Trial Outcomes & Findings for Abiraterone Acetate and Prednisone With or Without Veliparib in Treating Patients With Metastatic Castration-Resistant Prostate Cancer (NCT NCT01576172)

NCT ID: NCT01576172

Last Updated: 2020-11-12

Results Overview

50% or greater decline in PSA from baseline.

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 159 participants
• Primary outcome timeframe: Up to 3 years
• Results posted on: 2020-11-12

Participant Flow

Participant milestones

Measure	Arm I (Abiraterone Acetate and Prednisone) Patients receive abiraterone acetate PO QD and prednisone PO BID on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Abiraterone Acetate: Given PO Laboratory Biomarker Analysis: Correlative studies Prednisone: Given PO	Arm II (Abiraterone Acetate, Prednisone, and Veliparib) Patients receive veliparib PO BID on days 1-28. Patients also receive abiraterone acetate PO QD and prednisone PO BID on day 1 (day 8 of course 1). Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Abiraterone Acetate: Given PO Laboratory Biomarker Analysis: Correlative studies Prednisone: Given PO Veliparib: Given PO
Overall Study STARTED	79	80
Overall Study COMPLETED	74	79
Overall Study NOT COMPLETED	5	1

Reasons for withdrawal

Measure	Arm I (Abiraterone Acetate and Prednisone) Patients receive abiraterone acetate PO QD and prednisone PO BID on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Abiraterone Acetate: Given PO Laboratory Biomarker Analysis: Correlative studies Prednisone: Given PO	Arm II (Abiraterone Acetate, Prednisone, and Veliparib) Patients receive veliparib PO BID on days 1-28. Patients also receive abiraterone acetate PO QD and prednisone PO BID on day 1 (day 8 of course 1). Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Abiraterone Acetate: Given PO Laboratory Biomarker Analysis: Correlative studies Prednisone: Given PO Veliparib: Given PO
Overall Study Ineligible	2	1
Overall Study Withdrawal by Subject	2	0
Overall Study Insurance issue	1	0

Baseline Characteristics

Abiraterone Acetate and Prednisone With or Without Veliparib in Treating Patients With Metastatic Castration-Resistant Prostate Cancer

Baseline characteristics by cohort

Measure	Arm I (Abiraterone Acetate and Prednisone) n=74 Participants Patients receive abiraterone acetate PO QD and prednisone PO BID on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Abiraterone Acetate: Given PO Prednisone: Given PO	Arm II (Abiraterone Acetate, Prednisone, and Veliparib) n=79 Participants Patients receive veliparib PO BID on days 1-28. Patients also receive abiraterone acetate PO QD and prednisone PO BID on day 1 (day 8 of course 1). Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Abiraterone Acetate: Given PO Prednisone: Given PO Veliparib: Given PO	Total n=153 Participants Total of all reporting groups
Age, Continuous	69 years n=93 Participants	68 years n=4 Participants	68 years n=27 Participants
Sex: Female, Male Female	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Sex: Female, Male Male	74 Participants n=93 Participants	79 Participants n=4 Participants	153 Participants n=27 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) Asian	2 Participants n=93 Participants	2 Participants n=4 Participants	4 Participants n=27 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	1 Participants n=93 Participants	0 Participants n=4 Participants	1 Participants n=27 Participants
Race (NIH/OMB) Black or African American	9 Participants n=93 Participants	3 Participants n=4 Participants	12 Participants n=27 Participants
Race (NIH/OMB) White	61 Participants n=93 Participants	74 Participants n=4 Participants	135 Participants n=27 Participants
Race (NIH/OMB) More than one race	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=93 Participants	0 Participants n=4 Participants	1 Participants n=27 Participants

PRIMARY outcome

Timeframe: Up to 3 years

Population: 2 patients non-evaluable in Arm I and 3 patients non-evaluable in Arm II due to receiving \<2 treatment cycles

50% or greater decline in PSA from baseline.

Outcome measures

Measure	Arm I (Abiraterone Acetate and Prednisone) n=72 Participants Patients receive abiraterone acetate PO QD and prednisone PO BID on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Abiraterone Acetate: Given PO Prednisone: Given PO	Arm II (Abiraterone Acetate, Prednisone, and Veliparib) n=76 Participants Patients receive veliparib PO BID on days 1-28. Patients also receive abiraterone acetate PO QD and prednisone PO BID on day 1 (day 8 of course 1). Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Abiraterone Acetate: Given PO Prednisone: Given PO Veliparib: Given PO
Confirmed Prostate-specific Antigen (PSA) Response Rate	46 Participants	55 Participants

SECONDARY outcome

Timeframe: 12 weeks

Population: 3 patients in Arm 1 and 13 patients in Arm 2 had missing data.

Change in PSA from baseline to 12 weeks

Outcome measures

Measure	Arm I (Abiraterone Acetate and Prednisone) n=71 Participants Patients receive abiraterone acetate PO QD and prednisone PO BID on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Abiraterone Acetate: Given PO Prednisone: Given PO	Arm II (Abiraterone Acetate, Prednisone, and Veliparib) n=66 Participants Patients receive veliparib PO BID on days 1-28. Patients also receive abiraterone acetate PO QD and prednisone PO BID on day 1 (day 8 of course 1). Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Abiraterone Acetate: Given PO Prednisone: Given PO Veliparib: Given PO
Rates of PSA Decline	-41.1 ng/ml Standard Error 15.7	-52.9 ng/ml Standard Error 26.5

SECONDARY outcome

Timeframe: Up to 3 years

Population: Subset of patients with measurable disease.

Overall response per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by CT or MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.

