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VELIA: Veliparib With Carboplatin and Paclitaxel and as Continuation Maintenance Therapy in Adults With Newly Diagnosed Stage III or IV, High-grade Serous, Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Cancer

Sponsor
AbbVie (Industry)
Overall Status
Active, not recruiting
CT.gov ID
NCT02470585
Collaborator
Gynecologic Oncology Group;Australia New Zealand Gynaecological Oncology Group (Other)
1,140
Enrollment
210
Locations
3
Arms
137.3
Anticipated Duration (Months)
5.4
Patients Per Site
0
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The primary objective of the study was to evaluate whether progression-free survival (PFS) was prolonged with the addition of veliparib to standard platinum-based chemotherapy (carboplatin/paclitaxel [C/P]) and continued as maintenance therapy compared with chemotherapy alone.

Condition or Disease Intervention/Treatment Phase
Phase 3

Detailed Description

Participants were randomized in a 1:1:1 ratio to one of three arms. Randomization in the entire population was stratified according to the timing of surgery and residual disease status (any residual disease after primary surgery vs. no residual disease after primary surgery vs. interval surgery) and the paclitaxel schedule (weekly vs. every 3 -weeks), stage of disease (III vs. IV), geographic region (Japan vs. North America and rest of world [ROW]), and germline breast cancer susceptibility gene (BRCA) mutation status (positive versus negative or Unknown).

Cytoreductive surgery could be performed before randomization and the initiation of study treatment (primary) or after 3 cycles of study treatment (interval). The weekly or every-3-week paclitaxel schedule and the choice of primary or interval cytoreductive surgery were determined at the discretion of the investigator.

The primary objective was evaluated in the BRCA-deficient cohort, participants with homologous recombination deficiency (HRD), and the intention-to-treat (ITT) population. These populations were sequentially inclusive, with the HRD population including the BRCA-deficient population, and the ITT population including the HRD and BRCA-deficient populations. The BRCA-deficient population was defined as participants with either a germline (gBRCA) and/or tissue-based (tBRCA) deleterious or suspected deleterious mutation in BRCA1 or BRCA2 confirmed by centralized testing. The HRD population was defined as participants with HRD tumors based on HRD score or presence of a deleterious or suspected deleterious mutation in BRCA1 or BRCA2 as determined by centralized testing.

Study Design

Study Type:
Interventional
Actual Enrollment :
1140 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Treatment
Official Title:
A Phase 3 Placebo-Controlled Study of Carboplatin/Paclitaxel With or Without Concurrent and Continuation Maintenance Veliparib (PARP Inhibitor) in Subjects With Previously Untreated Stages III or IV High-Grade Serous Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Cancer
Actual Study Start Date :
Jun 29, 2015
Actual Primary Completion Date :
May 3, 2019
Anticipated Study Completion Date :
Dec 8, 2026

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Placebo + Carboplatin + Paclitaxel -> Placebo

Participants will receive placebo to veliparib orally twice a day in combination with carboplatin/paclitaxel for six 21-day cycles followed by placebo monotherapy continuous dosing for an additional thirty 21-day cycles.

Drug: Paclitaxel
Administered by intravenous infusion, either 80 mg/m² of body-surface area (BSA) on Days 1, 8, and 15 of each 21-day cycle (weekly dosing), or 175 mg/m² of BSA on Day 1 of each 21-day cycle (3-week dosing).

Drug: Carboplatin
Administered by intravenous infusion at an area under the curve (AUC) of 6 mg/mL/min every 3 weeks.

Other: Placebo to Veliparib
Capsules for oral administration
Experimental: Veliparib + Carboplatin + Paclitaxel -> Placebo

Participants will receive 150 mg veliparib orally twice a day in combination with carboplatin/paclitaxel for six 21-day cycles followed by placebo monotherapy continuous dosing for an additional thirty 21-day cycles.

Drug: Veliparib
Capsules for oral administration
Other Names:
  • ABT-888

    • Drug: Paclitaxel
    Administered by intravenous infusion, either 80 mg/m² of body-surface area (BSA) on Days 1, 8, and 15 of each 21-day cycle (weekly dosing), or 175 mg/m² of BSA on Day 1 of each 21-day cycle (3-week dosing).

    Drug: Carboplatin
    Administered by intravenous infusion at an area under the curve (AUC) of 6 mg/mL/min every 3 weeks.

    Other: Placebo to Veliparib
    Capsules for oral administration
    Experimental: Veliparib + Carboplatin + Paclitaxel -> Veliparib

    Participants will receive 150 mg veliparib orally twice a day in combination with carboplatin/paclitaxel for six 21-day cycles followed by 300/400 mg veliparib monotherapy orally twice a day for an additional thirty 21-day cycles.

    Drug: Veliparib
    Capsules for oral administration
    Other Names:
  • ABT-888

    • Drug: Paclitaxel
    Administered by intravenous infusion, either 80 mg/m² of body-surface area (BSA) on Days 1, 8, and 15 of each 21-day cycle (weekly dosing), or 175 mg/m² of BSA on Day 1 of each 21-day cycle (3-week dosing).

    Drug: Carboplatin
    Administered by intravenous infusion at an area under the curve (AUC) of 6 mg/mL/min every 3 weeks.

    Outcome Measures

    Primary Outcome Measures

    1. Progression-Free Survival (PFS) in the BRCA-deficient Population [From randomization until the primary analysis data cut-off date of 03 May 2019, the median duration of follow-up was 28 months.]

      PFS was defined as the time from the date that the participant was randomized to the date the participant experienced an event of disease progression, according to Response Evaluation Criteria In Solid Tumors (RECIST) criteria version 1.1 (as determined by the investigator) or to the date of death if disease progression was not reached. If the participant did not have an event of disease progression or death prior to the analysis cut-off date, the participant's data were censored at the date of their last evaluable disease assessment. PFS was estimated using the Kaplan-Meier method. The analysis of PFS occurred when the protocol-specified number of PFS events was reached. Progressive Disease (PD): At least a 20% increase in the size of target lesions, compared with the smallest size recorded since the treatment started, and an absolute increase of ≥ 5 mm, or unequivocal progression of existing non-target lesions or the appearance of new lesions.

    2. Progression-Free Survival (PFS) in the Homologous Recombination Deficiency Cohort [From randomization until the primary analysis data cut-off date of 03 May 2019, the median duration of follow-up was 28 months.]

      PFS was defined as the time from the date that the participant was randomized to the date the participant experienced an event of disease progression, according to Response Evaluation Criteria In Solid Tumors (RECIST) criteria version 1.1 (as determined by the investigator) or to the date of death if disease progression was not reached. If the participant did not have an event of disease progression or death, the participant's data were censored at the date of their last evaluable disease assessment. PFS was estimated using the Kaplan-Meier method. The primary analysis of PFS occurred when the protocol-specified number of PFS events was reached and was performed in 3 sequentially inclusive populations. Progressive Disease (PD): At least a 20% increase in the size of target lesions, compared with the smallest size recorded since the treatment started, and an absolute increase of ≥ 5 mm, or unequivocal progression of existing non-target lesions or the appearance of new lesions. .

    3. Progression-Free Survival (PFS) in the Intention-to-treat Population [From randomization until the primary analysis data cut-off date of 03 May 2019, the median duration of follow-up was 28 months.]

      PFS was defined as the time from the date that the participant was randomized to the date the participant experienced an event of disease progression, according to Response Evaluation Criteria In Solid Tumors (RECIST) criteria version 1.1 (as determined by the investigator) or to the date of death (all causes of mortality) if disease progression was not reached. If the participant did not have an event of disease progression according to RECIST criteria (as or death, the participant's data were censored at the date of their last evaluable disease assessment. PFS was estimated using the Kaplan-Meier method. Progressive Disease (PD): At least a 20% increase in the size of target lesions, compared with the smallest size recorded since the treatment started, and an absolute increase of ≥ 5 mm, or unequivocal progression of existing non-target lesions or the appearance of new lesions. The primary analysis of PFS occurred when the protocol-specified number of PFS events was reached.

    Secondary Outcome Measures

    1. Overall Survival (OS) [Approximately 8 years from randomization.]

      OS is defined as the time from the day the participant was randomized to the date of death. All events of death will be included, regardless of whether the event occurs while the participant is still taking study drug, or after discontinuation of study drug. If a participant has not died, then the data will be censored at the date the participant is last known to be alive. The final analysis of OS will occur when the pre-specified number of events has occurred in the ITT and HRD populations.

    2. Change From Baseline in Disease Related Symptom (DRS) Score in the BRCA-mutation Population [Baseline and Day 1 of Cycles 3, 5, 7, 9, 11, 13, 15, 17, 19, 21, 23, 25, 27, 29, 31, 33, and 35]

      The Disease Related Symptom score is a subset of the National Comprehensive Cancer Network Functional Assessment of Cancer Therapy Ovarian Symptom Index-18 (NFOSI-18), which evaluates nine symptoms related to ovarian cancer. The NFOSI-18 DRS score ranges from 0 to 36, with higher scores indicating a lower burden of symptoms and a score of 0 being severely symptomatic. A 3-point difference was defined as clinically meaningful. A positive change from Baseline indicates improvement. Change from Baseline was calculated using a used a mixed-model for repeated measures (MMRM) with treatment, stratification factors of residual disease and stage of disease, time point and treatment-by-time point interaction as fixed effect factors, and Baseline DRS score as a covariate. DRS was not included in the fixed-sequence testing procedure.

    3. Change From Baseline in Disease Related Symptom (DRS) Score in the HRD Population [Baseline and Day 1 of Cycles 3, 5, 7, 9, 11, 13, 15, 17, 19, 21, 23, 25, 27, 29, 31, 33, and 35]

      The Disease Related Symptom score is a subset of the National Comprehensive Cancer Network Functional Assessment of Cancer Therapy Ovarian Symptom Index-18 (NFOSI-18), which evaluates nine symptoms related to ovarian cancer. The NFOSI-18 DRS score ranges from 0 to 36, with higher scores indicating a lower burden of symptoms and a score of 0 being severely symptomatic. A 3-point difference was defined as clinically meaningful. A positive change from Baseline indicates improvement. Change from Baseline was calculated using a used a mixed-model for repeated measures (MMRM) with treatment, stratification factors of residual disease and stage of disease, time point and treatment-by-time point interaction as fixed effect factors, and Baseline DRS score as a covariate. DRS was not included in the fixed-sequence testing procedure.

    4. Change From Baseline in Disease Related Symptom (DRS) Score in the ITT Population [Baseline and Day 1 of Cycles 3, 5, 7, 9, 11, 13, 15, 17, 19, 21, 23, 25, 27, 29, 31, 33, and 35]

      The Disease Related Symptom score is a subset of the National Comprehensive Cancer Network Functional Assessment of Cancer Therapy Ovarian Symptom Index-18 (NFOSI-18), which evaluates nine symptoms related to ovarian cancer. The NFOSI-18 DRS score ranges from 0 to 36, with higher scores indicating a lower burden of symptoms and a score of 0 being severely symptomatic. A 3-point difference was defined as clinically meaningful. A positive change from Baseline indicates improvement. Change from Baseline was calculated using a used a mixed-model for repeated measures (MMRM) with treatment, stratification factors of residual disease, stage of disease, choice of paclitaxel dosing regimen and BRCA-deficient status, time point and treatment-by-time point interaction as fixed effect factors, and Baseline DRS score as a covariate. DRS was not included in the fixed-sequence testing procedure.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    1. Histologic diagnosis of International Federation of Gynecology and Obstetrics (FIGO) Stage III or IV epithelial ovarian, fallopian tube, or primary peritoneal carcinoma, with the appropriate tissue available for histologic evaluation.

    2. High-grade serous adenocarcinoma

    3. Willing to undergo testing for gBRCA.

    4. Adequate hematologic, renal, and hepatic function.

    5. Neuropathy (sensory and motor) less than or equal to Grade 1.

    6. Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2.

    7. Participants who undergo primary cytoreductive surgery must be entered between 1 and 12 weeks after surgery. Participants undergoing interval surgery must have a tumor sample confirming the histological diagnosis prior to enrollment.

    8. Participants with measurable disease or non-measurable disease are eligible. Participants may or may not have cancer-related symptoms.

    9. Participant has one of the following available for pharmacodynamic analyses including somatic BRCA testing: Archived diagnostic formalin-fixed paraffin embedded (FFPE) tumor tissue; or tumor tissue biopsy collected prior to Cycle 1 Day 1.

    Exclusion Criteria:

    1. Endometrioid adenocarcinoma, carcinosarcoma, undifferentiated carcinoma, mixed epithelial adenocarcinoma, adenocarcinoma not otherwise specified, mucinous adenocarcinoma, clear cell adenocarcinoma, low-grade serous adenocarcinoma, or malignant Brenner's tumor.

    2. Participants with synchronous primary endometrial cancer, or a past history of endometrial cancer unless all of the following conditions are met: endometrial cancer stage not greater than IA, no vascular or lymphatic invasion, no poorly differentiated subtypes including serous, clear cell, or other FIGO grade 3 lesions.

    3. Participants with any evidence of other invasive malignancy being present within the last 3 years (with the exception of non-melanoma skin cancer). Participants are also excluded if their previous cancer treatment contraindicates this protocol's therapy.

    4. Received prior radiotherapy to any portion of the abdominal cavity or pelvis.

    5. Received prior chemotherapy for any abdominal or pelvic tumor.

    6. Clinically significant uncontrolled condition(s).

    7. Known history of allergic reaction to Cremophor-paclitaxel, carboplatin, Azo-Colourant Tartrazine (also known as FD&C Yellow 5 or E102), Azo-Colourant Orange Yellow-S (also known as FD&C Yellow 6 or E110) or known contraindications to any study supplied drug.

