and subcutaneous tissue disorders Photosensitivity reaction	6.9% 19/277 • Adverse events were reported from date of first dose of study drug until 28 days after last dose of study drug, approximately 4.5 years.
Skin and subcutaneous tissue disorders Rash	7.9% 22/277 • Adverse events were reported from date of first dose of study drug until 28 days after last dose of study drug, approximately 4.5 years.
Vascular disorders Hypertension	7.2% 20/277 • Adverse events were reported from date of first dose of study drug until 28 days after last dose of study drug, approximately 4.5 years.
Respiratory, thoracic and mediastinal disorders Cough	11.9% 33/277 • Adverse events were reported from date of first dose of study drug until 28 days after last dose of study drug, approximately 4.5 years.

Additional Information

Medical Information Department

Clovis Oncology, Inc.

Phone: +1 415 409 7220

Email: [email protected]

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