Outcome measures

Measure	Arm I (Abiraterone Acetate and Prednisone) n=40 Participants Patients receive abiraterone acetate PO QD and prednisone PO BID on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Abiraterone Acetate: Given PO Prednisone: Given PO	Arm II (Abiraterone Acetate, Prednisone, and Veliparib) n=46 Participants Patients receive veliparib PO BID on days 1-28. Patients also receive abiraterone acetate PO QD and prednisone PO BID on day 1 (day 8 of course 1). Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Abiraterone Acetate: Given PO Prednisone: Given PO Veliparib: Given PO
Objective Response Rates in Patients With Measurable Disease.	18 Participants	24 Participants

SECONDARY outcome

Timeframe: Up to 42 months

Time from randomization to disease progression or death.

Outcome measures

Measure	Arm I (Abiraterone Acetate and Prednisone) n=72 Participants Patients receive abiraterone acetate PO QD and prednisone PO BID on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Abiraterone Acetate: Given PO Prednisone: Given PO	Arm II (Abiraterone Acetate, Prednisone, and Veliparib) n=76 Participants Patients receive veliparib PO BID on days 1-28. Patients also receive abiraterone acetate PO QD and prednisone PO BID on day 1 (day 8 of course 1). Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Abiraterone Acetate: Given PO Prednisone: Given PO Veliparib: Given PO
Progression-free Survival (PFS)	10.1 months Interval 8.2 to 13.8	11.0 months Interval 8.1 to 13.6

SECONDARY outcome

Timeframe: 30 days after completion of study treatment

Grade 4 or greater toxicity graded by the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0 at least possibly related to treatment.

Outcome measures

Measure	Arm I (Abiraterone Acetate and Prednisone) n=74 Participants Patients receive abiraterone acetate PO QD and prednisone PO BID on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Abiraterone Acetate: Given PO Prednisone: Given PO	Arm II (Abiraterone Acetate, Prednisone, and Veliparib) n=79 Participants Patients receive veliparib PO BID on days 1-28. Patients also receive abiraterone acetate PO QD and prednisone PO BID on day 1 (day 8 of course 1). Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Abiraterone Acetate: Given PO Prednisone: Given PO Veliparib: Given PO
Grade 4 or 5 Adverse Events	1 Participants	3 Participants

Adverse Events

Arm I (Abiraterone Acetate and Prednisone)

Serious events: 15 serious events

Other events: 74 other events

Deaths: 0 deaths

Arm II (Abiraterone Acetate, Prednisone, and Veliparib)