    8. History or evidence upon physical examination of central nervous system (CNS) disease, including primary brain tumor, any brain metastases, or history of cerebrovascular accident (CVA, stroke), transient ischemic attack (TIA) within 6 months of Cycle 1 Day

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 University of Alabama at Birmingham - Main /ID# 138087 Birmingham Alabama United States 35233
    2 Tennessee Valley Gyn-Onc /ID# 139548 Huntsville Alabama United States 35805
    3 University of South Alabama /ID# 138091 Mobile Alabama United States 36604-3302
    4 Alaska Womens Cancer Care /ID# 138231 Anchorage Alaska United States 99508-4684
    5 Arizona Oncology Associates, PC-HOPE /ID# 142002 Tucson Arizona United States 85711-2701
    6 Arizona Oncology Associates, PC-HOPE /ID# 143805 Tucson Arizona United States 85711-2701
    7 Arizona Oncology Associates, PC-HOPE /ID# 143806 Tucson Arizona United States 85711-2701
    8 Arizona Oncology Associates, PC-HOPE /ID# 143808 Tucson Arizona United States 85711-2701
    9 University of Arizona Cancer Center - North Campus /ID# 138084 Tucson Arizona United States 85719-1478
    10 University of Arizona Cancer Center - North Campus /ID# 139495 Tucson Arizona United States 85719-1478
    11 University of Arkansas for Medical Sciences /ID# 138253 Little Rock Arkansas United States 72205
    12 John Muir Medical Center /ID# 139618 Concord California United States 94520
    13 Ucsd /Id# 140323 La Jolla California United States 92093
    14 Long Beach Memorial Medical Ct /ID# 147526 Long Beach California United States 90806
    15 Kaiser Permanente /ID# 141305 Los Angeles California United States 90027
    16 University of California, Los Angeles /ID# 138179 Los Angeles California United States 90095
    17 Medical Oncology Care Assoc /ID# 139498 Orange California United States 92868-4304
    18 Univ CA, Irvine Med Ctr /ID# 139613 Orange California United States 92868
    19 UC Davis Comprehensive Cancer Center - Main /ID# 144439 Sacramento California United States 95817
    20 California Pacific Medical Ctr /ID# 138177 San Francisco California United States 94115
    21 Kaiser Permanente - San Francisco /ID# 142051 San Francisco California United States 94115
    22 Univ California, San Francisco /ID# 138178 San Francisco California United States 94143-2204
    23 Kaiser Permanente-Santa Clara /ID# 142053 Santa Clara California United States 95051-5173
    24 Stanford University School of Med /ID# 139450 Stanford California United States 94305-2200
    25 Palo Alto Medical Foundation /ID# 139452 Sunnyvale California United States 94086
    26 Kaiser Permanente Medical Ctr-Vallejo /ID# 139492 Vallejo California United States 94589-2441
    27 Kaiser Permanente- Walnut Creek /ID# 142052 Walnut Creek California United States 94596
    28 Kaiser Permanente, Waterpark III Institute for Health Research /ID# 139499 Aurora Colorado United States 80014
    29 Univ of Colorado Cancer Center /ID# 138016 Aurora Colorado United States 80045
    30 Hartford Healthcare /ID# 138184 New Britain Connecticut United States 6053
    31 Yale University /ID# 138056 New Haven Connecticut United States 06510
    32 University of Miami /ID# 139457 Miami Florida United States 33136
    33 Women's Cancer Associates /ID# 140321 Saint Petersburg Florida United States 33701
    34 Sarasota Memorial Health Care /ID# 138180 Sarasota Florida United States 34239
    35 Moffitt Cancer Center /ID# 138061 Tampa Florida United States 33612-9416
    36 Georgia Regents University /ID# 138085 Augusta Georgia United States 30912
    37 IACT Health /ID# 138058 Columbus Georgia United States 31904-8946
    38 Memorial Health Univ Med Ctr /ID# 138019 Savannah Georgia United States 31404
    39 St. Joseph's/Candler /ID# 138090 Savannah Georgia United States 31405
    40 The Queens Medical Center /ID# 141709 Honolulu Hawaii United States 96813
    41 Kapiolani Medical Center /ID# 140319 Honolulu Hawaii United States 96826
    42 Rush University Medical Center /ID# 143491 Chicago Illinois United States 60612
    43 University of Chicago /ID# 139612 Chicago Illinois United States 60637-1443
    44 NorthShore University HealthSystem - Evanston Hospital /ID# 139451 Evanston Illinois United States 60201
    45 Sharma, Hinsdale, IL /ID# 140326 Hinsdale Illinois United States 60521
    46 Advocate Lutheran General Hosp /ID# 139489 Park Ridge Illinois United States 60068
    47 Indiana Univ School Medicine /ID# 139610 Indianapolis Indiana United States 46202
    48 Saint Vincent /ID# 139537 Indianapolis Indiana United States 46260
    49 McFarland Clinic, PC /ID# 139455 Ames Iowa United States 50010
    50 University of Iowa Hospitals and Clinics /ID# 138082 Iowa City Iowa United States 52242
    51 Univ Kansas Med Ctr /ID# 140322 Kansas City Kansas United States 66160
    52 Baptist Health Lexington /ID# 139542 Lexington Kentucky United States 40503
    53 University of Kentucky Chandler Medical Center /ID# 138060 Lexington Kentucky United States 40536
    54 Norton Cancer Institute /ID# 139567 Louisville Kentucky United States 40202-3700
    55 MMP Women's Health /ID# 139544 Portland Maine United States 04102
    56 Greater Baltimore Medical Ctr /ID# 138049 Baltimore Maryland United States 21204
    57 Sinai Hospital of Baltimore /ID# 141306 Baltimore Maryland United States 21215
    58 Weinberg Cancer Inst Franklin /ID# 138235 Rossville Maryland United States 21237
    59 Baystate Medical Center /ID# 139456 Springfield Massachusetts United States 01199
    60 UMass Memorial Medical Center /ID# 139458 Worcester Massachusetts United States 01655
    61 Wayne State University /ID# 139601 Detroit Michigan United States 48201-2013
    62 Henry Ford Health System /ID# 139536 Detroit Michigan United States 48202
    63 William Beaumont Hospital /ID# 139550 Royal Oak Michigan United States 48073-6710
    64 Mayo Clinic - Rochester /ID# 139565 Rochester Minnesota United States 55905-0001
    65 Mmcorc /Id# 139534 Saint Louis Park Minnesota United States 55416
    66 St. Dominic Hospital /ID# 138241 Jackson Mississippi United States 39216
    67 Ellis Fischel Cancer Center /ID# 139571 Columbia Missouri United States 65212-1000
    68 Washington University-School of Medicine /ID# 138089 Saint Louis Missouri United States 63110
    69 Cancer Research For the Ozarks /ID# 139538 Springfield Missouri United States 65804
    70 Ferrell-Duncan Clinic /ID# 143484 Springfield Missouri United States 65807
    71 Nebraska Methodist Hospital /ID# 139600 Omaha Nebraska United States 68114
    72 Womens Cancer Center of Nevada /ID# 138092 Las Vegas Nevada United States 89169
    73 Renown Regional Medical Center /ID# 138237 Reno Nevada United States 89502
    74 Dartmouth-Hitchcock Medical Center /ID# 139502 Lebanon New Hampshire United States 03756
    75 MD Anderson Cancer Ctr at Coop /ID# 139616 Camden New Jersey United States 08103
    76 Hackensack Univ Med Ctr /ID# 143776 Hackensack New Jersey United States 07601
    77 University of New Mexico /ID# 144220 Albuquerque New Mexico United States 87102
    78 SW Gynecologic Oncology Assoc /ID# 147097 Albuquerque New Mexico United States 87106
    79 Women's Cancer Care Associates /ID# 138234 Albany New York United States 12208
    80 Montefiore Medical Center /ID# 139585 Bronx New York United States 10461
    81 SUNY Downstate Medical Center /ID# 139533 Brooklyn New York United States 11203
    82 Roswell Park Comprehensive Cancer Center /ID# 138052 Buffalo New York United States 14263
    83 Northwell Health /ID# 139572 Lake Success New York United States 11042
    84 Icahn School of Med Mt. Sinai /ID# 139617 New York New York United States 10029
    85 Columbia University Medical Center /ID# 138252 New York New York United States 10032-3729
    86 Memorial Sloan Kettering Cancer Center /ID# 138017 New York New York United States 10065-6007
    87 Memorial Sloan Kettering Cancer Center /ID# 154464 New York New York United States 10065-6007
    88 SUNY Upstate Medical University - Downtown /ID# 139513 Syracuse New York United States 13210
    89 Hope Womens Cancer Centers /ID# 139614 Asheville North Carolina United States 28816
    90 Univ NC Chapel Hill /ID# 138547 Chapel Hill North Carolina United States 27514-4220
    91 Atrium Health Carolinas Medical Center /ID# 139568 Charlotte North Carolina United States 28203
    92 Presbyterian Cancer Center /ID# 139590 Charlotte North Carolina United States 28204
    93 Duke University Medical Center /ID# 138048 Durham North Carolina United States 27710-3000
    94 Wake Forest Baptist Medical Center /ID# 139588 Winston-Salem North Carolina United States 27157-0001
    95 University of Cincinnati /ID# 139619 Cincinnati Ohio United States 45267-0585
    96 Univ Hosp Cleveland /ID# 139615 Cleveland Ohio United States 44106
    97 Fairview Hospital /ID# 144403 Cleveland Ohio United States 44111
    98 Cleveland Clinic Main Campus /ID# 139501 Cleveland Ohio United States 44195
    99 The Ohio State University - Columbus /ID# 138053 Columbus Ohio United States 43210
    100 Columbus NCORP /ID# 139587 Columbus Ohio United States 43215
    101 Womens Cancer Center /ID# 138062 Kettering Ohio United States 45429-1226
    102 Hillcrest Hospital /ID# 144404 Mayfield Heights Ohio United States 44124
    103 Univ Oklahoma HSC /ID# 138020 Oklahoma City Oklahoma United States 73104
    104 Oklahoma Cancer Specialists /ID# 138059 Tulsa Oklahoma United States 74146
    105 Willamette Valley Cancer Institute /ID# 140318 Eugene Oregon United States 97401-6043
    106 Kaiser Permanente, NW /ID# 138249 Portland Oregon United States 97227
    107 Abington Memorial Hospital /ID# 138086 Abington Pennsylvania United States 19001
    108 University of Pennsylvania /ID# 140079 Philadelphia Pennsylvania United States 19104-5502
    109 Thomas Jefferson University /ID# 138239 Philadelphia Pennsylvania United States 19107-4414
    110 Fox Chase Cancer Center /ID# 149479 Philadelphia Pennsylvania United States 19111
    111 University of Pittsburgh MC /ID# 138054 Pittsburgh Pennsylvania United States 15260
    112 Reading Hospital /ID# 138057 Reading Pennsylvania United States 19611
    113 Women and Infants Hospital /ID# 138083 Providence Rhode Island United States 02905
    114 Medical University of South Carolina /ID# 138181 Charleston South Carolina United States 29425
    115 Sanford Research/USD /ID# 139624 Sioux Falls South Dakota United States 57104-8805
    116 Chattanoogas Program in Womens /ID# 139545 Chattanooga Tennessee United States 37403
    117 Texas Oncology - Austin Central /ID# 143817 Austin Texas United States 78731
    118 Texas Oncology - South Austin /ID# 143818 Austin Texas United States 78745
    119 Texas Oncology - Bedford /ID# 143814 Bedford Texas United States 76022
    120 Texas Oncology - Medical City Dallas /ID# 143809 Dallas Texas United States 75230
    121 Texas Oncology - Medical City Dallas /ID# 143812 Dallas Texas United States 75230
    122 Texas Oncology - Forth Worth /ID# 143811 Fort Worth Texas United States 76104-2150
    123 Houston Methodist Hospital - Scurlock Tower /ID# 138232 Houston Texas United States 77030
    124 Memorial Hermann Hospital /ID# 138238 Houston Texas United States 77030
    125 Texas Oncology - The Woodlands /ID# 142003 The Woodlands Texas United States 77380
    126 Texas Oncology - Tyler /ID# 143810 Tyler Texas United States 75702
    127 University of Utah /ID# 138250 Salt Lake City Utah United States 84112-5500
    128 University of Vermont Medical Center /ID# 138251 Burlington Vermont United States 05401-1473
    129 University of Virginia /ID# 138088 Charlottesville Virginia United States 22908
    130 Carilion Roanoke Memorial Hosp /ID# 139602 Roanoke Virginia United States 24014
    131 Skagit Valley Medical Center /ID# 139586 Mount Vernon Washington United States 98273
    132 MultiCare Regional Cancer Ctr /ID# 149872 Puyallup Washington United States 93872
    133 Multicare Institute for Research and Innovation /ID# 143485 Tacoma Washington United States 98405
    134 HSHS St. Vincent Hospital /ID# 139453 Green Bay Wisconsin United States 54301
    135 Froedtert & the Medical College of Wisconsin /ID# 139449 Milwaukee Wisconsin United States 53226-3522
    136 Coffs Harbour Health Campus /ID# 145132 Coffs Harbour New South Wales Australia 2450
    137 Gosford Hospital /ID# 145299 Gosford New South Wales Australia 2250
    138 St George Hospital /ID# 145138 Kogarah New South Wales Australia 2217
    139 Newcastle Private Hospital /ID# 145834 Lambton Heights New South Wales Australia 2305
    140 The Prince of Wales Hospital /ID# 145134 Randwick New South Wales Australia 2031
    141 Northern Cancer Institute /ID# 145681 St Leonards New South Wales Australia 2065
    142 Calvary Mater Newcastle /ID# 145139 Waratah New South Wales Australia 2298
    143 Westmead Hospital /ID# 145137 Westmead New South Wales Australia 2145
    144 Southern Medical Day Care Ctr /ID# 145133 Wollongong New South Wales Australia 2500
    145 The Townsville Hospital /ID# 149163 Douglas Queensland Australia 4814
    146 Royal Brisbane and Women's Hospital /ID# 145135 Herston Queensland Australia 4029
    147 Icon Cancer Centre /ID# 148208 South Brisbane Queensland Australia 4101
    148 Mater Misericordiae Limited /ID# 145682 South Brisbane Queensland Australia 4101
    149 Royal Adelaide Hospital /ID# 150071 Adelaide South Australia Australia 5000
    150 Monash Health /ID# 145297 Clayton Victoria Australia 3168
    151 Cabrini Health /ID# 145142 Malvern Victoria Australia 3144
    152 Royal Womens Hospital /ID# 145136 Parkville Victoria Australia 3052
    153 Sir Charles Gairdner Hospital /ID# 145140 Nedlands Western Australia Australia 6009
    154 St. John of God Subiaco Hosp /ID# 147742 Subiaco Western Australia Australia 6008
    155 Hc Ufmg /Id# 137156 Belo Horizonte Minas Gerais Brazil 30130-100
    156 Hospital Sao Lucas da PUCRS /ID# 137157 Porto Alegre Rio Grande Do Sul Brazil 90610-000
    157 Hospital de Cancer de Barretos /ID# 137121 Barretos Sao Paulo Brazil 14784-400
    158 Centro de Referencia da Saude da Mulher - Hospital Perola Byington /ID# 137120 São Paulo Sao Paulo Brazil 01317-000
    159 Instituto Nacional de Câncer José de Alencar Gomes da Silva (INCA) /ID# 137155 Rio de Janeiro Brazil 20231-050
    160 Vejle Sygehus /ID# 137262 Vejle Syddanmark Denmark 7100
    161 Regionshospitalet Herning /ID# 137260 Herning Denmark 7400
    162 Rambam Health Care Campus /ID# 137434 Haifa Israel 3109601
    163 The Lady Davis Carmel MC /ID# 137537 Haifa Israel 3436212
    164 Shaare Zedek Medical Center /ID# 137435 Jerusalem Israel 91031
    165 Meir Medical Center /ID# 139397 Kfar Saba Israel 4428164
    166 Sheba Medical Center /ID# 137436 Ramat Gan Israel 5262100
    167 Kaplan Medical Center /ID# 137536 Rehovot Israel 76100
    168 Aichi Cancer Center Hospital /ID# 148398 Nagoya-shi Aichi Japan 464-8681
    169 National Hospital Organization Kyushu Cancer Center /ID# 149133 Fukuoka-shi Fukuoka Japan 811-1395
    170 Kurume University Hospital /ID# 148697 Kurume-shi Fukuoka Japan 830-0011
    171 Iwate Medical University Hospital /ID# 147721 Shiwa-gun Iwate Japan 028-3695
    172 Kumamoto University Hospital /ID# 154169 Kumamoto-shi Kumamoto Japan 860-8556
    173 Mie University Hospital /ID# 149169 Tsu-shi Mie Japan 514-8507
    174 Tohoku University Hospital /ID# 149818 Sendai-shi Miyagi Japan 980-8574
    175 Niigata University Medical & Dental Hospital /ID# 149488 Niigata-shi Niigata Japan 951-8520
    176 Kindai University Hospital /ID# 154947 Osaka-sayama Osaka Japan 5898511
    177 Shizuoka Cancer Center /ID# 147723 Sunto-gun Shizuoka Japan 411-8777
    178 The Cancer Institute Hosp JFCR /ID# 148436 Koto-ku Tokyo Japan 135-8550
    179 Keio University Hospital /ID# 148326 Shinjuku-ku Tokyo Japan 160-8582
    180 Yamagata University Hospital /ID# 153646 Yamagata-shi Yamagata Japan 990-9585
    181 Hyogo Cancer Center /ID# 148327 Akashi Japan 673-8558
    182 Kansai Rosai Hospital /ID# 149237 Amagasaki Japan 660-8511
    183 The Jikei Univ. Kashiwa Hosp. /ID# 149238 Kashiwa-shi Japan 277-0004
    184 St. Marianna Univ Hospital /ID# 149327 Kawasaki Japan 216-8511
    185 NHO Kure Medical Center and Ch /ID# 148569 Kure Japan 737-0023
    186 Shikoku Cancer Center /ID# 148382 Matsuyama Japan 791-0280
    187 Osaka International Cancer Institute /ID# 150778 Osaka Japan 541-8567
    188 Hokkaido Cancer Center /ID# 148570 Sapporo Japan 003-0804
    189 The Jikei University Hospital /ID# 148691 Tokyo Japan 105-8461
    190 National Cancer Center /ID# 139404 Goyang Gyeonggido Korea, Republic of 10408
    191 Korea University Anam Hospital /ID# 136908 성북구 Gyeonggido Korea, Republic of 02841
    192 Gangnam Severance Hospital /ID# 136835 Seoul Seoul Teugbyeolsi Korea, Republic of 06273
    193 Samsung Medical Center /ID# 136834 Seoul Seoul Teugbyeolsi Korea, Republic of 06351
    194 Seoul National University Hospital /ID# 136909 Seoul Korea, Republic of 03080
    195 Asan Medical Center /ID# 136836 Seoul Korea, Republic of 05505
    196 Auckland City Hospital /ID# 145123 Auckland New Zealand 1023
    197 Uniwersyteckie C. Kliniczne /ID# 138021 Gdańsk Poland 80-214
    198 Hospital Duran i Reynals /ID# 137298 L'Hospitalet de Llobregat Barcelona Spain 08907
    199 Hospital Univ Vall d'Hebron /ID# 137297 Barcelona Spain 08035
    200 Hospital Clinic de Barcelona /ID# 137300 Barcelona Spain 08036
    201 Hospital Clin Univ San Carlos /ID# 137402 Madrid Spain 28040
    202 Hosp Univ 12 de Octubre /ID# 137299 Madrid Spain 28041
    203 Hosp Univ Madrid Sanchinarro /ID# 137414 Madrid Spain 28050
    204 Fundacion Inst Valenciano Onc /ID# 137403 Valencia Spain 46009
    205 Norfolk and Norwich Univ Hosp /ID# 137969 Norwich Norfolk United Kingdom NR4 7UY
    206 Beatson west of scotland cancer center /ID# 137965 Glasgow Scotland United Kingdom G12 0YN
    207 Ninewells Hospital /ID# 137967 Dundee United Kingdom DD1 9SY
    208 James Paget University Hosp /ID# 137970 Great Yarmouth United Kingdom NR31 6LA
    209 Imanova Limited, Hammersmith Hospital /ID# 137966 London United Kingdom W12 0HS
    210 Oxford Univ Hosp NHS Trust /ID# 137973 Oxford United Kingdom OX3 7LE