Serious events: 17 serious events

Other events: 79 other events

Deaths: 1 deaths

Serious adverse events

Measure	Arm I (Abiraterone Acetate and Prednisone) n=74 participants at risk Patients receive abiraterone acetate PO QD and prednisone PO BID on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Abiraterone Acetate: Given PO Laboratory Biomarker Analysis: Correlative studies Prednisone: Given PO	Arm II (Abiraterone Acetate, Prednisone, and Veliparib) n=79 participants at risk Patients receive veliparib PO BID on days 1-28. Patients also receive abiraterone acetate PO QD and prednisone PO BID on day 1 (day 8 of course 1). Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Abiraterone Acetate: Given PO Laboratory Biomarker Analysis: Correlative studies Prednisone: Given PO Veliparib: Given PO
Gastrointestinal disorders Abdominal pain	0.00% 0/74 • 30 days after completion of study treatment (up to 42 months). Toxicity graded by the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0 without regard to attribution.	1.3% 1/79 • 30 days after completion of study treatment (up to 42 months). Toxicity graded by the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0 without regard to attribution.
Blood and lymphatic system disorders Anemia	1.4% 1/74 • 30 days after completion of study treatment (up to 42 months). Toxicity graded by the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0 without regard to attribution.	1.3% 1/79 • 30 days after completion of study treatment (up to 42 months). Toxicity graded by the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0 without regard to attribution.
Cardiac disorders Atrial fibrillation	0.00% 0/74 • 30 days after completion of study treatment (up to 42 months). Toxicity graded by the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0 without regard to attribution.	2.5% 2/79 • 30 days after completion of study treatment (up to 42 months). Toxicity graded by the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0 without regard to attribution.
Cardiac disorders Chest pain - cardiac	0.00% 0/74 • 30 days after completion of study treatment (up to 42 months). Toxicity graded by the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0 without regard to attribution.	1.3% 1/79 • 30 days after completion of study treatment (up to 42 months). Toxicity graded by the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0 without regard to attribution.
Gastrointestinal disorders Colonic obstruction	1.4% 1/74 • 30 days after completion of study treatment (up to 42 months). Toxicity graded by the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0 without regard to attribution.	0.00% 0/79 • 30 days after completion of study treatment (up to 42 months). Toxicity graded by the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0 without regard to attribution.
Psychiatric disorders Confusion	0.00% 0/74 • 30 days after completion of study treatment (up to 42 months). Toxicity graded by the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0 without regard to attribution.	1.3% 1/79 • 30 days after completion of study treatment (up to 42 months). Toxicity graded by the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0 without regard to attribution.
Renal and urinary disorders Cystitis noninfective	1.4% 1/74 • 30 days after completion of study treatment (up to 42 months). Toxicity graded by the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0 without regard to attribution.	0.00% 0/79 • 30 days after completion of study treatment (up to 42 months). Toxicity graded by the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0 without regard to attribution.
Metabolism and nutrition disorders Dehydration	0.00% 0/74 • 30 days after completion of study treatment (up to 42 months). Toxicity graded by the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0 without regard to attribution.	2.5% 2/79 • 30 days after completion of study treatment (up to 42 months). Toxicity graded by the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0 without regard to attribution.
Respiratory, thoracic and mediastinal disorders Dyspnea	1.4% 1/74 • 30 days after completion of study treatment (up to 42 months). Toxicity graded by the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0 without regard to attribution.	1.3% 1/79 • 30 days after completion of study treatment (up to 42 months). Toxicity graded by the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0 without regard to attribution.
Injury, poisoning and procedural complications Fall	2.7% 2/74 • 30 days after completion of study treatment (up to 42 months). Toxicity graded by the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0 without regard to attribution.	1.3% 1/79 • 30 days after completion of study treatment (up to 42 months). Toxicity graded by the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0 without regard to attribution.
General disorders General disorders and administration site conditions - Other, specify	1.4% 1/74 • 30 days after completion of study treatment (up to 42 months). Toxicity graded by the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0 without regard to attribution.	0.00% 0/79 • 30 days after completion of study treatment (up to 42 months). Toxicity graded by the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0 without regard to attribution.
Nervous system disorders Headache	0.00% 0/74 • 30 days after completion of study treatment (up to 42 months). Toxicity graded by the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0 without regard to attribution.	1.3% 1/79 • 30 days after completion of study treatment (up to 42 months). Toxicity graded by the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0 without regard to attribution.
Cardiac disorders Heart failure	2.7% 2/74 • 30 days after completion of study treatment (up to 42 months). Toxicity graded by the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0 without regard to attribution.	0.00% 0/79 • 30 days after completion of study treatment (up to 42 months). Toxicity graded by the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0 without regard to attribution.
Injury, poisoning and procedural complications Hip fracture	1.4% 1/74 • 30 days after completion of study treatment (up to 42 months). Toxicity graded by the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0 without regard to attribution.	0.00% 0/79 • 30 days after completion of study treatment (up to 42 months). Toxicity graded by the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0 without regard to attribution.
Metabolism and nutrition disorders Hyperglycemia	1.4% 1/74 • 30 days after completion of study treatment (up to 42 months). Toxicity graded by the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0 without regard to attribution.	1.3% 1/79 • 30 days after completion of study treatment (up to 42 months). Toxicity graded by the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0 without regard to attribution.
Vascular disorders Hypertension	1.4% 1/74 • 30 days after completion of study treatment (up to 42 months). Toxicity graded by the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0 without regard to attribution.	1.3% 1/79 • 30 days after completion of study treatment (up to 42 months). Toxicity graded by the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0 without regard to attribution.
Metabolism and nutrition disorders Hypoglycemia	1.4% 1/74 • 30 days after completion of study treatment (up to 42 months). Toxicity graded by the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0 without regard to attribution.	0.00% 0/79 • 30 days after completion of study treatment (up to 42 months). Toxicity graded by the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0 without regard to attribution.
Metabolism and nutrition disorders Hypokalemia	1.4% 1/74 • 30 days after completion of study treatment (up to 42 months). Toxicity graded by the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0 without regard to attribution.	1.3% 1/79 • 30 days after completion of study treatment (up to 42 months). Toxicity graded by the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0 without regard to attribution.
Vascular disorders Hypotension	0.00% 0/74 • 30 days after completion of study treatment (up to 42 months). Toxicity graded by the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0 without regard to attribution.	1.3% 1/79 • 30 days after completion of study treatment (up to 42 months). Toxicity graded by the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0 without regard to attribution.
Respiratory, thoracic and mediastinal disorders Hypoxia	1.4% 1/74 • 30 days after completion of study treatment (up to 42 months). Toxicity graded by the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0 without regard to attribution.	0.00% 0/79 • 30 days after completion of study treatment (up to 42 months). Toxicity graded by the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0 without regard to attribution.
Psychiatric disorders Insomnia	0.00% 0/74 • 30 days after completion of study treatment (up to 42 months). Toxicity graded by the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0 without regard to attribution.	2.5% 2/79 • 30 days after completion of study treatment (up to 42 months). Toxicity graded by the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0 without regard to attribution.
Infections and infestations Lung infection	1.4% 1/74 • 30 days after completion of study treatment (up to 42 months). Toxicity graded by the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0 without regard to attribution.	1.3% 1/79 • 30 days after completion of study treatment (up to 42 months). Toxicity graded by the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0 without regard to attribution.
Metabolism and nutrition disorders Metabolism and nutrition disorders - Other, specify	0.00% 0/74 • 30 days after completion of study treatment (up to 42 months). Toxicity graded by the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0 without regard to attribution.	1.3% 1/79 • 30 days after completion of study treatment (up to 42 months). Toxicity graded by the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0 without regard to attribution.
Cardiac disorders Myocardial infarction	1.4% 1/74 • 30 days after completion of study treatment (up to 42 months). Toxicity graded by the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0 without regard to attribution.	1.3% 1/79 • 30 days after completion of study treatment (up to 42 months). Toxicity graded by the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0 without regard to attribution.
Gastrointestinal disorders Nausea	0.00% 0/74 • 30 days after completion of study treatment (up to 42 months). Toxicity graded by the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0 without regard to attribution.	2.5% 2/79 • 30 days after completion of study treatment (up to 42 months). Toxicity graded by the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0 without regard to attribution.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other, specify	1.4% 1/74 • 30 days after completion of study treatment (up to 42 months). Toxicity graded by the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0 without regard to attribution.	0.00% 0/79 • 30 days after completion of study treatment (up to 42 months). Toxicity graded by the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0 without regard to attribution.
Nervous system disorders Nervous system disorders - Other, specify	0.00% 0/74 • 30 days after completion of study treatment (up to 42 months). Toxicity graded by the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0 without regard to attribution.	1.3% 1/79 • 30 days after completion of study treatment (up to 42 months). Toxicity graded by the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0 without regard to attribution.
General disorders Non-cardiac chest pain	1.4% 1/74 • 30 days after completion of study treatment (up to 42 months). Toxicity graded by the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0 without regard to attribution.	1.3% 1/79 • 30 days after completion of study treatment (up to 42 months). Toxicity graded by the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0 without regard to attribution.
General disorders Pain	0.00% 0/74 • 30 days after completion of study treatment (up to 42 months). Toxicity graded by the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0 without regard to attribution.	1.3% 1/79 • 30 days after completion of study treatment (up to 42 months). Toxicity graded by the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0 without regard to attribution.
Metabolism and nutrition disorders Pain in extremity	1.4% 1/74 • 30 days after completion of study treatment (up to 42 months). Toxicity graded by the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0 without regard to attribution.	0.00% 0/79 • 30 days after completion of study treatment (up to 42 months). Toxicity graded by the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0 without regard to attribution.
Investigations Platelet count decreased	0.00% 0/74 • 30 days after completion of study treatment (up to 42 months). Toxicity graded by the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0 without regard to attribution.	1.3% 1/79 • 30 days after completion of study treatment (up to 42 months). Toxicity graded by the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0 without regard to attribution.
Respiratory, thoracic and mediastinal disorders Pneumonitis	1.4% 1/74 • 30 days after completion of study treatment (up to 42 months). Toxicity graded by the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0 without regard to attribution.	0.00% 0/79 • 30 days after completion of study treatment (up to 42 months). Toxicity graded by the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0 without regard to attribution.
Nervous system disorders Presyncope	1.4% 1/74 • 30 days after completion of study treatment (up to 42 months). Toxicity graded by the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0 without regard to attribution.	1.3% 1/79 • 30 days after completion of study treatment (up to 42 months). Toxicity graded by the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0 without regard to attribution.
Renal and urinary disorders Renal calculi	0.00% 0/74 • 30 days after completion of study treatment (up to 42 months). Toxicity graded by the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0 without regard to attribution.	1.3% 1/79 • 30 days after completion of study treatment (up to 42 months). Toxicity graded by the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0 without regard to attribution.
Respiratory, thoracic and mediastinal disorders Respiratory, thoracic and mediastinal disorders - Other, specify	0.00% 0/74 • 30 days after completion of study treatment (up to 42 months). Toxicity graded by the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0 without regard to attribution.	1.3% 1/79 • 30 days after completion of study treatment (up to 42 months). Toxicity graded by the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0 without regard to attribution.
Psychiatric disorders Restlessness	0.00% 0/74 • 30 days after completion of study treatment (up to 42 months). Toxicity graded by the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0 without regard to attribution.	2.5% 2/79 • 30 days after completion of study treatment (up to 42 months). Toxicity graded by the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0 without regard to attribution.
Infections and infestations Sepsis	0.00% 0/74 • 30 days after completion of study treatment (up to 42 months). Toxicity graded by the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0 without regard to attribution.	1.3% 1/79 • 30 days after completion of study treatment (up to 42 months). Toxicity graded by the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0 without regard to attribution.
Cardiac disorders Sinus tachycardia	0.00% 0/74 • 30 days after completion of study treatment (up to 42 months). Toxicity graded by the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0 without regard to attribution.	1.3% 1/79 • 30 days after completion of study treatment (up to 42 months). Toxicity graded by the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0 without regard to attribution.
Gastrointestinal disorders Small intestinal obstruction	1.4% 1/74 • 30 days after completion of study treatment (up to 42 months). Toxicity graded by the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0 without regard to attribution.	0.00% 0/79 • 30 days after completion of study treatment (up to 42 months). Toxicity graded by the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0 without regard to attribution.
Nervous system disorders Stroke	0.00% 0/74 • 30 days after completion of study treatment (up to 42 months). Toxicity graded by the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0 without regard to attribution.	1.3% 1/79 • 30 days after completion of study treatment (up to 42 months). Toxicity graded by the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0 without regard to attribution.
Surgical and medical procedures Surgical and medical procedures - Other, specify	1.4% 1/74 • 30 days after completion of study treatment (up to 42 months). Toxicity graded by the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0 without regard to attribution.	0.00% 0/79 • 30 days after completion of study treatment (up to 42 months). Toxicity graded by the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0 without regard to attribution.
Nervous system disorders Syncope	0.00% 0/74 • 30 days after completion of study treatment (up to 42 months). Toxicity graded by the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0 without regard to attribution.	1.3% 1/79 • 30 days after completion of study treatment (up to 42 months). Toxicity graded by the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0 without regard to attribution.
Vascular disorders Thromboembolic event	2.7% 2/74 • 30 days after completion of study treatment (up to 42 months). Toxicity graded by the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0 without regard to attribution.	1.3% 1/79 • 30 days after completion of study treatment (up to 42 months). Toxicity graded by the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0 without regard to attribution.
Injury, poisoning and procedural complications Urostomy obstruction	0.00% 0/74 • 30 days after completion of study treatment (up to 42 months). Toxicity graded by the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0 without regard to attribution.	1.3% 1/79 • 30 days after completion of study treatment (up to 42 months). Toxicity graded by the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0 without regard to attribution.
Gastrointestinal disorders Vomiting	0.00% 0/74 • 30 days after completion of study treatment (up to 42 months). Toxicity graded by the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0 without regard to attribution.	3.8% 3/79 • 30 days after completion of study treatment (up to 42 months). Toxicity graded by the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0 without regard to attribution.
Infections and infestations Wound infection	0.00% 0/74 • 30 days after completion of study treatment (up to 42 months). Toxicity graded by the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0 without regard to attribution.	1.3% 1/79 • 30 days after completion of study treatment (up to 42 months). Toxicity graded by the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0 without regard to attribution.
Gastrointestinal disorders Dyspepsia	1.4% 1/74 • 30 days after completion of study treatment (up to 42 months). Toxicity graded by the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0 without regard to attribution.	0.00% 0/79 • 30 days after completion of study treatment (up to 42 months). Toxicity graded by the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0 without regard to attribution.