    Sponsors and Collaborators

    • AbbVie
    • Gynecologic Oncology Group;Australia New Zealand Gynaecological Oncology Group

    Investigators

    • Study Director: AbbVie Inc., AbbVie

    Study Documents (Full-Text)

    More Information

    Publications

    Responsible Party:
    AbbVie
    ClinicalTrials.gov Identifier:
    NCT02470585
    Other Study ID Numbers:
    • M13-694
    • 2014-005070-11
    First Posted:
    Jun 12, 2015
    Last Update Posted:
    Jun 14, 2022
    Last Verified:
    May 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Product Manufactured in and Exported from the U.S.:
    No
    Keywords provided by AbbVie
    Veliparib
    Carboplatin
    Paclitaxel
    Overall Survival
    ABT-888
    Randomized
    Poly Adenosine Diphosphate (ADP) - Ribose Polymerase (PARP)
    Ovarian
    BRCA
    VELIA
    Additional relevant MeSH terms:
    Ovarian Neoplasms
    Paclitaxel
    Carboplatin
    Veliparib

    Study Results

    Participant Flow

    Recruitment Details This trial was conducted at 188 sites in 10 countries (Australia, Brazil, Denmark, Israel, Japan, Poland, Republic of Korea, Spain, United Kingdom, and United States). The study is currently ongoing; the data-cutoff date for the primary analysis results reported below was May 3, 2019.
    Pre-assignment Detail Participants were randomized in a 1:1:1 ratio to one of three treatment groups. Randomization was stratified according to the timing of surgery and residual disease after primary surgery, the paclitaxel schedule, stage of disease, geographic region, and germline breast cancer susceptibility gene (BRCA) status.
    Arm/Group Title Placebo + Carboplatin + Paclitaxel -> Placebo Veliparib + Carboplatin + Paclitaxel -> Placebo Veliparib + Carboplatin + Paclitaxel -> Veliparib
    Arm/Group Description Participants received placebo to veliparib orally twice a day in combination with carboplatin given at an area under the curve (AUC) of 6 milligrams per milliliter per minute (mg/mL/min) every 3 weeks, and paclitaxel 175 mg per square meter (mg/m²) of body-surface area (BSA), administered every 3 weeks, or 80 mg/m² administered weekly, for six 21-day cycles. Participants who completed chemotherapy without disease progression received matching placebo twice daily for an additional thirty 21-day cycles of maintenance therapy. Participants received 150 mg veliparib orally twice a day in combination with carboplatin given at an AUC of 6 mg/mL/min every 3 weeks and paclitaxel 175 mg/m² of BSA administered every 3 weeks, or 80 mg/m² administered weekly, for six 21-day cycles. Participants who completed chemotherapy without disease progression received matching placebo twice daily for an additional thirty 21-day cycles of maintenance therapy. Participants received 150 mg veliparib orally twice a day in combination with carboplatin given at an AUC of 6 mg/mL/min every 3 weeks and paclitaxel 175 mg/m² of BSA administered every 3 weeks, or 80 mg/m² administered weekly, for six 21-day cycles. Participants who completed chemotherapy without disease progression received single-agent veliparib at a dose of 300 mg twice daily for 2 weeks (transition period) and then 400 mg veliparib twice daily if the dose in the transition period was not associated with limiting side effects for an additional thirty 21-day cycles of maintenance therapy.
    Period Title: Overall Study
    STARTED 375 383 382
    Received Study Drug 371 376 377
    COMPLETED 268 266 257
    NOT COMPLETED 107 117 125

    Baseline Characteristics

    Arm/Group Title Placebo + Carboplatin + Paclitaxel -> Placebo Veliparib + Carboplatin + Paclitaxel -> Placebo Veliparib + Carboplatin + Paclitaxel -> Veliparib Total
    Arm/Group Description Participants received placebo to veliparib orally twice a day in combination with carboplatin given at an area under the curve [AUC] of 6 mg per milliliter per minute (mg/mL/min), every 3 weeks, and paclitaxel 175 mg per square meter (mg/m²) of body-surface area (BSA), administered every 3 weeks, or 80 mg/m² administered weekly, for six 21-day cycles. Participants who completed chemotherapy without disease progression received matching placebo twice daily for an additional thirty 21-day cycles of maintenance therapy. Participants received 150 mg veliparib orally twice a day in combination with carboplatin given at an AUC of 6 mg/mL/min every 3 weeks and paclitaxel 175 mg/m² of BSA administered every 3 weeks, or 80 mg/m² administered weekly, for six 21-day cycles. Participants who completed chemotherapy without disease progression received matching placebo twice daily for an additional thirty 21-day cycles of maintenance therapy. Participants received 150 mg veliparib orally twice a day in combination with carboplatin given at an AUC of 6 mg/mL/min every 3 weeks and paclitaxel 175 mg/m² of BSA administered every 3 weeks, or 80 mg/m² administered weekly, for six 21-day cycles. Participants who completed chemotherapy without disease progression received single-agent veliparib at a dose of 300 mg twice daily for 2 weeks (transition period) and then 400 mg veliparib twice daily if the dose in the transition period was not associated with limiting side effects for an additional thirty 21-day cycles of maintenance therapy. Total of all reporting groups
    Overall Participants 375 383 382 1140
    Age (years) [Median (Full Range) ]
    Median (Full Range) [years]
    62.0
    62.0
    62.0
    62.0
    Age, Customized (Count of Participants)
    < 65 years
    233
    62.1%
    226
    59%
    228
    59.7%
    687
    60.3%
    ≥ 65 years
    142
    37.9%
    157
    41%
    154
    40.3%
    453
    39.7%
    Sex: Female, Male (Count of Participants)
    Female
    375
    100%
    383
    100%
    382
    100%
    1140
    100%
    Male
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    Ethnicity (NIH/OMB) (Count of Participants)
    Hispanic or Latino
    28
    7.5%
    27
    7%
    26
    6.8%
    81
    7.1%
    Not Hispanic or Latino
    347
    92.5%
    356
    93%
    356
    93.2%
    1059
    92.9%
    Unknown or Not Reported
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    Race/Ethnicity, Customized (Count of Participants)
    White
    299
    79.7%
    297
    77.5%
    300
    78.5%
    896
    78.6%
    Black or African American
    10
    2.7%
    13
    3.4%
    20
    5.2%
    43
    3.8%
    Asian
    59
    15.7%
    69
    18%
    56
    14.7%
    184
    16.1%
    American Indian or Alaska Native
    1
    0.3%
    1
    0.3%
    1
    0.3%
    3
    0.3%
    Native Hawaiian or other Pacific Islander
    1
    0.3%
    0
    0%
    2
    0.5%
    3
    0.3%
    Multi-race
    3
    0.8%
    0
    0%
    0
    0%
    3
    0.3%
    Missing
    2
    0.5%
    3
    0.8%
    3
    0.8%
    8
    0.7%
    Geographic Region (Count of Participants)
    North America
    266
    70.9%
    261
    68.1%
    267
    69.9%
    794
    69.6%
    Japan
    23
    6.1%
    30
    7.8%
    25
    6.5%
    78
    6.8%
    Rest of World
    86
    22.9%
    92
    24%
    90
    23.6%
    268
    23.5%
    BRCA-Deficient Status (Count of Participants)
    Germline or tissue BRCA1/2 mutation
    92
    24.5%
    98
    25.6%
    108
    28.3%
    298
    26.1%
    Germline or tissue BRCA1/2 wildtype
    254
    67.7%
    243
    63.4%
    245
    64.1%
    742
    65.1%
    Missing
    29
    7.7%
    42
    11%
    29
    7.6%
    100
    8.8%
    Homologous Recombination Deficiency (HRD) Status (Count of Participants)
    HRD
    207
    55.2%
    206
    53.8%
    214
    56%
    627
    55%
    Non-HRD
    124
    33.1%
    123
    32.1%
    125
    32.7%
    372
    32.6%
    Missing
    44
    11.7%
    54
    14.1%
    43
    11.3%
    141
    12.4%
    Stage of Disease (Count of Participants)
    Stage III
    292
    77.9%
    288
    75.2%
    295
    77.2%
    875
    76.8%
    Stage IV
    82
    21.9%
    94
    24.5%
    87
    22.8%
    263
    23.1%
    Missing
    1
    0.3%
    1
    0.3%
    0
    0%
    2
    0.2%
    Type of Surgery Received (Count of Participants)
    Primary
    250
    66.7%
    253
    66.1%
    261
    68.3%
    764
    67%
    Interval
    107
    28.5%
    114
    29.8%
    99
    25.9%
    320
    28.1%
    No surgery received
    18
    4.8%
    16
    4.2%
    22
    5.8%
    56
    4.9%
    Residual Disease After Primary Surgery (Count of Participants)
    No residual disease
    116
    30.9%
    118
    30.8%
    124
    32.5%
    358
    31.4%
    Microscopic residual disease only
    58
    15.5%
    46
    12%
    54
    14.1%
    158
    13.9%
    Any macroscopic residual disease
    76
    20.3%
    89
    23.2%
    83
    21.7%
    248
    21.8%
    Residual Disease After Interval Surgery (Count of Participants)
    No residual disease
    50
    13.3%
    46
    12%
    45
    11.8%
    141
    12.4%
    Microscopic residual disease only
    22
    5.9%
    30
    7.8%
    24
    6.3%
    76
    6.7%
    Any macroscopic residual disease
    31
    8.3%
    34
    8.9%
    27
    7.1%
    92
    8.1%
    Missing
    4
    1.1%
    4
    1%
    3
    0.8%
    11
    1%
    Paclitaxel Dosing Regimen (Count of Participants)
    Weekly
    193
    51.5%
    203
    53%
    190
    49.7%
    586
    51.4%
    Every 3 weeks
    179
    47.7%
    178
    46.5%
    189
    49.5%
    546
    47.9%
    Missing
    3
    0.8%
    2
    0.5%
    3
    0.8%
    8
    0.7%
    Germline BRCA Status (Count of Participants)
    Germline BRCA1/2 mutation
    63
    16.8%
    71
    18.5%
    80
    20.9%
    214
    18.8%
    Germline BRCA1/2 wildtype
    305
    81.3%
    305
    79.6%
    298
    78%
    908
    79.6%
    Missing
    7
    1.9%
    7
    1.8%
    4
    1%
    18
    1.6%