Other adverse events

Measure	Arm I (Abiraterone Acetate and Prednisone) n=74 participants at risk Patients receive abiraterone acetate PO QD and prednisone PO BID on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Abiraterone Acetate: Given PO Laboratory Biomarker Analysis: Correlative studies Prednisone: Given PO	Arm II (Abiraterone Acetate, Prednisone, and Veliparib) n=79 participants at risk Patients receive veliparib PO BID on days 1-28. Patients also receive abiraterone acetate PO QD and prednisone PO BID on day 1 (day 8 of course 1). Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Abiraterone Acetate: Given PO Laboratory Biomarker Analysis: Correlative studies Prednisone: Given PO Veliparib: Given PO
Gastrointestinal disorders Abdominal pain	12.2% 9/74 • 30 days after completion of study treatment (up to 42 months). Toxicity graded by the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0 without regard to attribution.	6.3% 5/79 • 30 days after completion of study treatment (up to 42 months). Toxicity graded by the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0 without regard to attribution.
Investigations Alanine aminotransferase increased	18.9% 14/74 • 30 days after completion of study treatment (up to 42 months). Toxicity graded by the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0 without regard to attribution.	8.9% 7/79 • 30 days after completion of study treatment (up to 42 months). Toxicity graded by the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0 without regard to attribution.
Investigations Alkaline phosphatase increased	25.7% 19/74 • 30 days after completion of study treatment (up to 42 months). Toxicity graded by the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0 without regard to attribution.	19.0% 15/79 • 30 days after completion of study treatment (up to 42 months). Toxicity graded by the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0 without regard to attribution.
Blood and lymphatic system disorders Anemia	32.4% 24/74 • 30 days after completion of study treatment (up to 42 months). Toxicity graded by the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0 without regard to attribution.	32.9% 26/79 • 30 days after completion of study treatment (up to 42 months). Toxicity graded by the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0 without regard to attribution.
Metabolism and nutrition disorders Anorexia	9.5% 7/74 • 30 days after completion of study treatment (up to 42 months). Toxicity graded by the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0 without regard to attribution.	15.2% 12/79 • 30 days after completion of study treatment (up to 42 months). Toxicity graded by the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0 without regard to attribution.
Psychiatric disorders Anxiety	4.1% 3/74 • 30 days after completion of study treatment (up to 42 months). Toxicity graded by the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0 without regard to attribution.	8.9% 7/79 • 30 days after completion of study treatment (up to 42 months). Toxicity graded by the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0 without regard to attribution.
Musculoskeletal and connective tissue disorders Arthralgia	4.1% 3/74 • 30 days after completion of study treatment (up to 42 months). Toxicity graded by the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0 without regard to attribution.	8.9% 7/79 • 30 days after completion of study treatment (up to 42 months). Toxicity graded by the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0 without regard to attribution.
Investigations Aspartate aminotransferase increased	23.0% 17/74 • 30 days after completion of study treatment (up to 42 months). Toxicity graded by the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0 without regard to attribution.	12.7% 10/79 • 30 days after completion of study treatment (up to 42 months). Toxicity graded by the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0 without regard to attribution.
Musculoskeletal and connective tissue disorders Back pain	31.1% 23/74 • 30 days after completion of study treatment (up to 42 months). Toxicity graded by the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0 without regard to attribution.	20.3% 16/79 • 30 days after completion of study treatment (up to 42 months). Toxicity graded by the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0 without regard to attribution.
Investigations Blood bilirubin increased	10.8% 8/74 • 30 days after completion of study treatment (up to 42 months). Toxicity graded by the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0 without regard to attribution.	6.3% 5/79 • 30 days after completion of study treatment (up to 42 months). Toxicity graded by the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0 without regard to attribution.
Musculoskeletal and connective tissue disorders Bone pain	18.9% 14/74 • 30 days after completion of study treatment (up to 42 months). Toxicity graded by the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0 without regard to attribution.	12.7% 10/79 • 30 days after completion of study treatment (up to 42 months). Toxicity graded by the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0 without regard to attribution.
Injury, poisoning and procedural complications Bruising	8.1% 6/74 • 30 days after completion of study treatment (up to 42 months). Toxicity graded by the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0 without regard to attribution.	17.7% 14/79 • 30 days after completion of study treatment (up to 42 months). Toxicity graded by the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0 without regard to attribution.
Gastrointestinal disorders Constipation	12.2% 9/74 • 30 days after completion of study treatment (up to 42 months). Toxicity graded by the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0 without regard to attribution.	15.2% 12/79 • 30 days after completion of study treatment (up to 42 months). Toxicity graded by the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0 without regard to attribution.
Respiratory, thoracic and mediastinal disorders Cough	18.9% 14/74 • 30 days after completion of study treatment (up to 42 months). Toxicity graded by the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0 without regard to attribution.	12.7% 10/79 • 30 days after completion of study treatment (up to 42 months). Toxicity graded by the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0 without regard to attribution.
Investigations Creatinine increased	10.8% 8/74 • 30 days after completion of study treatment (up to 42 months). Toxicity graded by the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0 without regard to attribution.	10.1% 8/79 • 30 days after completion of study treatment (up to 42 months). Toxicity graded by the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0 without regard to attribution.
Renal and urinary disorders Cystitis noninfective	4.1% 3/74 • 30 days after completion of study treatment (up to 42 months). Toxicity graded by the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0 without regard to attribution.	7.6% 6/79 • 30 days after completion of study treatment (up to 42 months). Toxicity graded by the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0 without regard to attribution.
Gastrointestinal disorders Diarrhea	18.9% 14/74 • 30 days after completion of study treatment (up to 42 months). Toxicity graded by the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0 without regard to attribution.	19.0% 15/79 • 30 days after completion of study treatment (up to 42 months). Toxicity graded by the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0 without regard to attribution.
Nervous system disorders Dizziness	14.9% 11/74 • 30 days after completion of study treatment (up to 42 months). Toxicity graded by the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0 without regard to attribution.	20.3% 16/79 • 30 days after completion of study treatment (up to 42 months). Toxicity graded by the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0 without regard to attribution.
Gastrointestinal disorders Dry mouth	1.4% 1/74 • 30 days after completion of study treatment (up to 42 months). Toxicity graded by the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0 without regard to attribution.	6.3% 5/79 • 30 days after completion of study treatment (up to 42 months). Toxicity graded by the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0 without regard to attribution.
Nervous system disorders Dysgeusia	1.4% 1/74 • 30 days after completion of study treatment (up to 42 months). Toxicity graded by the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0 without regard to attribution.	5.1% 4/79 • 30 days after completion of study treatment (up to 42 months). Toxicity graded by the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0 without regard to attribution.
Gastrointestinal disorders Dyspepsia	1.4% 1/74 • 30 days after completion of study treatment (up to 42 months). Toxicity graded by the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0 without regard to attribution.	8.9% 7/79 • 30 days after completion of study treatment (up to 42 months). Toxicity graded by the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0 without regard to attribution.
Respiratory, thoracic and mediastinal disorders Dyspnea	13.5% 10/74 • 30 days after completion of study treatment (up to 42 months). Toxicity graded by the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0 without regard to attribution.	15.2% 12/79 • 30 days after completion of study treatment (up to 42 months). Toxicity graded by the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0 without regard to attribution.
General disorders Edema limbs	25.7% 19/74 • 30 days after completion of study treatment (up to 42 months). Toxicity graded by the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0 without regard to attribution.	10.1% 8/79 • 30 days after completion of study treatment (up to 42 months). Toxicity graded by the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0 without regard to attribution.
Injury, poisoning and procedural complications Fall	10.8% 8/74 • 30 days after completion of study treatment (up to 42 months). Toxicity graded by the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0 without regard to attribution.	8.9% 7/79 • 30 days after completion of study treatment (up to 42 months). Toxicity graded by the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0 without regard to attribution.
General disorders Fatigue	40.5% 30/74 • 30 days after completion of study treatment (up to 42 months). Toxicity graded by the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0 without regard to attribution.	55.7% 44/79 • 30 days after completion of study treatment (up to 42 months). Toxicity graded by the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0 without regard to attribution.
Musculoskeletal and connective tissue disorders Flank pain	5.4% 4/74 • 30 days after completion of study treatment (up to 42 months). Toxicity graded by the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0 without regard to attribution.	5.1% 4/79 • 30 days after completion of study treatment (up to 42 months). Toxicity graded by the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0 without regard to attribution.
Gastrointestinal disorders Gastroesophageal reflux disease	5.4% 4/74 • 30 days after completion of study treatment (up to 42 months). Toxicity graded by the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0 without regard to attribution.	2.5% 2/79 • 30 days after completion of study treatment (up to 42 months). Toxicity graded by the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0 without regard to attribution.
Nervous system disorders Headache	14.9% 11/74 • 30 days after completion of study treatment (up to 42 months). Toxicity graded by the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0 without regard to attribution.	17.7% 14/79 • 30 days after completion of study treatment (up to 42 months). Toxicity graded by the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0 without regard to attribution.
Renal and urinary disorders Hematuria	2.7% 2/74 • 30 days after completion of study treatment (up to 42 months). Toxicity graded by the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0 without regard to attribution.	8.9% 7/79 • 30 days after completion of study treatment (up to 42 months). Toxicity graded by the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0 without regard to attribution.
Vascular disorders Hot flashes	20.3% 15/74 • 30 days after completion of study treatment (up to 42 months). Toxicity graded by the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0 without regard to attribution.	30.4% 24/79 • 30 days after completion of study treatment (up to 42 months). Toxicity graded by the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0 without regard to attribution.
Metabolism and nutrition disorders Hypercalcemia	8.1% 6/74 • 30 days after completion of study treatment (up to 42 months). Toxicity graded by the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0 without regard to attribution.	5.1% 4/79 • 30 days after completion of study treatment (up to 42 months). Toxicity graded by the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0 without regard to attribution.
Metabolism and nutrition disorders Hyperglycemia	21.6% 16/74 • 30 days after completion of study treatment (up to 42 months). Toxicity graded by the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0 without regard to attribution.	29.1% 23/79 • 30 days after completion of study treatment (up to 42 months). Toxicity graded by the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0 without regard to attribution.
Metabolism and nutrition disorders Hyperkalemia	14.9% 11/74 • 30 days after completion of study treatment (up to 42 months). Toxicity graded by the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0 without regard to attribution.	7.6% 6/79 • 30 days after completion of study treatment (up to 42 months). Toxicity graded by the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0 without regard to attribution.
Metabolism and nutrition disorders Hypernatremia	8.1% 6/74 • 30 days after completion of study treatment (up to 42 months). Toxicity graded by the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0 without regard to attribution.	7.6% 6/79 • 30 days after completion of study treatment (up to 42 months). Toxicity graded by the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0 without regard to attribution.
Vascular disorders Hypertension	24.3% 18/74 • 30 days after completion of study treatment (up to 42 months). Toxicity graded by the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0 without regard to attribution.	19.0% 15/79 • 30 days after completion of study treatment (up to 42 months). Toxicity graded by the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0 without regard to attribution.