    Outcome Measures

    1. Primary Outcome
    Title Progression-Free Survival (PFS) in the BRCA-deficient Population
    Description PFS was defined as the time from the date that the participant was randomized to the date the participant experienced an event of disease progression, according to Response Evaluation Criteria In Solid Tumors (RECIST) criteria version 1.1 (as determined by the investigator) or to the date of death if disease progression was not reached. If the participant did not have an event of disease progression or death prior to the analysis cut-off date, the participant's data were censored at the date of their last evaluable disease assessment. PFS was estimated using the Kaplan-Meier method. The analysis of PFS occurred when the protocol-specified number of PFS events was reached. Progressive Disease (PD): At least a 20% increase in the size of target lesions, compared with the smallest size recorded since the treatment started, and an absolute increase of ≥ 5 mm, or unequivocal progression of existing non-target lesions or the appearance of new lesions.
    Time Frame From randomization until the primary analysis data cut-off date of 03 May 2019, the median duration of follow-up was 28 months.

    Outcome Measure Data

    Analysis Population Description
    Analyses were performed in 3 sequentially inclusive populations. The first analysis was conducted using the BRCA-mutation cohort which included participants with either a gBRCA and/or tBRCA deleterious or suspected deleterious mutation in BRCA1 or BRCA2.
    Arm/Group Title Placebo + Carboplatin + Paclitaxel -> Placebo Veliparib + Carboplatin + Paclitaxel -> Placebo Veliparib + Carboplatin + Paclitaxel -> Veliparib
    Arm/Group Description Participants received placebo to veliparib orally twice a day in combination with carboplatin given at an area under the curve [AUC] of 6 mg per milliliter per minute (mg/mL/min), every 3 weeks, and paclitaxel 175 mg per square meter (mg/m²) of body-surface area (BSA), administered every 3 weeks, or 80 mg/m² administered weekly, for six 21-day cycles. Participants who completed chemotherapy without disease progression received matching placebo twice daily for an additional thirty 21-day cycles of maintenance therapy. Participants received 150 mg veliparib orally twice a day in combination with carboplatin given at an AUC of 6 mg/mL/min every 3 weeks and paclitaxel 175 mg/m² of BSA administered every 3 weeks, or 80 mg/m² administered weekly, for six 21-day cycles. Participants who completed chemotherapy without disease progression received matching placebo twice daily for an additional thirty 21-day cycles of maintenance therapy. Participants received 150 mg veliparib orally twice a day in combination with carboplatin given at an AUC of 6 mg/mL/min every 3 weeks and paclitaxel 175 mg/m² of BSA administered every 3 weeks, or 80 mg/m² administered weekly, for six 21-day cycles. Participants who completed chemotherapy without disease progression received single-agent veliparib at a dose of 300 mg twice daily for 2 weeks (transition period) and then 400 mg veliparib twice daily if the dose in the transition period was not associated with limiting side effects for an additional thirty 21-day cycles of maintenance therapy.
    Measure Participants 92 98 108
    Median (95% Confidence Interval) [months]
    22.0
    21.1
    34.7
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Placebo + Carboplatin + Paclitaxel -> Placebo, Veliparib + Carboplatin + Paclitaxel -> Veliparib
    Comments The primary efficacy analyses compared investigator-assessed PFS in the Veliparib + Carboplatin + Paclitaxel -> Veliparib group vs. the Placebo + Carboplatin + Paclitaxel -> Placebo group.
    Type of Statistical Test Superiority
    Comments Multiplicity considerations included 3 treatment arms, (2 pairwise comparisons), 3 sequentially inclusive populations (BRCA-mutation population, HRD population, and ITT population), and multiple endpoints. A fixed-sequence testing procedure was used to control the Type I error rate at 0.05 from the primary efficacy endpoints sequentially through the secondary efficacy endpoints.
    Statistical Test of Hypothesis p-Value <0.001
    Comments A 2-sided p-value of ≤ 0.05 was considered statistically significant in the following hierarchical testing sequence: PFS was to be compared first in the BRCA-mutation cohort, then in the HRD cohort, and then in the ITT population.
    Method Log Rank
    Comments Stratified according to residual disease status and disease stage.
    Method of Estimation Estimation Parameter Hazard Ratio (HR)
    Estimated Value 0.435
    Confidence Interval (2-Sided) 95%
    0.277 to 0.683
    Parameter Dispersion Type:
    Value:
    Estimation Comments Cox proportional hazards model stratified according to the same factors as those used in the log-rank test above.
    2. Primary Outcome
    Title Progression-Free Survival (PFS) in the Homologous Recombination Deficiency Cohort
    Description PFS was defined as the time from the date that the participant was randomized to the date the participant experienced an event of disease progression, according to Response Evaluation Criteria In Solid Tumors (RECIST) criteria version 1.1 (as determined by the investigator) or to the date of death if disease progression was not reached. If the participant did not have an event of disease progression or death, the participant's data were censored at the date of their last evaluable disease assessment. PFS was estimated using the Kaplan-Meier method. The primary analysis of PFS occurred when the protocol-specified number of PFS events was reached and was performed in 3 sequentially inclusive populations. Progressive Disease (PD): At least a 20% increase in the size of target lesions, compared with the smallest size recorded since the treatment started, and an absolute increase of ≥ 5 mm, or unequivocal progression of existing non-target lesions or the appearance of new lesions. .
    Time Frame From randomization until the primary analysis data cut-off date of 03 May 2019, the median duration of follow-up was 28 months.

    Outcome Measure Data

    Analysis Population Description
    Analyses were performed in 3 sequentially inclusive populations. The second analysis was conducted using the HRD cohort which included participants in the BRCA-mutation cohort and those determined to have HRD tumors.
    Arm/Group Title Placebo + Carboplatin + Paclitaxel -> Placebo Veliparib + Carboplatin + Paclitaxel -> Placebo Veliparib + Carboplatin + Paclitaxel -> Veliparib
    Arm/Group Description Participants received placebo to veliparib orally twice a day in combination with carboplatin given at an area under the curve [AUC] of 6 mg per milliliter per minute (mg/mL/min), every 3 weeks, and paclitaxel 175 mg per square meter (mg/m²) of body-surface area (BSA), administered every 3 weeks, or 80 mg/m² administered weekly, for six 21-day cycles. Participants who completed chemotherapy without disease progression received matching placebo twice daily for an additional thirty 21-day cycles of maintenance therapy. Participants received 150 mg veliparib orally twice a day in combination with carboplatin given at an AUC of 6 mg/mL/min every 3 weeks and paclitaxel 175 mg/m² of BSA administered every 3 weeks, or 80 mg/m² administered weekly, for six 21-day cycles. Participants who completed chemotherapy without disease progression received matching placebo twice daily for an additional thirty 21-day cycles of maintenance therapy. Participants received 150 mg veliparib orally twice a day in combination with carboplatin given at an AUC of 6 mg/mL/min every 3 weeks and paclitaxel 175 mg/m² of BSA administered every 3 weeks, or 80 mg/m² administered weekly, for six 21-day cycles. Participants who completed chemotherapy without disease progression received single-agent veliparib at a dose of 300 mg twice daily for 2 weeks (transition period) and then 400 mg veliparib twice daily if the dose in the transition period was not associated with limiting side effects for an additional thirty 21-day cycles of maintenance therapy.
    Measure Participants 207 206 214
    Median (95% Confidence Interval) [months]
    20.5
    18.1
    31.9
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Placebo + Carboplatin + Paclitaxel -> Placebo, Veliparib + Carboplatin + Paclitaxel -> Veliparib
    Comments
    Type of Statistical Test Superiority
    Comments Multiplicity considerations included 3 treatment arms, (2 pairwise comparisons), 3 sequentially inclusive populations (BRCA-mutation population, HRD population, and ITT population), and multiple endpoints. A fixed-sequence testing procedure was used to control the Type I error rate at 0.05 from the primary efficacy endpoints sequentially through the secondary efficacy endpoints.
    Statistical Test of Hypothesis p-Value <0.001
    Comments A 2-sided p-value of ≤ 0.05 was considered statistically significant in the following hierarchical testing sequence: PFS was to be compared first in the BRCA-mutation cohort, then in the HRD cohort, and then in the ITT population.
    Method Log Rank
    Comments Stratified according to residual disease status and disease stage.
    Method of Estimation Estimation Parameter Hazard Ratio (HR)
    Estimated Value 0.572
    Confidence Interval (2-Sided) 95%
    0.433 to 0.756
    Parameter Dispersion Type:
    Value:
    Estimation Comments Cox proportional hazards model stratified according to the same factors as those used in the log-rank test above.
    3. Primary Outcome
    Title Progression-Free Survival (PFS) in the Intention-to-treat Population
    Description PFS was defined as the time from the date that the participant was randomized to the date the participant experienced an event of disease progression, according to Response Evaluation Criteria In Solid Tumors (RECIST) criteria version 1.1 (as determined by the investigator) or to the date of death (all causes of mortality) if disease progression was not reached. If the participant did not have an event of disease progression according to RECIST criteria (as or death, the participant's data were censored at the date of their last evaluable disease assessment. PFS was estimated using the Kaplan-Meier method. Progressive Disease (PD): At least a 20% increase in the size of target lesions, compared with the smallest size recorded since the treatment started, and an absolute increase of ≥ 5 mm, or unequivocal progression of existing non-target lesions or the appearance of new lesions. The primary analysis of PFS occurred when the protocol-specified number of PFS events was reached.
    Time Frame From randomization until the primary analysis data cut-off date of 03 May 2019, the median duration of follow-up was 28 months.

    Outcome Measure Data

    Analysis Population Description
    Analyses were performed in 3 sequentially inclusive populations. The third analysis was conducted using the intention-to-treat (ITT) population (all randomized participants).
    Arm/Group Title Placebo + Carboplatin + Paclitaxel -> Placebo Veliparib + Carboplatin + Paclitaxel -> Placebo Veliparib + Carboplatin + Paclitaxel -> Veliparib
    Arm/Group Description Participants received placebo to veliparib orally twice a day in combination with carboplatin given at an area under the curve [AUC] of 6 mg per milliliter per minute (mg/mL/min), every 3 weeks, and paclitaxel 175 mg per square meter (mg/m²) of body-surface area (BSA), administered every 3 weeks, or 80 mg/m² administered weekly, for six 21-day cycles. Participants who completed chemotherapy without disease progression received matching placebo twice daily for an additional thirty 21-day cycles of maintenance therapy. Participants received 150 mg veliparib orally twice a day in combination with carboplatin given at an AUC of 6 mg/mL/min every 3 weeks and paclitaxel 175 mg/m² of BSA administered every 3 weeks, or 80 mg/m² administered weekly, for six 21-day cycles. Participants who completed chemotherapy without disease progression received matching placebo twice daily for an additional thirty 21-day cycles of maintenance therapy. Participants received 150 mg veliparib orally twice a day in combination with carboplatin given at an AUC of 6 mg/mL/min every 3 weeks and paclitaxel 175 mg/m² of BSA administered every 3 weeks, or 80 mg/m² administered weekly, for six 21-day cycles. Participants who completed chemotherapy without disease progression received single-agent veliparib at a dose of 300 mg twice daily for 2 weeks (transition period) and then 400 mg veliparib twice daily if the dose in the transition period was not associated with limiting side effects for an additional thirty 21-day cycles of maintenance therapy.
    Measure Participants 375 383 382
    Median (95% Confidence Interval) [months]
    17.3
    15.2
    23.5
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Placebo + Carboplatin + Paclitaxel -> Placebo, Veliparib + Carboplatin + Paclitaxel -> Veliparib
    Comments
    Type of Statistical Test Superiority
    Comments Multiplicity considerations included 3 treatment arms, (2 pairwise comparisons), 3 sequentially inclusive populations (BRCA-mutation population, HRD population, and ITT population), and multiple endpoints. A fixed-sequence testing procedure was used to control the Type I error rate at 0.05 from the primary efficacy endpoints sequentially through the secondary efficacy endpoints.
    Statistical Test of Hypothesis p-Value <0.001
    Comments A 2-sided p-value of ≤ 0.05 was considered statistically significant in the following hierarchical testing sequence: PFS was to be compared first in the BRCA-mutation cohort, then in the HRD cohort, and then in the ITT population.
    Method Log Rank
    Comments Stratified according to residual disease status and disease stage, choice of the paclitaxel regimen, and BRCA-mutation status
    Method of Estimation Estimation Parameter Hazard Ratio (HR)
    Estimated Value 0.683
    Confidence Interval (2-Sided) 95%
    0.562 to 0.831
    Parameter Dispersion Type:
    Value:
    Estimation Comments Cox proportional hazards model stratified according to the same factors as those used in the log-rank test above.
    4. Secondary Outcome
    Title Overall Survival (OS)
    Description OS is defined as the time from the day the participant was randomized to the date of death. All events of death will be included, regardless of whether the event occurs while the participant is still taking study drug, or after discontinuation of study drug. If a participant has not died, then the data will be censored at the date the participant is last known to be alive. The final analysis of OS will occur when the pre-specified number of events has occurred in the ITT and HRD populations.
    Time Frame Approximately 8 years from randomization.

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title
    Arm/Group Description
    5. Secondary Outcome
    Title Change From Baseline in Disease Related Symptom (DRS) Score in the BRCA-mutation Population
    Description The Disease Related Symptom score is a subset of the National Comprehensive Cancer Network Functional Assessment of Cancer Therapy Ovarian Symptom Index-18 (NFOSI-18), which evaluates nine symptoms related to ovarian cancer. The NFOSI-18 DRS score ranges from 0 to 36, with higher scores indicating a lower burden of symptoms and a score of 0 being severely symptomatic. A 3-point difference was defined as clinically meaningful. A positive change from Baseline indicates improvement. Change from Baseline was calculated using a used a mixed-model for repeated measures (MMRM) with treatment, stratification factors of residual disease and stage of disease, time point and treatment-by-time point interaction as fixed effect factors, and Baseline DRS score as a covariate. DRS was not included in the fixed-sequence testing procedure.
    Time Frame Baseline and Day 1 of Cycles 3, 5, 7, 9, 11, 13, 15, 17, 19, 21, 23, 25, 27, 29, 31, 33, and 35

    Outcome Measure Data

    Analysis Population Description
    BRCA-mutation population, participants with available data at each time point.
    Arm/Group Title Placebo + Carboplatin + Paclitaxel -> Placebo Veliparib + Carboplatin + Paclitaxel -> Placebo Veliparib + Carboplatin + Paclitaxel -> Veliparib
    Arm/Group Description Participants received placebo to veliparib orally twice a day in combination with carboplatin given at an area under the curve [AUC] of 6 mg per milliliter per minute (mg/mL/min), every 3 weeks, and paclitaxel 175 mg per square meter (mg/m²) of body-surface area (BSA), administered every 3 weeks, or 80 mg/m² administered weekly, for six 21-day cycles. Participants who completed chemotherapy without disease progression received matching placebo twice daily for an additional thirty 21-day cycles of maintenance therapy. Participants received 150 mg veliparib orally twice a day in combination with carboplatin given at an AUC of 6 mg/mL/min every 3 weeks and paclitaxel 175 mg/m² of BSA administered every 3 weeks, or 80 mg/m² administered weekly, for six 21-day cycles. Participants who completed chemotherapy without disease progression received matching placebo twice daily for an additional thirty 21-day cycles of maintenance therapy. Participants received 150 mg veliparib orally twice a day in combination with carboplatin given at an AUC of 6 mg/mL/min every 3 weeks and paclitaxel 175 mg/m² of BSA administered every 3 weeks, or 80 mg/m² administered weekly, for six 21-day cycles. Participants who completed chemotherapy without disease progression received single-agent veliparib at a dose of 300 mg twice daily for 2 weeks (transition period) and then 400 mg veliparib twice daily if the dose in the transition period was not associated with limiting side effects for an additional thirty 21-day cycles of maintenance therapy.
    Measure Participants 92 98 108
    Cycle 3
    1.8
    (0.52)
    0.5
    (0.53)
    0.9
    (0.51)
    Cycle 5
    1.7
    (0.57)
    0.7
    (0.58)
    0.4
    (0.56)
    Cycle 7
    2.6
    (0.54)
    1.8
    (0.54)
    1.8
    (0.53)
    Cycle 9
    3.3
    (0.60)
    3.3
    (0.60)
    2.4
    (0.59)
    Cycle 11
    3.2
    (0.56)
    3.6
    (0.55)
    2.9
    (0.54)
    Cycle 13
    3.6
    (0.57)
    3.8
    (0.57)
    3.0
    (0.57)
    Cycle 15
    4.3
    (0.53)
    4.0
    (0.54)
    3.4
    (0.52)
    Cycle 17
    3.8
    (0.56)
    4.0
    (0.57)
    3.2
    (0.55)
    Cycle 19
    4.0
    (0.62)
    4.0
    (0.63)
    2.7
    (0.59)
    Cycle 21
    4.6
    (0.59)
    3.9
    (0.59)
    3.2
    (0.55)
    Cycle 23
    4.3
    (0.55)
    4.0
    (0.55)
    2.8
    (0.52)
    Cycle 25
    4.1
    (0.58)
    5.0
    (0.59)
    3.5
    (0.55)
    Cycle 27
    4.6
    (0.55)
    4.8
    (0.56)
    3.0
    (0.52)
    Cycle 29
    4.0
    (0.66)
    5.3
    (0.66)
    2.8
    (0.59)
    Cycle 31
    5.0
    (0.56)
    4.8
    (0.57)
    2.9
    (0.51)
    Cycle 33
    4.1
    (0.67)
    5.0
    (0.66)
    3.9
    (0.59)
    Cycle 35
    4.6
    (0.64)
    4.6
    (0.63)
    3.3
    (0.58)
    6. Secondary Outcome
    Title Change From Baseline in Disease Related Symptom (DRS) Score in the HRD Population
    Description The Disease Related Symptom score is a subset of the National Comprehensive Cancer Network Functional Assessment of Cancer Therapy Ovarian Symptom Index-18 (NFOSI-18), which evaluates nine symptoms related to ovarian cancer. The NFOSI-18 DRS score ranges from 0 to 36, with higher scores indicating a lower burden of symptoms and a score of 0 being severely symptomatic. A 3-point difference was defined as clinically meaningful. A positive change from Baseline indicates improvement. Change from Baseline was calculated using a used a mixed-model for repeated measures (MMRM) with treatment, stratification factors of residual disease and stage of disease, time point and treatment-by-time point interaction as fixed effect factors, and Baseline DRS score as a covariate. DRS was not included in the fixed-sequence testing procedure.
    Time Frame Baseline and Day 1 of Cycles 3, 5, 7, 9, 11, 13, 15, 17, 19, 21, 23, 25, 27, 29, 31, 33, and 35

    Outcome Measure Data

    Analysis Population Description
    HRD population, participants with available data at each time point.
    Arm/Group Title Placebo + Carboplatin + Paclitaxel -> Placebo Veliparib + Carboplatin + Paclitaxel -> Placebo Veliparib + Carboplatin + Paclitaxel -> Veliparib
    Arm/Group Description Participants received placebo to veliparib orally twice a day in combination with carboplatin given at an area under the curve [AUC] of 6 mg per milliliter per minute (mg/mL/min), every 3 weeks, and paclitaxel 175 mg per square meter (mg/m²) of body-surface area (BSA), administered every 3 weeks, or 80 mg/m² administered weekly, for six 21-day cycles. Participants who completed chemotherapy without disease progression received matching placebo twice daily for an additional thirty 21-day cycles of maintenance therapy. Participants received 150 mg veliparib orally twice a day in combination with carboplatin given at an AUC of 6 mg/mL/min every 3 weeks and paclitaxel 175 mg/m² of BSA administered every 3 weeks, or 80 mg/m² administered weekly, for six 21-day cycles. Participants who completed chemotherapy without disease progression received matching placebo twice daily for an additional thirty 21-day cycles of maintenance therapy. Participants received 150 mg veliparib orally twice a day in combination with carboplatin given at an AUC of 6 mg/mL/min every 3 weeks and paclitaxel 175 mg/m² of BSA administered every 3 weeks, or 80 mg/m² administered weekly, for six 21-day cycles. Participants who completed chemotherapy without disease progression received single-agent veliparib at a dose of 300 mg twice daily for 2 weeks (transition period) and then 400 mg veliparib twice daily if the dose in the transition period was not associated with limiting side effects for an additional thirty 21-day cycles of maintenance therapy.
    Measure Participants 207 206 214
    Cycle 3
    1.5
    (0.35)
    0.5
    (0.36)
    0.9
    (0.35)
    Cycle 5
    1.7
    (0.37)
    1.1
    (0.37)
    0.8
    (0.37)
    Cycle 7
    2.4
    (0.35)
    1.8
    (0.36)
    2.2
    (0.35)
    Cycle 9
    3.3
    (0.37)
    3.6
    (0.38)
    2.3
    (0.38)
    Cycle 11
    3.5
    (0.36)
    3.5
    (0.36)
    2.7
    (0.36)
    Cycle 13
    3.6
    (0.37)
    3.8
    (0.38)
    2.7
    (0.39)
    Cycle 15
    4.2
    (0.35)
    3.9
    (0.36)
    3.3
    (0.37)
    Cycle 17
    3.9
    (0.39)
    3.4
    (0.41)
    3.0
    (0.40)
    Cycle 19
    4.2
    (0.40)
    3.7
    (0.42)
    2.7
    (0.41)
    Cycle 21
    4.6
    (0.40)
    3.6
    (0.41)
    3.0
    (0.40)
    Cycle 23
    4.1
    (0.38)
    3.6
    (0.39)
    3.2
    (0.38)
    Cycle 25
    4.1
    (0.40)
    4.4
    (0.41)
    3.5
    (0.40)
    Cycle 27
    4.4
    (0.39)
    4.4
    (0.40)
    3.0
    (0.38)
    Cycle 29
    4.2
    (0.43)
    4.7
    (0.44)
    3.2
    (0.41)
    Cycle 31
    4.0
    (0.41)
    4.3
    (0.42)
    3.3
    (0.40)
    Cycle 33
    4.3
    (0.45)
    4.7
    (0.45)
    3.9
    (0.43)
    Cycle 35
    4.0
    (0.46)
    4.6
    (0.47)
    3.3
    (0.45)
    7. Secondary Outcome
    Title Change From Baseline in Disease Related Symptom (DRS) Score in the ITT Population
    Description The Disease Related Symptom score is a subset of the National Comprehensive Cancer Network Functional Assessment of Cancer Therapy Ovarian Symptom Index-18 (NFOSI-18), which evaluates nine symptoms related to ovarian cancer. The NFOSI-18 DRS score ranges from 0 to 36, with higher scores indicating a lower burden of symptoms and a score of 0 being severely symptomatic. A 3-point difference was defined as clinically meaningful. A positive change from Baseline indicates improvement. Change from Baseline was calculated using a used a mixed-model for repeated measures (MMRM) with treatment, stratification factors of residual disease, stage of disease, choice of paclitaxel dosing regimen and BRCA-deficient status, time point and treatment-by-time point interaction as fixed effect factors, and Baseline DRS score as a covariate. DRS was not included in the fixed-sequence testing procedure.
    Time Frame Baseline and Day 1 of Cycles 3, 5, 7, 9, 11, 13, 15, 17, 19, 21, 23, 25, 27, 29, 31, 33, and 35

    Outcome Measure Data

    Analysis Population Description
    ITT population, participants with available data at each time point.
    Arm/Group Title Placebo + Carboplatin + Paclitaxel -> Placebo Veliparib + Carboplatin + Paclitaxel -> Placebo Veliparib + Carboplatin + Paclitaxel -> Veliparib
    Arm/Group Description Participants received placebo to veliparib orally twice a day in combination with carboplatin given at an area under the curve [AUC] of 6 mg per milliliter per minute (mg/mL/min), every 3 weeks, and paclitaxel 175 mg per square meter (mg/m²) of body-surface area (BSA), administered every 3 weeks, or 80 mg/m² administered weekly, for six 21-day cycles. Participants who completed chemotherapy without disease progression received matching placebo twice daily for an additional thirty 21-day cycles of maintenance therapy. Participants received 150 mg veliparib orally twice a day in combination with carboplatin given at an AUC of 6 mg/mL/min every 3 weeks and paclitaxel 175 mg/m² of BSA administered every 3 weeks, or 80 mg/m² administered weekly, for six 21-day cycles. Participants who completed chemotherapy without disease progression received matching placebo twice daily for an additional thirty 21-day cycles of maintenance therapy. Participants received 150 mg veliparib orally twice a day in combination with carboplatin given at an AUC of 6 mg/mL/min every 3 weeks and paclitaxel 175 mg/m² of BSA administered every 3 weeks, or 80 mg/m² administered weekly, for six 21-day cycles. Participants who completed chemotherapy without disease progression received single-agent veliparib at a dose of 300 mg twice daily for 2 weeks (transition period) and then 400 mg veliparib twice daily if the dose in the transition period was not associated with limiting side effects for an additional thirty 21-day cycles of maintenance therapy.
    Measure Participants 375 383 382
    Cycle 3
    1.5
    (0.28)
    0.4
    (0.28)
    1.0
    (0.28)
    Cycle 5
    1.6
    (0.29)
    0.9
    (0.29)
    0.8
    (0.29)
    Cycle 7
    2.3
    (0.29)
    1.8
    (0.29)
    2.1
    (0.29)
    Cycle 9
    3.3
    (0.29)
    3.8
    (0.29)
    2.4
    (0.29)
    Cycle 11
    3.5
    (0.29)
    4.0
    (0.28)
    3.0
    (0.29)
    Cycle 13
    3.8
    (0.30)
    4.0
    (0.30)
    3.2
    (0.30)
    Cycle 15
    4.2
    (0.30)
    3.8
    (0.30)
    3.3
    (0.30)
    Cycle 17
    4.1
    (0.32)
    3.7
    (0.32)
    3.4
    (0.32)
    Cycle 19
    4.4
    (0.32)
    4.0
    (0.32)
    3.1
    (0.32)
    Cycle 21
    4.3
    (0.34)
    3.6
    (0.34)
    3.3
    (0.33)
    Cycle 23
    4.0
    (0.33)
    3.9
    (0.33)
    3.4
    (0.32)
    Cycle 25
    4.0
    (0.34)
    4.1
    (0.35)
    3.5
    (0.33)
    Cycle 27
    4.4
    (0.33)
    4.2
    (0.33)
    3.5
    (0.32)
    Cycle 29
    4.3
    (0.35)
    4.4
    (0.35)
    3.4
    (0.33)
    Cycle 31
    4.0
    (0.36)
    4.1
    (0.37)
    3.3
    (0.35)
    Cycle 33
    4.2
    (0.38)
    4.5
    (0.38)
    3.8
    (0.36)
    Cycle 35
    4.4
    (0.38)
    4.2
    (0.38)
    3.8
    (0.37)