Metabolism and nutrition disorders Hypoalbuminemia	8.1% 6/74 • 30 days after completion of study treatment (up to 42 months). Toxicity graded by the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0 without regard to attribution.	8.9% 7/79 • 30 days after completion of study treatment (up to 42 months). Toxicity graded by the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0 without regard to attribution.
Metabolism and nutrition disorders Hypocalcemia	9.5% 7/74 • 30 days after completion of study treatment (up to 42 months). Toxicity graded by the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0 without regard to attribution.	8.9% 7/79 • 30 days after completion of study treatment (up to 42 months). Toxicity graded by the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0 without regard to attribution.
Metabolism and nutrition disorders Hypoglycemia	9.5% 7/74 • 30 days after completion of study treatment (up to 42 months). Toxicity graded by the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0 without regard to attribution.	6.3% 5/79 • 30 days after completion of study treatment (up to 42 months). Toxicity graded by the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0 without regard to attribution.
Metabolism and nutrition disorders Hypokalemia	9.5% 7/74 • 30 days after completion of study treatment (up to 42 months). Toxicity graded by the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0 without regard to attribution.	13.9% 11/79 • 30 days after completion of study treatment (up to 42 months). Toxicity graded by the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0 without regard to attribution.
Metabolism and nutrition disorders Hyponatremia	20.3% 15/74 • 30 days after completion of study treatment (up to 42 months). Toxicity graded by the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0 without regard to attribution.	11.4% 9/79 • 30 days after completion of study treatment (up to 42 months). Toxicity graded by the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0 without regard to attribution.
Metabolism and nutrition disorders Hypophosphatemia	23.0% 17/74 • 30 days after completion of study treatment (up to 42 months). Toxicity graded by the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0 without regard to attribution.	17.7% 14/79 • 30 days after completion of study treatment (up to 42 months). Toxicity graded by the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0 without regard to attribution.
Vascular disorders Hypotension	5.4% 4/74 • 30 days after completion of study treatment (up to 42 months). Toxicity graded by the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0 without regard to attribution.	0.00% 0/79 • 30 days after completion of study treatment (up to 42 months). Toxicity graded by the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0 without regard to attribution.
Psychiatric disorders Insomnia	13.5% 10/74 • 30 days after completion of study treatment (up to 42 months). Toxicity graded by the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0 without regard to attribution.	13.9% 11/79 • 30 days after completion of study treatment (up to 42 months). Toxicity graded by the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0 without regard to attribution.
Investigations Lymphocyte count decreased	13.5% 10/74 • 30 days after completion of study treatment (up to 42 months). Toxicity graded by the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0 without regard to attribution.	25.3% 20/79 • 30 days after completion of study treatment (up to 42 months). Toxicity graded by the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0 without regard to attribution.
Psychiatric disorders Depression	6.8% 5/74 • 30 days after completion of study treatment (up to 42 months). Toxicity graded by the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0 without regard to attribution.	6.3% 5/79 • 30 days after completion of study treatment (up to 42 months). Toxicity graded by the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0 without regard to attribution.
Musculoskeletal and connective tissue disorders Musculoskeletal and connective tissue disorder - Other, specify	0.00% 0/74 • 30 days after completion of study treatment (up to 42 months). Toxicity graded by the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0 without regard to attribution.	5.1% 4/79 • 30 days after completion of study treatment (up to 42 months). Toxicity graded by the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0 without regard to attribution.
Musculoskeletal and connective tissue disorders Myalgia	2.7% 2/74 • 30 days after completion of study treatment (up to 42 months). Toxicity graded by the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0 without regard to attribution.	5.1% 4/79 • 30 days after completion of study treatment (up to 42 months). Toxicity graded by the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0 without regard to attribution.
Respiratory, thoracic and mediastinal disorders Nasal congestion	5.4% 4/74 • 30 days after completion of study treatment (up to 42 months). Toxicity graded by the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0 without regard to attribution.	10.1% 8/79 • 30 days after completion of study treatment (up to 42 months). Toxicity graded by the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0 without regard to attribution.
Gastrointestinal disorders Nausea	21.6% 16/74 • 30 days after completion of study treatment (up to 42 months). Toxicity graded by the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0 without regard to attribution.	59.5% 47/79 • 30 days after completion of study treatment (up to 42 months). Toxicity graded by the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0 without regard to attribution.
Musculoskeletal and connective tissue disorders Neck pain	5.4% 4/74 • 30 days after completion of study treatment (up to 42 months). Toxicity graded by the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0 without regard to attribution.	7.6% 6/79 • 30 days after completion of study treatment (up to 42 months). Toxicity graded by the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0 without regard to attribution.
Nervous system disorders Peripheral sensory neuropathy	2.7% 2/74 • 30 days after completion of study treatment (up to 42 months). Toxicity graded by the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0 without regard to attribution.	5.1% 4/79 • 30 days after completion of study treatment (up to 42 months). Toxicity graded by the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0 without regard to attribution.
General disorders Non-cardiac chest pain	6.8% 5/74 • 30 days after completion of study treatment (up to 42 months). Toxicity graded by the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0 without regard to attribution.	2.5% 2/79 • 30 days after completion of study treatment (up to 42 months). Toxicity graded by the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0 without regard to attribution.
General disorders Pain	16.2% 12/74 • 30 days after completion of study treatment (up to 42 months). Toxicity graded by the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0 without regard to attribution.	26.6% 21/79 • 30 days after completion of study treatment (up to 42 months). Toxicity graded by the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0 without regard to attribution.