    Adverse Events

    Time Frame From the first dose of study drug and no more than 30 days after the last dose of any study treatment up to the data cut-off date of 03 May 2019; median duration of treatment with veliparib/placebo was 369 days (range: 1 to 840 days).
    Adverse Event Reporting Description
    Arm/Group Title Placebo + Carboplatin + Paclitaxel -> Placebo Veliparib + Carboplatin + Paclitaxel -> Placebo Veliparib + Carboplatin + Paclitaxel -> Veliparib
    Arm/Group Description Participants received placebo to veliparib orally twice a day in combination with carboplatin given at an area under the curve [AUC] of 6 mg per milliliter per minute (mg/mL/min), every 3 weeks, and paclitaxel 175 mg per square meter (mg/m²) of body-surface area (BSA), administered every 3 weeks, or 80 mg/m² administered weekly, for six 21-day cycles. Participants who completed chemotherapy without disease progression received matching placebo twice daily for an additional thirty 21-day cycles of maintenance therapy. Participants received 150 mg veliparib orally twice a day in combination with carboplatin given at an AUC of 6 mg/mL/min every 3 weeks and paclitaxel 175 mg/m² of BSA administered every 3 weeks, or 80 mg/m² administered weekly, for six 21-day cycles. Participants who completed chemotherapy without disease progression received matching placebo twice daily for an additional thirty 21-day cycles of maintenance therapy. Participants received 150 mg veliparib orally twice a day in combination with carboplatin given at an AUC of 6 mg/mL/min every 3 weeks and paclitaxel 175 mg/m² of BSA administered every 3 weeks, or 80 mg/m² administered weekly, for six 21-day cycles. Participants who completed chemotherapy without disease progression received single-agent veliparib at a dose of 300 mg twice daily for 2 weeks (transition period) and then 400 mg veliparib twice daily if the dose in the transition period was not associated with limiting side effects for an additional thirty 21-day cycles of maintenance therapy.
    All Cause Mortality
    Placebo + Carboplatin + Paclitaxel -> Placebo Veliparib + Carboplatin + Paclitaxel -> Placebo Veliparib + Carboplatin + Paclitaxel -> Veliparib
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 82/371 (22.1%) 88/376 (23.4%) 88/377 (23.3%)
    Serious Adverse Events
    Placebo + Carboplatin + Paclitaxel -> Placebo Veliparib + Carboplatin + Paclitaxel -> Placebo Veliparib + Carboplatin + Paclitaxel -> Veliparib
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 141/371 (38%) 129/376 (34.3%) 141/377 (37.4%)
    Blood and lymphatic system disorders
    ANAEMIA 4/371 (1.1%) 4 13/376 (3.5%) 14 14/377 (3.7%) 18
    FEBRILE NEUTROPENIA 9/371 (2.4%) 10 19/376 (5.1%) 20 15/377 (4%) 17
    LEUKOPENIA 0/371 (0%) 0 1/376 (0.3%) 1 0/377 (0%) 0
    NEUTROPENIA 6/371 (1.6%) 9 16/376 (4.3%) 22 12/377 (3.2%) 16
    THROMBOCYTOPENIA 3/371 (0.8%) 3 9/376 (2.4%) 12 10/377 (2.7%) 20
    Cardiac disorders
    ACUTE CORONARY SYNDROME 1/371 (0.3%) 1 0/376 (0%) 0 0/377 (0%) 0
    ATRIAL FIBRILLATION 3/371 (0.8%) 3 1/376 (0.3%) 2 1/377 (0.3%) 1
    MYOCARDIAL INFARCTION 1/371 (0.3%) 1 0/376 (0%) 0 1/377 (0.3%) 1
    PALPITATIONS 0/371 (0%) 0 2/376 (0.5%) 2 0/377 (0%) 0
    STRESS CARDIOMYOPATHY 1/371 (0.3%) 1 0/376 (0%) 0 0/377 (0%) 0
    SUPRAVENTRICULAR TACHYCARDIA 0/371 (0%) 0 1/376 (0.3%) 1 0/377 (0%) 0
    TACHYCARDIA 0/371 (0%) 0 0/376 (0%) 0 1/377 (0.3%) 1
    VENTRICULAR EXTRASYSTOLES 1/371 (0.3%) 1 0/376 (0%) 0 0/377 (0%) 0
    Endocrine disorders
    ADRENAL INSUFFICIENCY 0/371 (0%) 0 0/376 (0%) 0 1/377 (0.3%) 1
    HYPERTHYROIDISM 0/371 (0%) 0 1/376 (0.3%) 1 0/377 (0%) 0
    Eye disorders
    VISION BLURRED 1/371 (0.3%) 1 0/376 (0%) 0 0/377 (0%) 0
    Gastrointestinal disorders
    ABDOMINAL ADHESIONS 0/371 (0%) 0 1/376 (0.3%) 1 0/377 (0%) 0
    ABDOMINAL HERNIA 1/371 (0.3%) 1 1/376 (0.3%) 1 0/377 (0%) 0
    ABDOMINAL INCARCERATED HERNIA 1/371 (0.3%) 1 0/376 (0%) 0 0/377 (0%) 0
    ABDOMINAL PAIN 5/371 (1.3%) 5 9/376 (2.4%) 10 9/377 (2.4%) 10
    ABDOMINAL PAIN UPPER 0/371 (0%) 0 1/376 (0.3%) 1 0/377 (0%) 0
    ASCITES 7/371 (1.9%) 9 2/376 (0.5%) 2 2/377 (0.5%) 2
    COLITIS 1/371 (0.3%) 2 2/376 (0.5%) 2 1/377 (0.3%) 1
    COLITIS ULCERATIVE 0/371 (0%) 0 1/376 (0.3%) 1 0/377 (0%) 0
    CONSTIPATION 3/371 (0.8%) 3 5/376 (1.3%) 5 2/377 (0.5%) 2
    DIARRHOEA 3/371 (0.8%) 3 4/376 (1.1%) 5 2/377 (0.5%) 2
    DIVERTICULAR PERFORATION 1/371 (0.3%) 1 0/376 (0%) 0 0/377 (0%) 0
    ENTEROCOLITIS 1/371 (0.3%) 1 1/376 (0.3%) 1 0/377 (0%) 0
    EPIPLOIC APPENDAGITIS 1/371 (0.3%) 1 0/376 (0%) 0 0/377 (0%) 0
    GASTRIC ULCER 0/371 (0%) 0 0/376 (0%) 0 1/377 (0.3%) 1
    GASTRIC VOLVULUS 0/371 (0%) 0 1/376 (0.3%) 1 0/377 (0%) 0
    HAEMATEMESIS 0/371 (0%) 0 1/376 (0.3%) 1 0/377 (0%) 0
    HIATUS HERNIA 0/371 (0%) 0 1/376 (0.3%) 1 0/377 (0%) 0
    ILEAL PERFORATION 0/371 (0%) 0 0/376 (0%) 0 1/377 (0.3%) 1
    ILEUS 2/371 (0.5%) 2 7/376 (1.9%) 7 3/377 (0.8%) 4
    INTESTINAL OBSTRUCTION 2/371 (0.5%) 4 1/376 (0.3%) 1 6/377 (1.6%) 7
    INTESTINAL PERFORATION 0/371 (0%) 0 1/376 (0.3%) 1 0/377 (0%) 0
    INTESTINAL PSEUDO-OBSTRUCTION 0/371 (0%) 0 1/376 (0.3%) 1 0/377 (0%) 0
    INTRA-ABDOMINAL FLUID COLLECTION 1/371 (0.3%) 1 0/376 (0%) 0 0/377 (0%) 0
    LARGE INTESTINAL OBSTRUCTION 1/371 (0.3%) 1 2/376 (0.5%) 3 1/377 (0.3%) 1
    LARGE INTESTINE PERFORATION 2/371 (0.5%) 2 0/376 (0%) 0 0/377 (0%) 0
    MECHANICAL ILEUS 1/371 (0.3%) 1 0/376 (0%) 0 0/377 (0%) 0
    NAUSEA 4/371 (1.1%) 5 11/376 (2.9%) 11 13/377 (3.4%) 16
    OESOPHAGITIS ULCERATIVE 0/371 (0%) 0 1/376 (0.3%) 1 0/377 (0%) 0
    PANCREATITIS 0/371 (0%) 0 0/376 (0%) 0 1/377 (0.3%) 1
    PANCREATITIS ACUTE 0/371 (0%) 0 0/376 (0%) 0 1/377 (0.3%) 1
    PERITONEAL HAEMORRHAGE 1/371 (0.3%) 1 0/376 (0%) 0 0/377 (0%) 0
    PNEUMOPERITONEUM 1/371 (0.3%) 1 0/376 (0%) 0 0/377 (0%) 0
    RECTAL HAEMORRHAGE 3/371 (0.8%) 3 0/376 (0%) 0 0/377 (0%) 0
    SMALL INTESTINAL OBSTRUCTION 18/371 (4.9%) 21 13/376 (3.5%) 17 11/377 (2.9%) 14
    SMALL INTESTINAL PERFORATION 0/371 (0%) 0 1/376 (0.3%) 1 0/377 (0%) 0
    SPIGELIAN HERNIA 0/371 (0%) 0 0/376 (0%) 0 1/377 (0.3%) 1
    UPPER GASTROINTESTINAL HAEMORRHAGE 0/371 (0%) 0 0/376 (0%) 0 1/377 (0.3%) 1
    VOMITING 5/371 (1.3%) 5 10/376 (2.7%) 10 12/377 (3.2%) 16
    General disorders
    ASTHENIA 0/371 (0%) 0 0/376 (0%) 0 1/377 (0.3%) 1
    CHEST DISCOMFORT 0/371 (0%) 0 1/376 (0.3%) 1 0/377 (0%) 0
    CHEST PAIN 1/371 (0.3%) 1 0/376 (0%) 0 0/377 (0%) 0
    CHILLS 0/371 (0%) 0 0/376 (0%) 0 2/377 (0.5%) 2
    DISEASE PROGRESSION 0/371 (0%) 0 1/376 (0.3%) 1 0/377 (0%) 0
    FATIGUE 0/371 (0%) 0 0/376 (0%) 0 2/377 (0.5%) 3
    HERNIA 1/371 (0.3%) 1 0/376 (0%) 0 0/377 (0%) 0
    INCARCERATED HERNIA 1/371 (0.3%) 1 0/376 (0%) 0 0/377 (0%) 0
    NON-CARDIAC CHEST PAIN 1/371 (0.3%) 1 0/376 (0%) 0 4/377 (1.1%) 4
    PAIN 1/371 (0.3%) 1 0/376 (0%) 0 1/377 (0.3%) 1
    PELVIC MASS 0/371 (0%) 0 0/376 (0%) 0 1/377 (0.3%) 1
    PYREXIA 6/371 (1.6%) 6 3/376 (0.8%) 3 9/377 (2.4%) 9
    Hepatobiliary disorders
    BILE DUCT STONE 0/371 (0%) 0 0/376 (0%) 0 1/377 (0.3%) 1
    CHOLECYSTITIS 1/371 (0.3%) 1 0/376 (0%) 0 1/377 (0.3%) 1
    CHOLECYSTITIS ACUTE 0/371 (0%) 0 0/376 (0%) 0 2/377 (0.5%) 2
    Immune system disorders
    ANAPHYLACTIC REACTION 1/371 (0.3%) 1 1/376 (0.3%) 1 1/377 (0.3%) 1
    DRUG HYPERSENSITIVITY 1/371 (0.3%) 1 2/376 (0.5%) 2 2/377 (0.5%) 2
    Infections and infestations
    ABDOMINAL ABSCESS 1/371 (0.3%) 1 3/376 (0.8%) 3 1/377 (0.3%) 1
    BACTERAEMIA 1/371 (0.3%) 1 1/376 (0.3%) 1 1/377 (0.3%) 1
    BACTEROIDES BACTERAEMIA 0/371 (0%) 0 0/376 (0%) 0 1/377 (0.3%) 1
    BRONCHITIS 1/371 (0.3%) 1 0/376 (0%) 0 1/377 (0.3%) 1
    CATHETER SITE INFECTION 3/371 (0.8%) 3 0/376 (0%) 0 0/377 (0%) 0
    CELLULITIS 1/371 (0.3%) 1 2/376 (0.5%) 2 1/377 (0.3%) 1
    CLOSTRIDIUM DIFFICILE COLITIS 0/371 (0%) 0 2/376 (0.5%) 2 1/377 (0.3%) 1
    CLOSTRIDIUM DIFFICILE INFECTION 3/371 (0.8%) 4 1/376 (0.3%) 1 1/377 (0.3%) 1
    COLONIC ABSCESS 1/371 (0.3%) 1 0/376 (0%) 0 0/377 (0%) 0
    CYSTITIS 0/371 (0%) 0 0/376 (0%) 0 1/377 (0.3%) 1
    DEVICE RELATED INFECTION 2/371 (0.5%) 2 0/376 (0%) 0 0/377 (0%) 0
    DIVERTICULITIS 0/371 (0%) 0 1/376 (0.3%) 1 0/377 (0%) 0
    EMPYEMA 0/371 (0%) 0 1/376 (0.3%) 1 0/377 (0%) 0
    ENDOCARDITIS 0/371 (0%) 0 1/376 (0.3%) 1 0/377 (0%) 0
    ENTEROBACTER INFECTION 0/371 (0%) 0 0/376 (0%) 0 1/377 (0.3%) 1
    ENTEROCOCCAL BACTERAEMIA 0/371 (0%) 0 1/376 (0.3%) 1 0/377 (0%) 0
    ENTEROCOLITIS INFECTIOUS 0/371 (0%) 0 0/376 (0%) 0 1/377 (0.3%) 2
    ERYSIPELAS 0/371 (0%) 0 0/376 (0%) 0 1/377 (0.3%) 1
    ESCHERICHIA INFECTION 0/371 (0%) 0 1/376 (0.3%) 1 0/377 (0%) 0
    ESCHERICHIA URINARY TRACT INFECTION 0/371 (0%) 0 0/376 (0%) 0 1/377 (0.3%) 1
    GASTROENTERITIS 0/371 (0%) 0 0/376 (0%) 0 1/377 (0.3%) 1
    GASTROENTERITIS VIRAL 0/371 (0%) 0 0/376 (0%) 0 1/377 (0.3%) 1
    GROIN ABSCESS 0/371 (0%) 0 1/376 (0.3%) 1 0/377 (0%) 0
    HERPES ZOSTER 2/371 (0.5%) 2 0/376 (0%) 0 0/377 (0%) 0
    INFECTED LYMPHOCELE 0/371 (0%) 0 1/376 (0.3%) 1 2/377 (0.5%) 2
    INFECTIOUS COLITIS 0/371 (0%) 0 0/376 (0%) 0 1/377 (0.3%) 1
    INFLUENZA 0/371 (0%) 0 3/376 (0.8%) 3 3/377 (0.8%) 3
    INTERVERTEBRAL DISCITIS 0/371 (0%) 0 1/376 (0.3%) 1 0/377 (0%) 0
    LOWER RESPIRATORY TRACT INFECTION 1/371 (0.3%) 1 0/376 (0%) 0 0/377 (0%) 0
    LUNG INFECTION 2/371 (0.5%) 3 0/376 (0%) 0 1/377 (0.3%) 1
    LYMPHANGITIS 1/371 (0.3%) 1 1/376 (0.3%) 1 0/377 (0%) 0
    MENINGITIS CRYPTOCOCCAL 0/371 (0%) 0 0/376 (0%) 0 1/377 (0.3%) 1
    MYCOBACTERIAL INFECTION 0/371 (0%) 0 1/376 (0.3%) 2 0/377 (0%) 0
    NAIL INFECTION 0/371 (0%) 0 0/376 (0%) 0 1/377 (0.3%) 1
    NASOPHARYNGITIS 0/371 (0%) 0 1/376 (0.3%) 1 0/377 (0%) 0
    NEUTROPENIC SEPSIS 0/371 (0%) 0 1/376 (0.3%) 1 0/377 (0%) 0
    OPHTHALMIC HERPES ZOSTER 0/371 (0%) 0 0/376 (0%) 0 1/377 (0.3%) 2
    OSTEOMYELITIS 1/371 (0.3%) 1 1/376 (0.3%) 1 0/377 (0%) 0
    OTITIS MEDIA 0/371 (0%) 0 1/376 (0.3%) 1 0/377 (0%) 0
    PELVIC ABSCESS 1/371 (0.3%) 1 2/376 (0.5%) 2 1/377 (0.3%) 1
    PELVIC INFECTION 1/371 (0.3%) 1 0/376 (0%) 0 0/377 (0%) 0
    PERIORBITAL CELLULITIS 0/371 (0%) 0 1/376 (0.3%) 2 0/377 (0%) 0
    PERITONEAL ABSCESS 0/371 (0%) 0 1/376 (0.3%) 1 1/377 (0.3%) 1
    PERITONITIS 2/371 (0.5%) 2 0/376 (0%) 0 0/377 (0%) 0
    PERITONITIS BACTERIAL 1/371 (0.3%) 1 0/376 (0%) 0 0/377 (0%) 0
    PHARYNGITIS STREPTOCOCCAL 0/371 (0%) 0 0/376 (0%) 0 1/377 (0.3%) 1
    PHLEBITIS INFECTIVE 0/371 (0%) 0 0/376 (0%) 0 1/377 (0.3%) 1
    PNEUMONIA 4/371 (1.1%) 4 5/376 (1.3%) 5 3/377 (0.8%) 4
    POST PROCEDURAL INFECTION 0/371 (0%) 0 0/376 (0%) 0 1/377 (0.3%) 1
    POSTOPERATIVE ABSCESS 0/371 (0%) 0 0/376 (0%) 0 1/377 (0.3%) 1
    POSTOPERATIVE WOUND INFECTION 1/371 (0.3%) 1 2/376 (0.5%) 2 1/377 (0.3%) 2
    PYELONEPHRITIS 0/371 (0%) 0 0/376 (0%) 0 1/377 (0.3%) 1
    PYELONEPHRITIS ACUTE 0/371 (0%) 0 0/376 (0%) 0 2/377 (0.5%) 2
    RESPIRATORY TRACT INFECTION 0/371 (0%) 0 0/376 (0%) 0 1/377 (0.3%) 1
    SEPSIS 7/371 (1.9%) 7 2/376 (0.5%) 2 4/377 (1.1%) 5
    SEPTIC EMBOLUS 0/371 (0%) 0 1/376 (0.3%) 1 0/377 (0%) 0
    SEPTIC SHOCK 5/371 (1.3%) 6 3/376 (0.8%) 3 4/377 (1.1%) 5
    STAPHYLOCOCCAL INFECTION 1/371 (0.3%) 1 0/376 (0%) 0 0/377 (0%) 0
    STAPHYLOCOCCAL SEPSIS 0/371 (0%) 0 1/376 (0.3%) 1 0/377 (0%) 0
    SUBCUTANEOUS ABSCESS 1/371 (0.3%) 1 0/376 (0%) 0 0/377 (0%) 0
    SUBDIAPHRAGMATIC ABSCESS 1/371 (0.3%) 1 0/376 (0%) 0 0/377 (0%) 0
    SYSTEMIC CANDIDA 1/371 (0.3%) 1 0/376 (0%) 0 0/377 (0%) 0
    UPPER RESPIRATORY TRACT INFECTION 0/371 (0%) 0 2/376 (0.5%) 2 2/377 (0.5%) 2
    URINARY TRACT INFECTION 4/371 (1.1%) 5 6/376 (1.6%) 6 7/377 (1.9%) 7
    UROSEPSIS 1/371 (0.3%) 1 1/376 (0.3%) 1 1/377 (0.3%) 1
    VIRAL INFECTION 0/371 (0%) 0 1/376 (0.3%) 1 0/377 (0%) 0
    WOUND INFECTION 2/371 (0.5%) 2 2/376 (0.5%) 2 0/377 (0%) 0
    Injury, poisoning and procedural complications
    ACETABULUM FRACTURE 1/371 (0.3%) 1 0/376 (0%) 0 0/377 (0%) 0
    ANASTOMOTIC LEAK 1/371 (0.3%) 1 1/376 (0.3%) 1 0/377 (0%) 0
    ANKLE FRACTURE 2/371 (0.5%) 2 0/376 (0%) 0 0/377 (0%) 0
    CONCUSSION 0/371 (0%) 0 1/376 (0.3%) 1 0/377 (0%) 0
    FALL 7/371 (1.9%) 7 0/376 (0%) 0 0/377 (0%) 0
    FEMUR FRACTURE 1/371 (0.3%) 1 1/376 (0.3%) 1 0/377 (0%) 0
    FRACTURED SACRUM 1/371 (0.3%) 1 0/376 (0%) 0 0/377 (0%) 0
    GASTROINTESTINAL STOMA COMPLICATION 0/371 (0%) 0 0/376 (0%) 0 1/377 (0.3%) 1
    HEAT ILLNESS 0/371 (0%) 0 1/376 (0.3%) 1 0/377 (0%) 0
    INCISIONAL HERNIA 1/371 (0.3%) 1 0/376 (0%) 0 1/377 (0.3%) 1
    INTESTINAL ANASTOMOSIS COMPLICATION 1/371 (0.3%) 1 0/376 (0%) 0 0/377 (0%) 0
    JOINT DISLOCATION 0/371 (0%) 0 0/376 (0%) 0 1/377 (0.3%) 1
    LUMBAR VERTEBRAL FRACTURE 1/371 (0.3%) 1 0/376 (0%) 0 0/377 (0%) 0
    MULTIPLE INJURIES 0/371 (0%) 0 1/376 (0.3%) 1 0/377 (0%) 0
    PELVIC FRACTURE 1/371 (0.3%) 1 0/376 (0%) 0 0/377 (0%) 0
    POST PROCEDURAL HAEMORRHAGE 0/371 (0%) 0 1/376 (0.3%) 1 0/377 (0%) 0
    PROCEDURAL COMPLICATION 0/371 (0%) 0 0/376 (0%) 0 1/377 (0.3%) 1
    RIB FRACTURE 1/371 (0.3%) 1 0/376 (0%) 0 0/377 (0%) 0
    SKELETAL INJURY 1/371 (0.3%) 1 0/376 (0%) 0 0/377 (0%) 0
    SPINAL COMPRESSION FRACTURE 0/371 (0%) 0 0/376 (0%) 0 1/377 (0.3%) 1
    SPINAL FRACTURE 1/371 (0.3%) 1 0/376 (0%) 0 0/377 (0%) 0
    THORACIC VERTEBRAL FRACTURE 1/371 (0.3%) 1 0/376 (0%) 0 0/377 (0%) 0
    VAGINAL CUFF DEHISCENCE 0/371 (0%) 0 1/376 (0.3%) 2 0/377 (0%) 0
    WOUND COMPLICATION 0/371 (0%) 0 1/376 (0.3%) 1 0/377 (0%) 0
    WOUND DECOMPOSITION 0/371 (0%) 0 1/376 (0.3%) 1 0/377 (0%) 0
    WOUND DEHISCENCE 1/371 (0.3%) 1 1/376 (0.3%) 1 1/377 (0.3%) 1
    Investigations
    INTERNATIONAL NORMALISED RATIO INCREASED 0/371 (0%) 0 0/376 (0%) 0 1/377 (0.3%) 1
    SOLUBLE FIBRIN MONOMER COMPLEX INCREASED 0/371 (0%) 0 0/376 (0%) 0 1/377 (0.3%) 1
    Metabolism and nutrition disorders
    DECREASED APPETITE 0/371 (0%) 0 0/376 (0%) 0 1/377 (0.3%) 1
    DEHYDRATION 6/371 (1.6%) 6 0/376 (0%) 0 6/377 (1.6%) 6
    DIABETES MELLITUS 0/371 (0%) 0 1/376 (0.3%) 1 0/377 (0%) 0
    HYPERKALAEMIA 1/371 (0.3%) 1 1/376 (0.3%) 1 0/377 (0%) 0
    HYPOALBUMINAEMIA 1/371 (0.3%) 1 0/376 (0%) 0 1/377 (0.3%) 1
    HYPOCALCAEMIA 0/371 (0%) 0 0/376 (0%) 0 1/377 (0.3%) 1
    HYPOKALAEMIA 0/371 (0%) 0 1/376 (0.3%) 1 3/377 (0.8%) 3
    HYPONATRAEMIA 2/371 (0.5%) 2 1/376 (0.3%) 1 6/377 (1.6%) 7
    Musculoskeletal and connective tissue disorders
    FLANK PAIN 0/371 (0%) 0 0/376 (0%) 0 1/377 (0.3%) 1
    INTERVERTEBRAL DISC PROTRUSION 0/371 (0%) 0 0/376 (0%) 0 1/377 (0.3%) 1
    MUSCULAR WEAKNESS 1/371 (0.3%) 1 0/376 (0%) 0 0/377 (0%) 0
    OSTEOARTHRITIS 0/371 (0%) 0 0/376 (0%) 0 1/377 (0.3%) 1
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    ACUTE MYELOID LEUKAEMIA 0/371 (0%) 0 0/376 (0%) 0 1/377 (0.3%) 1
    MALIGNANT NEOPLASM PROGRESSION 14/371 (3.8%) 14 10/376 (2.7%) 11 3/377 (0.8%) 4
    MALIGNANT PLEURAL EFFUSION 0/371 (0%) 0 2/376 (0.5%) 2 0/377 (0%) 0
    METASTASES TO CENTRAL NERVOUS SYSTEM 0/371 (0%) 0 0/376 (0%) 0 1/377 (0.3%) 1
    NEOPLASM MALIGNANT 1/371 (0.3%) 1 0/376 (0%) 0 0/377 (0%) 0
    OVARIAN CANCER 0/371 (0%) 0 0/376 (0%) 0 1/377 (0.3%) 1
    Nervous system disorders
    CEREBRAL ARTERY EMBOLISM 1/371 (0.3%) 1 0/376 (0%) 0 0/377 (0%) 0
    CEREBRAL INFARCTION 0/371 (0%) 0 0/376 (0%) 0 1/377 (0.3%) 1
    CEREBROVASCULAR ACCIDENT 1/371 (0.3%) 1 1/376 (0.3%) 1 0/377 (0%) 0
    HEADACHE 0/371 (0%) 0 1/376 (0.3%) 1 0/377 (0%) 0
    HYPERSOMNIA 0/371 (0%) 0 1/376 (0.3%) 1 0/377 (0%) 0
    INTRACRANIAL VENOUS SINUS THROMBOSIS 0/371 (0%) 0 0/376 (0%) 0 1/377 (0.3%) 1
    LOSS OF CONSCIOUSNESS 0/371 (0%) 0 1/376 (0.3%) 1 0/377 (0%) 0
    MIGRAINE 0/371 (0%) 0 0/376 (0%) 0 1/377 (0.3%) 1
    MIGRAINE WITH AURA 1/371 (0.3%) 1 0/376 (0%) 0 0/377 (0%) 0
    NEURALGIA 1/371 (0.3%) 1 0/376 (0%) 0 0/377 (0%) 0
    SYNCOPE 6/371 (1.6%) 6 1/376 (0.3%) 1 6/377 (1.6%) 6
    TRANSIENT ISCHAEMIC ATTACK 1/371 (0.3%) 1 0/376 (0%) 0 0/377 (0%) 0
    Product Issues
    DEVICE BREAKAGE 1/371 (0.3%) 1 0/376 (0%) 0 0/377 (0%) 0
    DEVICE DISLOCATION 0/371 (0%) 0 0/376 (0%) 0 1/377 (0.3%) 1
    Psychiatric disorders
    ANXIETY 0/371 (0%) 0 0/376 (0%) 0 1/377 (0.3%) 1
    CONFUSIONAL STATE 1/371 (0.3%) 1 0/376 (0%) 0 0/377 (0%) 0
    DEPRESSION 0/371 (0%) 0 1/376 (0.3%) 1 1/377 (0.3%) 1
    MENTAL STATUS CHANGES 0/371 (0%) 0 0/376 (0%) 0 1/377 (0.3%) 1
    SUICIDE ATTEMPT 1/371 (0.3%) 1 0/376 (0%) 0 1/377 (0.3%) 1
    Renal and urinary disorders
    ACUTE KIDNEY INJURY 2/371 (0.5%) 2 1/376 (0.3%) 1 2/377 (0.5%) 2
    HAEMATURIA 0/371 (0%) 0 1/376 (0.3%) 1 1/377 (0.3%) 1
    HYDRONEPHROSIS 0/371 (0%) 0 0/376 (0%) 0 1/377 (0.3%) 1
    RENAL VEIN THROMBOSIS 1/371 (0.3%) 1 0/376 (0%) 0 0/377 (0%) 0
    URETEROLITHIASIS 1/371 (0.3%) 1 0/376 (0%) 0 0/377 (0%) 0
    URINARY RETENTION 0/371 (0%) 0 0/376 (0%) 0 1/377 (0.3%) 1
    Reproductive system and breast disorders
    FEMALE GENITAL TRACT FISTULA 0/371 (0%) 0 1/376 (0.3%) 1 0/377 (0%) 0
    VAGINAL HAEMORRHAGE 0/371 (0%) 0 0/376 (0%) 0 1/377 (0.3%) 1
    Respiratory, thoracic and mediastinal disorders
    ACUTE RESPIRATORY DISTRESS SYNDROME 0/371 (0%) 0 0/376 (0%) 0 1/377 (0.3%) 1
    ACUTE RESPIRATORY FAILURE 1/371 (0.3%) 1 1/376 (0.3%) 1 0/377 (0%) 0
    CHRONIC OBSTRUCTIVE PULMONARY DISEASE 0/371 (0%) 0 1/376 (0.3%) 1 0/377 (0%) 0
    COUGH 0/371 (0%) 0 0/376 (0%) 0 1/377 (0.3%) 1