Musculoskeletal and connective tissue disorders Pain in extremity	37.8% 28/74 • 30 days after completion of study treatment (up to 42 months). Toxicity graded by the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0 without regard to attribution.	17.7% 14/79 • 30 days after completion of study treatment (up to 42 months). Toxicity graded by the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0 without regard to attribution.
Nervous system disorders Paresthesia	5.4% 4/74 • 30 days after completion of study treatment (up to 42 months). Toxicity graded by the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0 without regard to attribution.	5.1% 4/79 • 30 days after completion of study treatment (up to 42 months). Toxicity graded by the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0 without regard to attribution.
Reproductive system and breast disorders Pelvic pain	5.4% 4/74 • 30 days after completion of study treatment (up to 42 months). Toxicity graded by the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0 without regard to attribution.	1.3% 1/79 • 30 days after completion of study treatment (up to 42 months). Toxicity graded by the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0 without regard to attribution.
Investigations Platelet count decreased	16.2% 12/74 • 30 days after completion of study treatment (up to 42 months). Toxicity graded by the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0 without regard to attribution.	11.4% 9/79 • 30 days after completion of study treatment (up to 42 months). Toxicity graded by the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0 without regard to attribution.
Respiratory, thoracic and mediastinal disorders Productive cough	4.1% 3/74 • 30 days after completion of study treatment (up to 42 months). Toxicity graded by the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0 without regard to attribution.	5.1% 4/79 • 30 days after completion of study treatment (up to 42 months). Toxicity graded by the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0 without regard to attribution.
Skin and subcutaneous tissue disorders Rash maculo-papular	2.7% 2/74 • 30 days after completion of study treatment (up to 42 months). Toxicity graded by the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0 without regard to attribution.	6.3% 5/79 • 30 days after completion of study treatment (up to 42 months). Toxicity graded by the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0 without regard to attribution.
Infections and infestations Sinusitis	5.4% 4/74 • 30 days after completion of study treatment (up to 42 months). Toxicity graded by the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0 without regard to attribution.	2.5% 2/79 • 30 days after completion of study treatment (up to 42 months). Toxicity graded by the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0 without regard to attribution.
Skin and subcutaneous tissue disorders Skin and subcutaneous tissue disorders - Other, specify	6.8% 5/74 • 30 days after completion of study treatment (up to 42 months). Toxicity graded by the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0 without regard to attribution.	5.1% 4/79 • 30 days after completion of study treatment (up to 42 months). Toxicity graded by the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0 without regard to attribution.
Infections and infestations Skin infection	2.7% 2/74 • 30 days after completion of study treatment (up to 42 months). Toxicity graded by the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0 without regard to attribution.	5.1% 4/79 • 30 days after completion of study treatment (up to 42 months). Toxicity graded by the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0 without regard to attribution.
Respiratory, thoracic and mediastinal disorders Upper respiratory infection	12.2% 9/74 • 30 days after completion of study treatment (up to 42 months). Toxicity graded by the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0 without regard to attribution.	11.4% 9/79 • 30 days after completion of study treatment (up to 42 months). Toxicity graded by the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0 without regard to attribution.
Renal and urinary disorders Urinary frequency	12.2% 9/74 • 30 days after completion of study treatment (up to 42 months). Toxicity graded by the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0 without regard to attribution.	20.3% 16/79 • 30 days after completion of study treatment (up to 42 months). Toxicity graded by the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0 without regard to attribution.
Renal and urinary disorders Urinary incontinence	6.8% 5/74 • 30 days after completion of study treatment (up to 42 months). Toxicity graded by the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0 without regard to attribution.	10.1% 8/79 • 30 days after completion of study treatment (up to 42 months). Toxicity graded by the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0 without regard to attribution.
Infections and infestations Urinary tract infection	1.4% 1/74 • 30 days after completion of study treatment (up to 42 months). Toxicity graded by the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0 without regard to attribution.	8.9% 7/79 • 30 days after completion of study treatment (up to 42 months). Toxicity graded by the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0 without regard to attribution.
Gastrointestinal disorders Vomiting	9.5% 7/74 • 30 days after completion of study treatment (up to 42 months). Toxicity graded by the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0 without regard to attribution.	22.8% 18/79 • 30 days after completion of study treatment (up to 42 months). Toxicity graded by the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0 without regard to attribution.
Investigations Weight gain	10.8% 8/74 • 30 days after completion of study treatment (up to 42 months). Toxicity graded by the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0 without regard to attribution.	3.8% 3/79 • 30 days after completion of study treatment (up to 42 months). Toxicity graded by the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0 without regard to attribution.
Investigations Weight loss	12.2% 9/74 • 30 days after completion of study treatment (up to 42 months). Toxicity graded by the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0 without regard to attribution.	13.9% 11/79 • 30 days after completion of study treatment (up to 42 months). Toxicity graded by the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0 without regard to attribution.
Investigations White blood cell decreased	5.4% 4/74 • 30 days after completion of study treatment (up to 42 months). Toxicity graded by the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0 without regard to attribution.	8.9% 7/79 • 30 days after completion of study treatment (up to 42 months). Toxicity graded by the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0 without regard to attribution.

Additional Information

Theodore Karrison, PhD

University of Chicago

Phone: (773) 702-9326

Email: tkarrison@health.bsd.uchicago.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place

Restriction type: LTE60