    DYSPNOEA 1/371 (0.3%) 1 2/376 (0.5%) 2 1/377 (0.3%) 1
    DYSPNOEA EXERTIONAL 0/371 (0%) 0 1/376 (0.3%) 1 0/377 (0%) 0
    HAEMOPTYSIS 1/371 (0.3%) 1 0/376 (0%) 0 0/377 (0%) 0
    PLEURAL EFFUSION 4/371 (1.1%) 4 7/376 (1.9%) 7 0/377 (0%) 0
    PNEUMONIA ASPIRATION 2/371 (0.5%) 2 1/376 (0.3%) 1 1/377 (0.3%) 1
    PNEUMOTHORAX 0/371 (0%) 0 2/376 (0.5%) 2 0/377 (0%) 0
    PNEUMOTHORAX SPONTANEOUS 1/371 (0.3%) 1 0/376 (0%) 0 0/377 (0%) 0
    PULMONARY EMBOLISM 10/371 (2.7%) 10 10/376 (2.7%) 11 12/377 (3.2%) 13
    PULMONARY THROMBOSIS 1/371 (0.3%) 1 0/376 (0%) 0 0/377 (0%) 0
    RESPIRATORY FAILURE 0/371 (0%) 0 0/376 (0%) 0 1/377 (0.3%) 1
    RESPIRATORY TRACT CONGESTION 0/371 (0%) 0 0/376 (0%) 0 1/377 (0.3%) 1
    Vascular disorders
    DEEP VEIN THROMBOSIS 2/371 (0.5%) 2 2/376 (0.5%) 2 4/377 (1.1%) 4
    EMBOLISM 1/371 (0.3%) 1 0/376 (0%) 0 1/377 (0.3%) 1
    HYPERTENSION 1/371 (0.3%) 1 0/376 (0%) 0 0/377 (0%) 0
    HYPOTENSION 1/371 (0.3%) 1 2/376 (0.5%) 2 1/377 (0.3%) 1
    JUGULAR VEIN THROMBOSIS 2/371 (0.5%) 2 0/376 (0%) 0 2/377 (0.5%) 2
    LYMPHOCELE 0/371 (0%) 0 1/376 (0.3%) 1 0/377 (0%) 0
    PHLEBITIS 0/371 (0%) 0 0/376 (0%) 0 1/377 (0.3%) 1
    SUBCLAVIAN VEIN THROMBOSIS 1/371 (0.3%) 1 0/376 (0%) 0 0/377 (0%) 0
    THROMBOPHLEBITIS 0/371 (0%) 0 1/376 (0.3%) 1 0/377 (0%) 0
    VENOUS THROMBOSIS 0/371 (0%) 0 0/376 (0%) 0 1/377 (0.3%) 1
    Other (Not Including Serious) Adverse Events
    Placebo + Carboplatin + Paclitaxel -> Placebo Veliparib + Carboplatin + Paclitaxel -> Placebo Veliparib + Carboplatin + Paclitaxel -> Veliparib
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 369/371 (99.5%) 375/376 (99.7%) 376/377 (99.7%)
    Blood and lymphatic system disorders
    ANAEMIA 191/371 (51.5%) 513 232/376 (61.7%) 597 226/377 (59.9%) 657
    LEUKOPENIA 89/371 (24%) 223 86/376 (22.9%) 260 112/377 (29.7%) 325
    LYMPHOPENIA 15/371 (4%) 28 15/376 (4%) 20 26/377 (6.9%) 57
    NEUTROPENIA 245/371 (66%) 680 265/376 (70.5%) 875 272/377 (72.1%) 840
    THROMBOCYTOPENIA 119/371 (32.1%) 266 216/376 (57.4%) 626 209/377 (55.4%) 721
    Eye disorders
    VISION BLURRED 31/371 (8.4%) 33 19/376 (5.1%) 22 27/377 (7.2%) 27
    Gastrointestinal disorders
    ABDOMINAL DISTENSION 45/371 (12.1%) 55 48/376 (12.8%) 54 34/377 (9%) 39
    ABDOMINAL PAIN 113/371 (30.5%) 162 104/376 (27.7%) 142 118/377 (31.3%) 162
    ABDOMINAL PAIN UPPER 29/371 (7.8%) 38 18/376 (4.8%) 24 28/377 (7.4%) 36
    CONSTIPATION 157/371 (42.3%) 203 176/376 (46.8%) 238 163/377 (43.2%) 225
    DIARRHOEA 149/371 (40.2%) 246 136/376 (36.2%) 225 164/377 (43.5%) 254
    DRY MOUTH 19/371 (5.1%) 20 10/376 (2.7%) 12 22/377 (5.8%) 23
    DYSPEPSIA 41/371 (11.1%) 54 45/376 (12%) 55 35/377 (9.3%) 41
    GASTROOESOPHAGEAL REFLUX DISEASE 22/371 (5.9%) 23 28/376 (7.4%) 30 35/377 (9.3%) 47
    NAUSEA 247/371 (66.6%) 425 258/376 (68.6%) 432 289/377 (76.7%) 575
    STOMATITIS 51/371 (13.7%) 66 47/376 (12.5%) 52 59/377 (15.6%) 67
    VOMITING 127/371 (34.2%) 210 123/376 (32.7%) 169 174/377 (46.2%) 308
    General disorders
    ASTHENIA 28/371 (7.5%) 58 36/376 (9.6%) 55 41/377 (10.9%) 64
    FATIGUE 222/371 (59.8%) 355 235/376 (62.5%) 407 257/377 (68.2%) 450
    INFLUENZA LIKE ILLNESS 17/371 (4.6%) 19 19/376 (5.1%) 26 9/377 (2.4%) 12
    MALAISE 21/371 (5.7%) 34 20/376 (5.3%) 28 31/377 (8.2%) 37
    MUCOSAL INFLAMMATION 19/371 (5.1%) 21 16/376 (4.3%) 18 18/377 (4.8%) 21
    OEDEMA PERIPHERAL 73/371 (19.7%) 84 57/376 (15.2%) 61 56/377 (14.9%) 76
    PAIN 23/371 (6.2%) 26 22/376 (5.9%) 31 21/377 (5.6%) 23
    PYREXIA 24/371 (6.5%) 27 33/376 (8.8%) 37 22/377 (5.8%) 29
    Immune system disorders
    DRUG HYPERSENSITIVITY 64/371 (17.3%) 84 48/376 (12.8%) 64 53/377 (14.1%) 58
    Infections and infestations
    NASOPHARYNGITIS 22/371 (5.9%) 27 18/376 (4.8%) 21 25/377 (6.6%) 30
    SINUSITIS 18/371 (4.9%) 26 18/376 (4.8%) 20 21/377 (5.6%) 22
    UPPER RESPIRATORY TRACT INFECTION 44/371 (11.9%) 54 29/376 (7.7%) 37 34/377 (9%) 43
    URINARY TRACT INFECTION 67/371 (18.1%) 104 64/376 (17%) 90 69/377 (18.3%) 90
    Injury, poisoning and procedural complications
    CONTUSION 13/371 (3.5%) 13 17/376 (4.5%) 21 20/377 (5.3%) 28
    PROCEDURAL PAIN 38/371 (10.2%) 47 18/376 (4.8%) 19 25/377 (6.6%) 25
    Investigations
    ALANINE AMINOTRANSFERASE INCREASED 41/371 (11.1%) 64 30/376 (8%) 54 40/377 (10.6%) 52
    ASPARTATE AMINOTRANSFERASE INCREASED 31/371 (8.4%) 46 21/376 (5.6%) 39 31/377 (8.2%) 35
    BLOOD ALKALINE PHOSPHATASE INCREASED 19/371 (5.1%) 26 10/376 (2.7%) 13 16/377 (4.2%) 21
    WEIGHT DECREASED 32/371 (8.6%) 45 41/376 (10.9%) 52 54/377 (14.3%) 71
    WEIGHT INCREASED 35/371 (9.4%) 48 26/376 (6.9%) 34 36/377 (9.5%) 51
    Metabolism and nutrition disorders
    DECREASED APPETITE 85/371 (22.9%) 101 81/376 (21.5%) 105 110/377 (29.2%) 141
    DEHYDRATION 20/371 (5.4%) 21 32/376 (8.5%) 48 30/377 (8%) 36
    HYPERGLYCAEMIA 18/371 (4.9%) 35 17/376 (4.5%) 25 27/377 (7.2%) 50
    HYPOALBUMINAEMIA 19/371 (5.1%) 31 11/376 (2.9%) 16 16/377 (4.2%) 31
    HYPOCALCAEMIA 15/371 (4%) 26 13/376 (3.5%) 16 19/377 (5%) 40
    HYPOKALAEMIA 69/371 (18.6%) 107 66/376 (17.6%) 109 59/377 (15.6%) 94
    HYPOMAGNESAEMIA 98/371 (26.4%) 198 94/376 (25%) 140 84/377 (22.3%) 141
    HYPONATRAEMIA 25/371 (6.7%) 33 19/376 (5.1%) 22 25/377 (6.6%) 34
    HYPOPHOSPHATAEMIA 21/371 (5.7%) 30 14/376 (3.7%) 17 11/377 (2.9%) 14
    Musculoskeletal and connective tissue disorders
    ARTHRALGIA 123/371 (33.2%) 189 106/376 (28.2%) 142 106/377 (28.1%) 152
    BACK PAIN 66/371 (17.8%) 88 66/376 (17.6%) 75 66/377 (17.5%) 86
    BONE PAIN 27/371 (7.3%) 46 26/376 (6.9%) 37 33/377 (8.8%) 36
    MUSCULAR WEAKNESS 23/371 (6.2%) 28 24/376 (6.4%) 34 23/377 (6.1%) 33
    MUSCULOSKELETAL PAIN 24/371 (6.5%) 30 16/376 (4.3%) 16 13/377 (3.4%) 15
    MYALGIA 75/371 (20.2%) 106 59/376 (15.7%) 80 69/377 (18.3%) 96
    PAIN IN EXTREMITY 55/371 (14.8%) 68 46/376 (12.2%) 56 50/377 (13.3%) 63
    Nervous system disorders
    DIZZINESS 89/371 (24%) 119 81/376 (21.5%) 103 98/377 (26%) 123
    DYSGEUSIA 73/371 (19.7%) 89 62/376 (16.5%) 73 89/377 (23.6%) 99
    HEADACHE 97/371 (26.1%) 136 90/376 (23.9%) 124 97/377 (25.7%) 139
    PERIPHERAL SENSORY NEUROPATHY 256/371 (69%) 413 236/376 (62.8%) 347 242/377 (64.2%) 371
    TREMOR 9/371 (2.4%) 11 7/376 (1.9%) 8 23/377 (6.1%) 26
    Psychiatric disorders
    ANXIETY 57/371 (15.4%) 71 62/376 (16.5%) 75 58/377 (15.4%) 69
    DEPRESSION 40/371 (10.8%) 47 46/376 (12.2%) 58 34/377 (9%) 42
    INSOMNIA 87/371 (23.5%) 103 121/376 (32.2%) 142 110/377 (29.2%) 135
    Renal and urinary disorders
    DYSURIA 22/371 (5.9%) 24 18/376 (4.8%) 19 16/377 (4.2%) 17
    Respiratory, thoracic and mediastinal disorders
    COUGH 58/371 (15.6%) 70 57/376 (15.2%) 63 58/377 (15.4%) 68
    DYSPNOEA 75/371 (20.2%) 106 90/376 (23.9%) 110 83/377 (22%) 109
    EPISTAXIS 59/371 (15.9%) 70 61/376 (16.2%) 66 55/377 (14.6%) 60
    NASAL CONGESTION 26/371 (7%) 30 6/376 (1.6%) 6 18/377 (4.8%) 22
    OROPHARYNGEAL PAIN 38/371 (10.2%) 45 24/376 (6.4%) 27 27/377 (7.2%) 32
    Skin and subcutaneous tissue disorders
    ALOPECIA 215/371 (58%) 272 216/376 (57.4%) 271 197/377 (52.3%) 255
    NAIL DISCOLOURATION 20/371 (5.4%) 20 10/376 (2.7%) 10 12/377 (3.2%) 12
    PRURITUS 38/371 (10.2%) 45 32/376 (8.5%) 36 25/377 (6.6%) 29
    RASH 54/371 (14.6%) 67 52/376 (13.8%) 62 47/377 (12.5%) 52
    RASH MACULO-PAPULAR 31/371 (8.4%) 36 11/376 (2.9%) 15 22/377 (5.8%) 31
    Vascular disorders
    HOT FLUSH 49/371 (13.2%) 53 44/376 (11.7%) 48 42/377 (11.1%) 49
    HYPERTENSION 37/371 (10%) 65 38/376 (10.1%) 61 31/377 (8.2%) 55

    Limitations/Caveats

    [Not Specified]

    More Information

    Certain Agreements

    Principal Investigators are NOT employed by the organization sponsoring the study.

    AbbVie requests that any investigator or institution that plans on presenting/publishing results disclosure, provide written notification of their request 60 days prior to their presentation/publication. AbbVie requests that no presentation/publication will be instituted until 12 months after a study is completed, or after the first presentation/publication whichever occurs first. A delay may be proposed of a presentation/publication if AbbVie needs to secure patent or proprietary protection.

    Results Point of Contact

    Name/Title Global Medical Services
    Organization AbbVie
    Phone 1-800-633-9110
    Email abbvieclinicaltrials@abbvie.com
    Responsible Party:
    AbbVie
    ClinicalTrials.gov Identifier:
    NCT02470585
    Other Study ID Numbers:
    • M13-694
    • 2014-005070-11
    First Posted:
    Jun 12, 2015
    Last Update Posted:
    Jun 14, 2022
    Last Verified:
    May 1, 2022